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Th1252 details

Primary information
ID	11631
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Amino Acids, Peptides, and Proteins
Patents Number	5270057
Date of Issue	14-12-1993
Date of Expiry	20-03-2011
Drug Interaction	Fluvoxamine,Citalopram,Fluoxetine,Duloxetine,Trazodone,Paroxetine,Sertraline,Sibutramine,Nefazodone,Escitalopram,Zimelidine,Dapoxetine,Milnacipran,Desvenlafaxine,Seproxetine,Levomilnacipran,Indalpine,Ritanserin,Alaproclate,Amphetamine,Phentermine,Midodrine,Norepinephrine,Phenylephrine,Phenylpropanolamine,Metaraminol,Epinephrine,Methoxamine,Orciprenaline,Phenmetrazine,Dobutamine,Pseudoephedrine,Benzphetamine,Ritodrine,Terbutaline,Oxymetazoline,Diethylpropion,Dopamine,Isoprenaline,Lisdexamfetamine,Fenoterol,Ephedrine,Mephentermine,Procaterol,Clenbuterol,MMDA,Midomafetamine,2,5-Dimethoxy-4-ethylamphetamine,4-Bromo-2,5-dimethoxyamphetamine,Tenamfetamine,Chlorphentermine,Methylenedioxyethamphetamine,Dextroamphetamine,Metamfetamine,Nylidrin,Tetryzoline,Tyramine,Isoxsuprine,Etilefrine,Synephrine,Iofetamine I-123,Racepinephrine,Ritobegron,Tramazoline,Mephedrone,Fenozolone,Methoxyphenamine,Tretoquinol,Gepefrine,Prenalterol,Mefenorex,2,5-Dimethoxy-4-ethylthioamphetamine,Labetalol,Acebutolol,Celiprolol,Bucindolol,Epanolol,Gefitinib,Sorafenib,Erlotinib,Imatinib,Dasatinib,Lapatinib,Sunitinib,Genistein,3-[4-(1-formylpiperazin-4-yl)-benzylidenyl]-2-indolinone,Geldanamycin,PD173955,Radicicol,Cediranib,Nilotinib,Vatalanib,Vandetanib,Canertinib,Tandutinib,Motesanib,Dovitinib,Glesatinib,Lestaurtinib,Pazopanib,Midostaurin,Bosutinib,Axitinib,Piceatannol,Crizotinib,Cabozantinib,Ruxolitinib,Vemurafenib,Regorafenib,Ponatinib,Afatinib,Ibrutinib,Ceritinib,Lenvatinib,Nintedanib,Osimertinib,Alectinib,Selumetinib,Pacritinib,Acalabrutinib,Icotinib,Saracatinib,Neratinib,Crenolanib,Flumatinib,Dacomitinib,Tesevatinib,Entrectinib,Fostamatinib,Savolitinib,Gilteritinib,Erdafitinib,Brigatinib,Foretinib,Radotinib,Larotrectinib,Pexidartinib,Fedratinib,Tucatinib,Capmatinib,Selpercatinib,Tepotinib,Tivozanib,Infigratinib,Interferon alfa,Aldesleukin,Lovastatin,Ethionamide,Diazepam,Perphenazine,Metoclopramide,Perphenazine enanthate,Aminosalicylic acid,Resorcinol,Glimepiride,Acetohexamide,Chlorpropamide,Tolazamide,Glyburide,Glipizide,Gliclazide,Tolbutamide,Gliquidone,Glisoxepide,Glibornuride,Carbutamide,Metahexamide,Nortriptyline,Amitriptyline,Protriptyline,Imipramine,Amoxapine,Trimipramine,Doxepin,Desipramine,Clomipramine,Amineptine,Dimetacrine,Butriptyline,Dosulepin,Tianeptine,Oxaprotiline,Opipramol,Amitriptylinoxide,Dibenzepin,Quinupramine,Melitracen,Lofepramine,Iprindole,Imipramine oxide,Estetrol,Avapritinib,Naphazoline
Target	Follicle-stimulating hormone receptor
Brand Name	Bemfola
Company	Gedeon Richter Plc.
Brand Description	Gedeon Richter Plc.
Prescribed For	Subcutaneous
Chemical Name	75 IU/0.125ml
Formulation	NA
Physical Appearance	The most common side effects with Bemfola (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10. For the full list of all side effects reported with Bemfola, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11632
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Chorionic Gonadotropin
Patents Number	2037884
Date of Issue	21-10-2003
Date of Expiry	08-03-2011
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Bemfola
Company	Gedeon Richter Plc.
Brand Description	Gedeon Richter Plc.
Prescribed For	Subcutaneous
Chemical Name	150 IU/0.25ml
Formulation	NA
Physical Appearance	The most common side effects with Bemfola (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10. For the full list of all side effects reported with Bemfola, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11633
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Follicle Stimulating Hormone
Patents Number	7563763
Date of Issue	21-07-2009
Date of Expiry	23-08-2019
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Bemfola
Company	Gedeon Richter Plc.
Brand Description	Gedeon Richter Plc.
Prescribed For	Subcutaneous
Chemical Name	225 IU/0.375ml
Formulation	NA
Physical Appearance	The most common side effects with Bemfola (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10. For the full list of all side effects reported with Bemfola, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11634
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Genito Urinary System and Sex Hormones
Patents Number	5929028
Date of Issue	27-07-1999
Date of Expiry	14-01-2018
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Bemfola
Company	Gedeon Richter Plc.
Brand Description	Gedeon Richter Plc.
Prescribed For	Subcutaneous
Chemical Name	300 IU/0.50ml
Formulation	NA
Physical Appearance	The most common side effects with Bemfola (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10. For the full list of all side effects reported with Bemfola, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11635
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Gonadotropins
Patents Number	7446090
Date of Issue	04-11-2008
Date of Expiry	23-08-2019
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Bemfola
Company	Gedeon Richter Plc.
Brand Description	Gedeon Richter Plc.
Prescribed For	Subcutaneous
Chemical Name	450 IU/0.75ml
Formulation	NA
Physical Appearance	The most common side effects with Bemfola (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10. For the full list of all side effects reported with Bemfola, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11636
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Gonadotropins and Antigonadotropins
Patents Number	7741268
Date of Issue	22-06-2010
Date of Expiry	02-04-2024
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Bemfola Needles
Company	Gedeon Richter Plc.
Brand Description	Gedeon Richter Plc.
Prescribed For	Subcutaneous
Chemical Name	150 IU/0.25ml
Formulation	NA
Physical Appearance	The most common side effects with Bemfola (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10.
Route of Administration	Bemfola is a medicine that contains the active substance follitropin alfa. It is used to treat the following groups:
Recommended Dosage	Bemfola is available as a solution for injection in a prefilled pen. The medicine can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of fertility problems
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11637
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Gonadotropins, Pituitary
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Bravelle
Company	Ferring Pharmaceuticals Inc.
Brand Description	Ferring Pharmaceuticals Inc.
Prescribed For	Subcutaneous
Chemical Name	75 [iU]/1mL
Formulation	BRAVELLE® is contraindicated in women who exhibit: Prior hypersensitivity to BRAVELLE® or urofollitropins High levels of FSH indicating primary ovarian failure [see INDICATIONS AND USAGE] Pregnancy BRAVELLE® may cause fetal harm when administered to a pregnant woman [see Use In Specific Populations]. BRAVELLE® is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the woman becomes pregnant while taking this drug, the woman should be apprised of the potential hazard to a fetus. Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see INDICATIONS AND USAGE] Sex hormone dependent tumors of the reproductive tract and accessory organ Tumors of pituitary gland or hypothalamus Abnormal uterine bleeding of undetermined origin Ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, bloating, mild pelvic pain, cramps, constipation, injection site reactions (redness, pain, swelling, itching, or irritation), breast tenderness/pain, skin rash, hot flashes, or acne
Route of Administration	Bravelle is a purified form of a hormone called follicle-stimulating hormone (FSH). This hormone is important in the development of follicles (eggs) that are produced by the ovaries in women. Bravelle is used together with other medicines to treat infertility in women with FSH deficiency. This medicine...
Recommended Dosage	Bravelle is a prescription medicine used to treat the symptoms of Ovulation Induction, Assisted Reproductive Technology (ART), and Spermatogenesis. Bravelle may be used alone or with other medications.
Contraindication	NA
Side Effects	BRAVELLE® is a product containing a highly purified preparation of human follicle stimulating hormone (hFSH) extracted from the urine of postmenopausal women. Human FSH is a gonadotropin and consists of two non-covalently linked glycoproteins designated as the α and β subunits. The α subunit has 92 amino acids of which two are modified by attachment of carbohydrates. The β subunit has 111 amino acids of which two are modified by attachment of carbohydrates.
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11638
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Hormones
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Fertavid
Company	Merck Sharp & Dohme B.V.
Brand Description	Merck Sharp & Dohme B.V.
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	50 IU/0.5mL
Formulation	NA
Physical Appearance	NA
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11639
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Hormones, Hormone Substitutes, and Hormone Antagonists
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Fertavid
Company	Merck Sharp & Dohme B.V.
Brand Description	Merck Sharp & Dohme B.V.
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	75 IU/0.5mL
Formulation	NA
Physical Appearance	NA
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11640
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Peptide Hormones
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Fertavid
Company	Merck Sharp & Dohme B.V.
Brand Description	Merck Sharp & Dohme B.V.
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	100 IU/0.5mL
Formulation	NA
Physical Appearance	NA
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11641
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Peptides
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Fertavid
Company	Merck Sharp & Dohme B.V.
Brand Description	Merck Sharp & Dohme B.V.
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	150 IU/0.5mL
Formulation	NA
Physical Appearance	NA
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11642
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Pituitary Hormones
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Fertavid
Company	Merck Sharp & Dohme B.V.
Brand Description	Merck Sharp & Dohme B.V.
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	200 IU/0.5mL
Formulation	NA
Physical Appearance	NA
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11643
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Pituitary Hormones, Anterior
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Fertavid
Company	Merck Sharp & Dohme B.V.
Brand Description	Merck Sharp & Dohme B.V.
Prescribed For	Subcutaneous
Chemical Name	150 IU/0.18mL
Formulation	NA
Physical Appearance	NA
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11644
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Placental Hormones
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Fertavid
Company	Merck Sharp & Dohme B.V.
Brand Description	Merck Sharp & Dohme B.V.
Prescribed For	Subcutaneous
Chemical Name	300 IU/0.36mL
Formulation	NA
Physical Appearance	NA
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11645
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Pregnancy Proteins
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Fertavid
Company	Merck Sharp & Dohme B.V.
Brand Description	Merck Sharp & Dohme B.V.
Prescribed For	Subcutaneous
Chemical Name	600 IU/0.72mL
Formulation	NA
Physical Appearance	NA
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11646
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Proteins
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Fertavid
Company	Merck Sharp & Dohme B.V.
Brand Description	Merck Sharp & Dohme B.V.
Prescribed For	Subcutaneous
Chemical Name	900 IU/1.08mL
Formulation	NA
Physical Appearance	NA
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11647
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Sex Hormones and Modulators of the Genital System
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Follistim
Company	Organon USA, Inc.
Brand Description	Organon USA, Inc.
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	NA
Formulation	Follistim® AQ (follitropin beta injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant hFSH products. High levels of FSH indicating primary ovarian failure. Uncontrolled thyroid or adrenal dysfunction. Tumor of the ovary, breast, uterus, hypothalamus or pituitary gland. Pregnancy. Heavy or irregular vaginal bleeding of undetermined origin. Ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS). Hypersensitivity reactions to streptomycin or neomycin. Follistim® AQ (follitropin beta) may contain traces of these antibiotics and may cause hypersensitivity reactions in susceptible persons.
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Follistim AQ is a man-made form of a hormone that occurs naturally in the body. This hormone regulates ovulation, the growth and development of eggs in a woman's ovaries. Follistim AQ is used to treat infertility in women who cannot ovulate. This medicine is not effective in women with primary ovarian...
Recommended Dosage	Follistim is a prescription medicine used to treat infertility in women to induce Ovulation and to stimulate sperm production in men (Spermatogenesis). Follistim may be used alone or with other medications.
Contraindication	NA
Side Effects	FOR SUBCUTANEOUS OR INTRAMUSCULAR USE ONLY
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11648
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	Thyroid Products
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Follistim AQ
Company	Organon USA, Inc.
Brand Description	Organon USA, Inc.
Prescribed For	Subcutaneous
Chemical Name	175 [iU]/0.210mL
Formulation	Follistim® AQ (follitropin beta injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant hFSH products. High levels of FSH indicating primary ovarian failure. Uncontrolled thyroid or adrenal dysfunction. Tumor of the ovary, breast, uterus, hypothalamus or pituitary gland. Pregnancy. Heavy or irregular vaginal bleeding of undetermined origin. Ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS). Hypersensitivity reactions to streptomycin or neomycin. Follistim® AQ (follitropin beta) may contain traces of these antibiotics and may cause hypersensitivity reactions in susceptible persons.
Physical Appearance	The following adverse events have been reported in women treated with gonado tropins: pulmonary and vascular complications, hemoperitoneum, adnexal torsion (as a complication of ovarian enlargement), dizziness, tachycardia, dyspnea, tachypnea, febrile reactions, flu-like symptoms including fever, chills, mus culoskeletal aches, joint pains, nausea, headache and malaise, breast tenderness, and dermatological symptoms
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11649
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Follistim AQ
Company	Organon USA Inc.
Brand Description	Organon USA Inc.
Prescribed For	Subcutaneous
Chemical Name	350 [iU]/0.42mL
Formulation	Follistim® AQ (follitropin beta injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant hFSH products. High levels of FSH indicating primary ovarian failure. Uncontrolled thyroid or adrenal dysfunction. Tumor of the ovary, breast, uterus, hypothalamus or pituitary gland. Pregnancy. Heavy or irregular vaginal bleeding of undetermined origin. Ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS). Hypersensitivity reactions to streptomycin or neomycin. Follistim® AQ (follitropin beta) may contain traces of these antibiotics and may cause hypersensitivity reactions in susceptible persons.
Physical Appearance	The following adverse events have been reported in women treated with gonado tropins: pulmonary and vascular complications, hemoperitoneum, adnexal torsion (as a complication of ovarian enlargement), dizziness, tachycardia, dyspnea, tachypnea, febrile reactions, flu-like symptoms including fever, chills, mus culoskeletal aches, joint pains, nausea, headache and malaise, breast tenderness, and dermatological symptoms
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11650
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Follistim AQ
Company	Organon USA Inc.
Brand Description	Organon USA Inc.
Prescribed For	Subcutaneous
Chemical Name	650 [iU]/0.78mL
Formulation	Follistim® AQ (follitropin beta injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant hFSH products. High levels of FSH indicating primary ovarian failure. Uncontrolled thyroid or adrenal dysfunction. Tumor of the ovary, breast, uterus, hypothalamus or pituitary gland. Pregnancy. Heavy or irregular vaginal bleeding of undetermined origin. Ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS). Hypersensitivity reactions to streptomycin or neomycin. Follistim® AQ (follitropin beta) may contain traces of these antibiotics and may cause hypersensitivity reactions in susceptible persons.
Physical Appearance	The following adverse events have been reported in women treated with gonado tropins: pulmonary and vascular complications, hemoperitoneum, adnexal torsion (as a complication of ovarian enlargement), dizziness, tachycardia, dyspnea, tachypnea, febrile reactions, flu-like symptoms including fever, chills, mus culoskeletal aches, joint pains, nausea, headache and malaise, breast tenderness, and dermatological symptoms
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11651
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Follistim AQ
Company	Organon USA Inc.
Brand Description	Organon USA Inc.
Prescribed For	Subcutaneous
Chemical Name	975 [iU]/1.17mL
Formulation	Follistim® AQ (follitropin beta injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant hFSH products. High levels of FSH indicating primary ovarian failure. Uncontrolled thyroid or adrenal dysfunction. Tumor of the ovary, breast, uterus, hypothalamus or pituitary gland. Pregnancy. Heavy or irregular vaginal bleeding of undetermined origin. Ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS). Hypersensitivity reactions to streptomycin or neomycin. Follistim® AQ (follitropin beta) may contain traces of these antibiotics and may cause hypersensitivity reactions in susceptible persons.
Physical Appearance	The following adverse events have been reported in women treated with gonado tropins: pulmonary and vascular complications, hemoperitoneum, adnexal torsion (as a complication of ovarian enlargement), dizziness, tachycardia, dyspnea, tachypnea, febrile reactions, flu-like symptoms including fever, chills, mus culoskeletal aches, joint pains, nausea, headache and malaise, breast tenderness, and dermatological symptoms
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11652
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Follistim AQ
Company	Organon USA Inc.
Brand Description	Organon USA Inc.
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	75 [iU]/0.5mL
Formulation	Follistim® AQ (follitropin beta injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant hFSH products. High levels of FSH indicating primary ovarian failure. Uncontrolled thyroid or adrenal dysfunction. Tumor of the ovary, breast, uterus, hypothalamus or pituitary gland. Pregnancy. Heavy or irregular vaginal bleeding of undetermined origin. Ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS). Hypersensitivity reactions to streptomycin or neomycin. Follistim® AQ (follitropin beta) may contain traces of these antibiotics and may cause hypersensitivity reactions in susceptible persons.
Physical Appearance	The following adverse events have been reported in women treated with gonado tropins: pulmonary and vascular complications, hemoperitoneum, adnexal torsion (as a complication of ovarian enlargement), dizziness, tachycardia, dyspnea, tachypnea, febrile reactions, flu-like symptoms including fever, chills, mus culoskeletal aches, joint pains, nausea, headache and malaise, breast tenderness, and dermatological symptoms
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11653
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Follistim AQ
Company	Organon USA Inc.
Brand Description	Organon USA Inc.
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	150 [iU]/0.5mL
Formulation	Follistim® AQ (follitropin beta injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant hFSH products. High levels of FSH indicating primary ovarian failure. Uncontrolled thyroid or adrenal dysfunction. Tumor of the ovary, breast, uterus, hypothalamus or pituitary gland. Pregnancy. Heavy or irregular vaginal bleeding of undetermined origin. Ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS). Hypersensitivity reactions to streptomycin or neomycin. Follistim® AQ (follitropin beta) may contain traces of these antibiotics and may cause hypersensitivity reactions in susceptible persons.
Physical Appearance	The following adverse events have been reported in women treated with gonado tropins: pulmonary and vascular complications, hemoperitoneum, adnexal torsion (as a complication of ovarian enlargement), dizziness, tachycardia, dyspnea, tachypnea, febrile reactions, flu-like symptoms including fever, chills, mus culoskeletal aches, joint pains, nausea, headache and malaise, breast tenderness, and dermatological symptoms
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11654
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f
Company	EMD Serono, Inc.
Brand Description	EMD Serono, Inc.
Prescribed For	Subcutaneous
Chemical Name	450 [iU]/1mL
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11655
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f
Company	EMD Serono, Inc.
Brand Description	EMD Serono, Inc.
Prescribed For	Subcutaneous
Chemical Name	1050 [iU]/2mL
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11656
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f
Company	Emd Serono, A Division Of Emd Inc., Canada
Brand Description	Emd Serono, A Division Of Emd Inc., Canada
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	5.5 mcg / vial
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11657
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f
Company	Emd Serono, A Division Of Emd Inc., Canada
Brand Description	Emd Serono, A Division Of Emd Inc., Canada
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	33 mcg / vial
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11658
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f
Company	Emd Serono, A Division Of Emd Inc., Canada
Brand Description	Emd Serono, A Division Of Emd Inc., Canada
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	77 mcg / vial
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11659
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f
Company	Emd Serono, A Division Of Emd Inc., Canada
Brand Description	Emd Serono, A Division Of Emd Inc., Canada
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	75 unit / vial
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11660
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f
Company	Emd Serono, A Division Of Emd Inc., Canada
Brand Description	Emd Serono, A Division Of Emd Inc., Canada
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	150 unit / vial
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11661
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f
Company	Emd Serono, A Division Of Emd Inc., Canada
Brand Description	Emd Serono, A Division Of Emd Inc., Canada
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	37.5 unit / vial
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11662
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f
Company	Emd Serono, A Division Of Emd Inc., Canada
Brand Description	Emd Serono, A Division Of Emd Inc., Canada
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	1200 unit / vial
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11663
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-F
Company	Merck Europe B.V.
Brand Description	Merck Europe B.V.
Prescribed For	Subcutaneous
Chemical Name	75 IU
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11664
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-F
Company	Merck Europe B.V.
Brand Description	Merck Europe B.V.
Prescribed For	Subcutaneous
Chemical Name	1050 IU/1.75ml
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11665
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-F
Company	Merck Europe B.V.
Brand Description	Merck Europe B.V.
Prescribed For	Subcutaneous
Chemical Name	450 IU/0.75ml
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11666
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-F
Company	Merck Europe B.V.
Brand Description	Merck Europe B.V.
Prescribed For	Subcutaneous
Chemical Name	300 IU/0.5ml
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11667
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-F
Company	Merck Europe B.V.
Brand Description	Merck Europe B.V.
Prescribed For	Subcutaneous
Chemical Name	300 IU/0.5ml
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11668
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-F
Company	Merck Europe B.V.
Brand Description	Merck Europe B.V.
Prescribed For	Subcutaneous
Chemical Name	450 IU/0.75ml
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11669
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-F
Company	Merck Europe B.V.
Brand Description	Merck Europe B.V.
Prescribed For	Subcutaneous
Chemical Name	900 IU/1.5ml
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11670
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-F
Company	Merck Europe B.V.
Brand Description	Merck Europe B.V.
Prescribed For	Subcutaneous
Chemical Name	150 IU/0.25ml
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	headache, nausea, vomiting, mild stomach/abdominal pain, pelvic pain or tenderness, bloating, injection site reactions (redness, pain, bruising, irritation), breast swelling/tenderness/pain, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
Route of Administration	NA
Recommended Dosage	Gonal-F is indicated for:
Contraindication	NA
Side Effects	in women:
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11671
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-F Pen
Company	Emd Serono, A Division Of Emd Inc., Canada
Brand Description	Emd Serono, A Division Of Emd Inc., Canada
Prescribed For	Subcutaneous
Chemical Name	900 unit / 1.5 mL
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	GONAL-f is a medicine that contains the active substance follitropin alfa. It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.
Recommended Dosage	GONAL-f is used to treat the following groups:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11672
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-F Pen
Company	Emd Serono, A Division Of Emd Inc., Canada
Brand Description	Emd Serono, A Division Of Emd Inc., Canada
Prescribed For	Subcutaneous
Chemical Name	450 unit / 0.75 mL
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	GONAL-f is a medicine that contains the active substance follitropin alfa. It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.
Recommended Dosage	GONAL-f is used to treat the following groups:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11673
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-F Pen
Company	Emd Serono, A Division Of Emd Inc., Canada
Brand Description	Emd Serono, A Division Of Emd Inc., Canada
Prescribed For	Subcutaneous
Chemical Name	300 unit / 0.5 mL
Formulation	GONAL-F is contraindicated in women and men who exhibit:Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS]High levels of FSH indicating primary gonadal failureThe presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)Sex hormone dependent tumors of the reproductive tract and accessory organsTumors of pituitary gland or hypothalamusGONAL-F is also contraindicated in women who exhibit:Abnormal uterine bleeding of undetermined originOvarian cyst or enlargement of undetermined origin
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	GONAL-f is a medicine that contains the active substance follitropin alfa. It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.
Recommended Dosage	GONAL-f is used to treat the following groups:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11674
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-F Rff
Company	EMD Serono, Inc.
Brand Description	EMD Serono, Inc.
Prescribed For	Subcutaneous
Chemical Name	75 [iU]/1mL
Formulation	Gonal-f® RFF (follitropin alfa for injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant FSH preparations or one of their excipients. High levels of FSH indicating primary gonadal failure. Uncontrolled thyroid or adrenal dysfunction. Sex hormone dependent tumors of the reproductive tract and accessory organs. An organic intracranial lesion such as a pituitary tumor. Abnormal uterine bleeding of undetermined origin (see "Selection of Patients"). Ovarian cyst or enlargement of undetermined origin (see "Selection of Patients"). Pregnancy.
Physical Appearance	headache nausea vomiting mild stomach or abdominal pain bloating injection site reactions (pain, bruising, redness, or irritation) breast swelling/tenderness/pain numbness or tingly feeling, pelvic pain/tenderness/discomfort runny or stuffy nose sore throat acne or skin rash,
Route of Administration	NA
Recommended Dosage	Gonal-f RFF (follitropin alfa for injection) is a prescription medicine used to treat the symptoms of Ovulation Induction and Assisted Reproductive Technologies. Gonal-f RFF may be used alone or with other medications.
Contraindication	NA
Side Effects	Gonal-f® RFF (follitropin alfa for injection) is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the α- and β-subunits. The α- and β-subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structure are indistinguishable from those of human follicle stimulating hormone. Recombinant FSH production occurs in genetically modified Chinese Hamster Ovary (CHO) cells cultured in bioreactors. Purification by immunochromatography using an antibody specifically binding FSH results in a highly purified preparation with a consistent FSH isoform profile, and a high specific activity. The biological activity of follitropin alfa is determined by measuring the increase in ovary weight in female rats. The in vivo biological activity of follitropin alfa has been calibrated against the first International Standard for recombinant human follicle stimulating hormone established in 1995 by the Expert Committee on Biological Standards of the World Health Organization. Gonal-f® RFF (follitropin alfa injection) contains no luteinizing hormone (LH) activity. Based on available data derived from physico-chemical tests and bioassays, follitropin alfa and follitropin beta, another recombinant follicle stimulating hormone product, are indistinguishable.
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11675
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f RFF Pen
Company	Emd Serono
Brand Description	Emd Serono
Prescribed For	Subcutaneous
Chemical Name	300 [iU]/0.5mL
Formulation	Gonal-f® RFF (follitropin alfa for injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant FSH preparations or one of their excipients. High levels of FSH indicating primary gonadal failure. Uncontrolled thyroid or adrenal dysfunction. Sex hormone dependent tumors of the reproductive tract and accessory organs. An organic intracranial lesion such as a pituitary tumor. Abnormal uterine bleeding of undetermined origin (see "Selection of Patients"). Ovarian cyst or enlargement of undetermined origin (see "Selection of Patients"). Pregnancy.
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	GONAL-f is a medicine that contains the active substance follitropin alfa. It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.
Recommended Dosage	GONAL-f is used to treat the following groups:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11676
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f RFF Pen
Company	Emd Serono
Brand Description	Emd Serono
Prescribed For	Subcutaneous
Chemical Name	450 [iU]/0.75mL
Formulation	Gonal-f® RFF (follitropin alfa for injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant FSH preparations or one of their excipients. High levels of FSH indicating primary gonadal failure. Uncontrolled thyroid or adrenal dysfunction. Sex hormone dependent tumors of the reproductive tract and accessory organs. An organic intracranial lesion such as a pituitary tumor. Abnormal uterine bleeding of undetermined origin (see "Selection of Patients"). Ovarian cyst or enlargement of undetermined origin (see "Selection of Patients"). Pregnancy.
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	GONAL-f is a medicine that contains the active substance follitropin alfa. It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.
Recommended Dosage	GONAL-f is used to treat the following groups:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11677
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f RFF Pen
Company	Emd Serono
Brand Description	Emd Serono
Prescribed For	Subcutaneous
Chemical Name	900 [iU]/1.5mL
Formulation	Gonal-f® RFF (follitropin alfa for injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant FSH preparations or one of their excipients. High levels of FSH indicating primary gonadal failure. Uncontrolled thyroid or adrenal dysfunction. Sex hormone dependent tumors of the reproductive tract and accessory organs. An organic intracranial lesion such as a pituitary tumor. Abnormal uterine bleeding of undetermined origin (see "Selection of Patients"). Ovarian cyst or enlargement of undetermined origin (see "Selection of Patients"). Pregnancy.
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	GONAL-f is a medicine that contains the active substance follitropin alfa. It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.
Recommended Dosage	GONAL-f is used to treat the following groups:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11678
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f RFF Redi-ject
Company	EMD Serono, Inc.
Brand Description	EMD Serono, Inc.
Prescribed For	Subcutaneous
Chemical Name	300 [iU]/0.5mL
Formulation	Gonal-f® RFF (follitropin alfa for injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant FSH preparations or one of their excipients. High levels of FSH indicating primary gonadal failure. Uncontrolled thyroid or adrenal dysfunction. Sex hormone dependent tumors of the reproductive tract and accessory organs. An organic intracranial lesion such as a pituitary tumor. Abnormal uterine bleeding of undetermined origin (see "Selection of Patients"). Ovarian cyst or enlargement of undetermined origin (see "Selection of Patients"). Pregnancy.
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	GONAL-f is a medicine that contains the active substance follitropin alfa. It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.
Recommended Dosage	GONAL-f is used to treat the following groups:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11679
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f RFF Redi-ject
Company	EMD Serono, Inc.
Brand Description	EMD Serono, Inc.
Prescribed For	Subcutaneous
Chemical Name	450 [iU]/0.75mL
Formulation	Gonal-f® RFF (follitropin alfa for injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant FSH preparations or one of their excipients. High levels of FSH indicating primary gonadal failure. Uncontrolled thyroid or adrenal dysfunction. Sex hormone dependent tumors of the reproductive tract and accessory organs. An organic intracranial lesion such as a pituitary tumor. Abnormal uterine bleeding of undetermined origin (see "Selection of Patients"). Ovarian cyst or enlargement of undetermined origin (see "Selection of Patients"). Pregnancy.
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	GONAL-f is a medicine that contains the active substance follitropin alfa. It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.
Recommended Dosage	GONAL-f is used to treat the following groups:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11680
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f RFF Redi-ject
Company	EMD Serono, Inc.
Brand Description	EMD Serono, Inc.
Prescribed For	Subcutaneous
Chemical Name	900 [iU]/1.5mL
Formulation	Gonal-f® RFF (follitropin alfa for injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant FSH preparations or one of their excipients. High levels of FSH indicating primary gonadal failure. Uncontrolled thyroid or adrenal dysfunction. Sex hormone dependent tumors of the reproductive tract and accessory organs. An organic intracranial lesion such as a pituitary tumor. Abnormal uterine bleeding of undetermined origin (see "Selection of Patients"). Ovarian cyst or enlargement of undetermined origin (see "Selection of Patients"). Pregnancy.
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	GONAL-f is a medicine that contains the active substance follitropin alfa. It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.
Recommended Dosage	GONAL-f is used to treat the following groups:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11681
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Gonal-f RFF Redi-ject
Company	EMD Serono, Inc.
Brand Description	EMD Serono, Inc.
Prescribed For	Subcutaneous
Chemical Name	150 [iU]/0.25mL
Formulation	Gonal-f® RFF (follitropin alfa for injection) is contraindicated in women who exhibit: Prior hypersensitivity to recombinant FSH preparations or one of their excipients. High levels of FSH indicating primary gonadal failure. Uncontrolled thyroid or adrenal dysfunction. Sex hormone dependent tumors of the reproductive tract and accessory organs. An organic intracranial lesion such as a pituitary tumor. Abnormal uterine bleeding of undetermined origin (see "Selection of Patients"). Ovarian cyst or enlargement of undetermined origin (see "Selection of Patients"). Pregnancy.
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	GONAL-f is a medicine that contains the active substance follitropin alfa. It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.
Recommended Dosage	GONAL-f is used to treat the following groups:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11682
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Humegon Inj 75 I.U.
Company	Organon Canada Ltd Ltee
Brand Description	Organon Canada Ltd Ltee
Prescribed For	Intramuscular
Chemical Name	NA
Formulation	NA
Physical Appearance	Abdominal or stomach pain (severe) bloating (moderate to severe) chest pain or trouble breathing decreased amount of urine feeling of indigestion general feeling of discomfort or illness headache, severe and throbbing nausea, vomiting, or diarrhea (continuing or severe) pain or swelling in the arms or legs pelvic pain (severe) severe cramping of the uterus shortness of breath or wheezing swelling of the lower legs weight gain (rapid)
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11683
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Menopur
Company	Ferring Pharmaceuticals Inc.
Brand Description	Ferring Pharmaceuticals Inc.
Prescribed For	Subcutaneous
Chemical Name	NA
Formulation	MENOPUR® is contraindicated in women who exhibit: Prior hypersensitivity to MENOPUR® or menotropins products or one of their excipients High levels of FSH indicating primary ovarian failure [see INDICATIONS AND USAGE] Pregnancy MENOPUR® may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations]. MENOPUR® is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the woman becomes pregnant while taking this drug, the woman should be apprised of the potential hazard to a fetus. Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see INDICATIONS AND USAGE] Sex hormone dependent tumors of the reproductive tract and accessory organs Tumors of pituitary gland or hypothalamus Abnormal uterine bleeding of undetermined origin Ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome
Physical Appearance	headache, drowsiness, stomach or abdominal pain, bloating, injection site reactions (pain, swelling, irritation, redness), breast enlargement or tenderness, dizziness, nausea, vomiting, diarrhea, shortness of breath, pain/warmth/tenderness centralized in an arm or leg, fever, chills, weakness or aching of muscles or joints, or rash.
Route of Administration	Menotropins injection is used to treat infertility in women. Menotropins are a mixture of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) that are produced in the body by the pituitary gland. Menotropins injection is used in women with healthy ovaries who are enrolled in a fertility program...
Recommended Dosage	Menopur is a prescription medicine used to treat the symptoms of Ovulation Induction, Spermatogenesis and Assisted Reproductive Technology. Menopur may be used alone or with other medications.
Contraindication	NA
Side Effects	MENOPUR® is a preparation of gonadotropins (FSH and LH activity), extracted from the urine of postmenopausal women, which has undergone additional steps for purification.
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11684
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Ovaleap
Company	Theramex Ireland Limited
Brand Description	Theramex Ireland Limited
Prescribed For	Subcutaneous
Chemical Name	300 IU/0.5mL
Formulation	NA
Physical Appearance	The most common side effects with Ovaleap (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10. For the full list of all side effects reported with Ovaleap, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11685
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Ovaleap
Company	Theramex Ireland Limited
Brand Description	Theramex Ireland Limited
Prescribed For	Subcutaneous
Chemical Name	450 IU/0.75mL
Formulation	NA
Physical Appearance	The most common side effects with Ovaleap (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10. For the full list of all side effects reported with Ovaleap, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11686
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Ovaleap
Company	Theramex Ireland Limited
Brand Description	Theramex Ireland Limited
Prescribed For	Subcutaneous
Chemical Name	900 IU/1.5mL
Formulation	NA
Physical Appearance	The most common side effects with Ovaleap (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10. For the full list of all side effects reported with Ovaleap, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11687
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Pergonal 75 I.U.
Company	Emd Serono, A Division Of Emd Inc., Canada
Brand Description	Emd Serono, A Division Of Emd Inc., Canada
Prescribed For	Intramuscular
Chemical Name	NA
Formulation	NA
Physical Appearance	Back pain breast tenderness feeling of warmth, redness of the face, neck, arms, and occasionally, upper chest menstrual changes muscle aches and pains unusual tiredness or weakness
Route of Administration	Menotropins injection is used in women with healthy ovaries who are enrolled in a fertility program called assisted reproductive technology (ART). ART uses procedures such as in vitro fertilization (IVF). Menotropins is used together with human chorionic gonadotropin (hCG) in these procedures.
Recommended Dosage	Menotropins injection is used to treat infertility in women. Menotropins are a mixture of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) that are produced in the body by the pituitary gland.
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11688
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Pergoveris
Company	Emd Serono, A Division Of Emd Inc., Canada
Brand Description	Emd Serono, A Division Of Emd Inc., Canada
Prescribed For	Subcutaneous
Chemical Name	NA
Formulation	NA
Physical Appearance	The most common side effects reported with Pergoveris (seen in more than 1 patient in 10) are headache, ovarian cysts and injection site reactions (e.g. pain, itching, redness, bruising, swelling or irritation at the site of injection). Treatment can cause overstimulation of the ovaries (known as ovarian hyperstimulation syndrome, OHSS), which can lead to serious medical problems. Mild or moderate OHSS is common, while severe OHSS is uncommon. Thromboembolism (clots in the blood vessels) may occur very rarely, usually associated with severe OHSS.
Route of Administration	Pergoveris is a fertility medicine used in women to stimulate the development of follicles, the structures inside the ovaries that contain an egg.
Recommended Dosage	Pergoveris is available as a solution for injection in a pre-filled pen or as a powder and solvent to be made up into a solution for injection. Pergoveris is injected under the skin once a day until the patient has developed a suitable follicle, as assessed using ultrasound scans and by measuring blood oestrogen levels. This may take up to 5 weeks. The recommended starting dose is 150 International Units (IU) of follitropin alfa and 75 IU of lutropin alfa once a day, but this should be tailored to the patient’s response. Using less than the recommended starting dose may not be sufficient to stimulate development of a follicle. If necessary, the dose of follitropin alfa can be increased by adding it as a separate medicine, with 7 to 14 days between each dose increase.
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11689
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Pergoveris
Company	Emd Serono, A Division Of Emd Inc., Canada
Brand Description	Emd Serono, A Division Of Emd Inc., Canada
Prescribed For	Subcutaneous
Chemical Name	NA
Formulation	NA
Physical Appearance	The most common side effects reported with Pergoveris (seen in more than 1 patient in 10) are headache, ovarian cysts and injection site reactions (e.g. pain, itching, redness, bruising, swelling or irritation at the site of injection). Treatment can cause overstimulation of the ovaries (known as ovarian hyperstimulation syndrome, OHSS), which can lead to serious medical problems. Mild or moderate OHSS is common, while severe OHSS is uncommon. Thromboembolism (clots in the blood vessels) may occur very rarely, usually associated with severe OHSS.
Route of Administration	Pergoveris is a fertility medicine used in women to stimulate the development of follicles, the structures inside the ovaries that contain an egg.
Recommended Dosage	Pergoveris is available as a solution for injection in a pre-filled pen or as a powder and solvent to be made up into a solution for injection. Pergoveris is injected under the skin once a day until the patient has developed a suitable follicle, as assessed using ultrasound scans and by measuring blood oestrogen levels. This may take up to 5 weeks. The recommended starting dose is 150 International Units (IU) of follitropin alfa and 75 IU of lutropin alfa once a day, but this should be tailored to the patient’s response. Using less than the recommended starting dose may not be sufficient to stimulate development of a follicle. If necessary, the dose of follitropin alfa can be increased by adding it as a separate medicine, with 7 to 14 days between each dose increase.
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11690
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Pergoveris
Company	Merck Europe B.V.
Brand Description	Merck Europe B.V.
Prescribed For	Subcutaneous
Chemical Name	NA
Formulation	NA
Physical Appearance	The most common side effects reported with Pergoveris (seen in more than 1 patient in 10) are headache, ovarian cysts and injection site reactions (e.g. pain, itching, redness, bruising, swelling or irritation at the site of injection). Treatment can cause overstimulation of the ovaries (known as ovarian hyperstimulation syndrome, OHSS), which can lead to serious medical problems. Mild or moderate OHSS is common, while severe OHSS is uncommon. Thromboembolism (clots in the blood vessels) may occur very rarely, usually associated with severe OHSS.
Route of Administration	Pergoveris is a fertility medicine used in women to stimulate the development of follicles, the structures inside the ovaries that contain an egg.
Recommended Dosage	Pergoveris is available as a solution for injection in a pre-filled pen or as a powder and solvent to be made up into a solution for injection. Pergoveris is injected under the skin once a day until the patient has developed a suitable follicle, as assessed using ultrasound scans and by measuring blood oestrogen levels. This may take up to 5 weeks. The recommended starting dose is 150 International Units (IU) of follitropin alfa and 75 IU of lutropin alfa once a day, but this should be tailored to the patient’s response. Using less than the recommended starting dose may not be sufficient to stimulate development of a follicle. If necessary, the dose of follitropin alfa can be increased by adding it as a separate medicine, with 7 to 14 days between each dose increase.
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11691
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Pergoveris
Company	Merck Europe B.V.
Brand Description	Merck Europe B.V.
Prescribed For	Subcutaneous
Chemical Name	NA
Formulation	NA
Physical Appearance	The most common side effects reported with Pergoveris (seen in more than 1 patient in 10) are headache, ovarian cysts and injection site reactions (e.g. pain, itching, redness, bruising, swelling or irritation at the site of injection). Treatment can cause overstimulation of the ovaries (known as ovarian hyperstimulation syndrome, OHSS), which can lead to serious medical problems. Mild or moderate OHSS is common, while severe OHSS is uncommon. Thromboembolism (clots in the blood vessels) may occur very rarely, usually associated with severe OHSS.
Route of Administration	Pergoveris is a fertility medicine used in women to stimulate the development of follicles, the structures inside the ovaries that contain an egg.
Recommended Dosage	Pergoveris is available as a solution for injection in a pre-filled pen or as a powder and solvent to be made up into a solution for injection. Pergoveris is injected under the skin once a day until the patient has developed a suitable follicle, as assessed using ultrasound scans and by measuring blood oestrogen levels. This may take up to 5 weeks. The recommended starting dose is 150 International Units (IU) of follitropin alfa and 75 IU of lutropin alfa once a day, but this should be tailored to the patient’s response. Using less than the recommended starting dose may not be sufficient to stimulate development of a follicle. If necessary, the dose of follitropin alfa can be increased by adding it as a separate medicine, with 7 to 14 days between each dose increase.
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11692
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon
Company	Merck Ltd.
Brand Description	Merck Ltd.
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	50 unit / 0.5 mL
Formulation	NA
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11693
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon
Company	Merck Ltd.
Brand Description	Merck Ltd.
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	100 unit / 0.5 mL
Formulation	NA
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11694
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon
Company	Organon Canada Inc.
Brand Description	Organon Canada Inc.
Prescribed For	Subcutaneous
Chemical Name	833 unit / mL
Formulation	NA
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11695
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon
Company	N.V. Organon
Brand Description	N.V. Organon
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	50 IU/0.5mL
Formulation	NA
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11696
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon
Company	N.V. Organon
Brand Description	N.V. Organon
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	75 IU/0.5mL
Formulation	NA
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11697
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon
Company	N.V. Organon
Brand Description	N.V. Organon
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	100 IU/0.5mL
Formulation	NA
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11698
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon
Company	N.V. Organon
Brand Description	N.V. Organon
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	150 IU/0.5mL
Formulation	NA
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11699
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon
Company	N.V. Organon
Brand Description	N.V. Organon
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	200 IU/0.5mL
Formulation	NA
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11700
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon
Company	N.V. Organon
Brand Description	N.V. Organon
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	225 IU/0.5mL
Formulation	NA
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11701
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon
Company	N.V. Organon
Brand Description	N.V. Organon
Prescribed For	Subcutaneous
Chemical Name	300 IU/0.36mL
Formulation	NA
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11702
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon
Company	N.V. Organon
Brand Description	N.V. Organon
Prescribed For	Subcutaneous
Chemical Name	600 IU/0.72mL
Formulation	NA
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11703
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon
Company	N.V. Organon
Brand Description	N.V. Organon
Prescribed For	Subcutaneous
Chemical Name	150 IU/0.18mL
Formulation	NA
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11704
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon
Company	N.V. Organon
Brand Description	N.V. Organon
Prescribed For	Subcutaneous
Chemical Name	900 IU/1.08mL
Formulation	NA
Physical Appearance	Acid or sour stomach anxiety backache belching bloating chest pain or tightness confusion cough diarrhea difficulty breathing difficulty in speaking dizziness or lightheadedness double vision excess air or gas in the stomach or intestines fainting fast heartbeat fast, weak pulse full feeling headache heartburn inability to move the arms, legs, or facial muscles indigestion loss of appetite noisy breathing passing gas pelvic pain, discomfort, aching, or heaviness rapid weight gain severe nausea slow speech stomach discomfort, upset, or pain, or swelling sudden increase in stomach or shoulder pain sweating trouble breathing unusual or large amount of vaginal bleeding uterine bleeding between menstrual periods vomiting
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11705
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon (600 Iu)
Company	Organon Canada Ltd Ltee
Brand Description	Organon Canada Ltd Ltee
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	737 unit / cartridge
Formulation	NA
Physical Appearance	The most common side effects reported are a reaction and pain at the injection site. In 4% of the women treated with Puregon in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain and diarrhoea) have been reported. Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment.
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11706
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon 100 I.U.
Company	Organon Canada Ltd Ltee
Brand Description	Organon Canada Ltd Ltee
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	NA
Formulation	NA
Physical Appearance	The most common side effects reported are a reaction and pain at the injection site. In 4% of the women treated with Puregon in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain and diarrhoea) have been reported. Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment.
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11707
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Puregon 50 I.U.
Company	Organon Canada Ltd Ltee
Brand Description	Organon Canada Ltd Ltee
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	NA
Formulation	NA
Physical Appearance	The most common side effects reported are a reaction and pain at the injection site. In 4% of the women treated with Puregon in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain and diarrhoea) have been reported. Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment.
Route of Administration	Puregon is a powder and solvent to be made up into a solution for injection. It is also available as a solution for injection in a vial or a cartridge. Puregon contains the active substance follitropin beta.
Recommended Dosage	Puregon is used to treat infertility in women in the following situations:
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11708
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Rekovelle
Company	Ferring Pharmaceuticals
Brand Description	Ferring Pharmaceuticals
Prescribed For	Subcutaneous
Chemical Name	72 mcg / 2.16 mL
Formulation	NA
Physical Appearance	The most common side effects with Rekovelle (which may affect between 1 and 10 people in 100) are headache, discomfort and pain in the pelvic area which may arise from the ovaries, nausea (feeling sick) and tiredness and ovarian hyperstimulation syndrome (OHSS). OHSS is when a woman’s ovaries over-respond to stimulation, causing symptoms such as vomiting, diarrhoea and pain. In severe cases OHSS may lead to difficulty breathing and problems with blood clotting. The frequency of side effects may decrease with repeated treatment cycles. For the full list of all side effects reported with Rekovelle, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11709
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Rekovelle
Company	Ferring Pharmaceuticals
Brand Description	Ferring Pharmaceuticals
Prescribed For	Subcutaneous
Chemical Name	36 mcg / 1.08 mL
Formulation	NA
Physical Appearance	The most common side effects with Rekovelle (which may affect between 1 and 10 people in 100) are headache, discomfort and pain in the pelvic area which may arise from the ovaries, nausea (feeling sick) and tiredness and ovarian hyperstimulation syndrome (OHSS). OHSS is when a woman’s ovaries over-respond to stimulation, causing symptoms such as vomiting, diarrhoea and pain. In severe cases OHSS may lead to difficulty breathing and problems with blood clotting. The frequency of side effects may decrease with repeated treatment cycles. For the full list of all side effects reported with Rekovelle, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11710
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Rekovelle
Company	Ferring Pharmaceuticals
Brand Description	Ferring Pharmaceuticals
Prescribed For	Subcutaneous
Chemical Name	12 mcg / 0.36 mL
Formulation	NA
Physical Appearance	The most common side effects with Rekovelle (which may affect between 1 and 10 people in 100) are headache, discomfort and pain in the pelvic area which may arise from the ovaries, nausea (feeling sick) and tiredness and ovarian hyperstimulation syndrome (OHSS). OHSS is when a woman’s ovaries over-respond to stimulation, causing symptoms such as vomiting, diarrhoea and pain. In severe cases OHSS may lead to difficulty breathing and problems with blood clotting. The frequency of side effects may decrease with repeated treatment cycles. For the full list of all side effects reported with Rekovelle, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11711
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Rekovelle
Company	Ferring Pharmaceuticals
Brand Description	Ferring Pharmaceuticals
Prescribed For	Subcutaneous
Chemical Name	12 mcg /0.36ml
Formulation	NA
Physical Appearance	The most common side effects with Rekovelle (which may affect between 1 and 10 people in 100) are headache, discomfort and pain in the pelvic area which may arise from the ovaries, nausea (feeling sick) and tiredness and ovarian hyperstimulation syndrome (OHSS). OHSS is when a woman’s ovaries over-respond to stimulation, causing symptoms such as vomiting, diarrhoea and pain. In severe cases OHSS may lead to difficulty breathing and problems with blood clotting. The frequency of side effects may decrease with repeated treatment cycles. For the full list of all side effects reported with Rekovelle, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11712
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Rekovelle
Company	Ferring Pharmaceuticals
Brand Description	Ferring Pharmaceuticals
Prescribed For	Subcutaneous
Chemical Name	36 mcg /1.08ml
Formulation	NA
Physical Appearance	The most common side effects with Rekovelle (which may affect between 1 and 10 people in 100) are headache, discomfort and pain in the pelvic area which may arise from the ovaries, nausea (feeling sick) and tiredness and ovarian hyperstimulation syndrome (OHSS). OHSS is when a woman’s ovaries over-respond to stimulation, causing symptoms such as vomiting, diarrhoea and pain. In severe cases OHSS may lead to difficulty breathing and problems with blood clotting. The frequency of side effects may decrease with repeated treatment cycles. For the full list of all side effects reported with Rekovelle, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11713
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Rekovelle
Company	Ferring Pharmaceuticals
Brand Description	Ferring Pharmaceuticals
Prescribed For	Subcutaneous
Chemical Name	72 mcg /2.16ml
Formulation	NA
Physical Appearance	The most common side effects with Rekovelle (which may affect between 1 and 10 people in 100) are headache, discomfort and pain in the pelvic area which may arise from the ovaries, nausea (feeling sick) and tiredness and ovarian hyperstimulation syndrome (OHSS). OHSS is when a woman’s ovaries over-respond to stimulation, causing symptoms such as vomiting, diarrhoea and pain. In severe cases OHSS may lead to difficulty breathing and problems with blood clotting. The frequency of side effects may decrease with repeated treatment cycles. For the full list of all side effects reported with Rekovelle, see the package leaflet.
Route of Administration	NA
Recommended Dosage	NA
Contraindication	NA
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	11714
Therapeutic ID	Th1252
Protein Name	Follitropin
Sequence	>Th1252_Follitropin APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS
Molecular Weight	22672.9
Chemical Formula	C975H1513N267O304S26
Isoelectric Point	7.5
Hydrophobicity	-0.33
Melting point	55 °C
Half-life	Circulation half life of 3-4 hours, elimination half life of 35-40 hours
Description	Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.
Indication/Disease	In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamics	Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.
Mechanism of Action	Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.
Toxicity	Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.
Metabolism	NA
Absorption	The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.
	* 8 L [female subjects following intravenous administration of a 300 IU dose]
Clearance	* 0.01 1h-1kg-1 [European women with a single intramuscular dose of 300 IU] 0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Follicle-stimulating hormone receptor
Brand Name	Repronex
Company	Ferring Pharmaceuticals
Brand Description	Ferring Pharmaceuticals
Prescribed For	Intramuscular; Subcutaneous
Chemical Name	NA
Formulation	Repronex® (menotropins for injection) is contraindicated in women who have: A high FSH level indicating primary ovarian failure. Uncontrolled thyroid and adrenal dysfunction. An organic intracranial lesion such as a pituitary tumor. The presence of any cause of infertility other than anovulation unless they are candidates for in vitro-fertilization. Abnormal bleeding of undetermined origin. Ovarian cysts or enlargement not due to polycystic ovary syndrome. Prior hypersensitivity to menotropins. Repronex® (menotropins for injection) is not indicated in women who are pregnant. There are limited human data on the effects of menotropins when administered during pregnancy.
Physical Appearance	headache mild stomach pain bloating injection site reactions (redness, pain, swelling, or irritation) breast tenderness or enlargement dizziness ovarian enlargement (abdominal or pelvic pain, tenderness, pressure, or swelling) nausea vomiting diarrhea shortness of breath pain/warmth/tenderness centralized in an arm or leg fever chills drowsiness weakness or aching of muscles or joints, or rash
Route of Administration	Menotropins injection is used to treat infertility in women. Menotropins are a mixture of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) that are produced in the body by the pituitary gland. Menotropins injection is used in women with healthy ovaries who are enrolled in a fertility program...
Recommended Dosage	Repronex is a prescription medicine used to treat the symptoms of Ovulation Induction, Assisted Reproductive Technology (ART), and Spermatogenesis. Repronex may be used alone or with other medications.
Contraindication	NA
Side Effects	FOR SUBCUTANEOUS INJECTION AND INTRAMUSCULAR INJECTION
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA