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Th1607 details

Primary information
ID	15545
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	Blood Coagulation Factors
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Coagulation factor VIII
Brand Name	Jivi
Company	Bayer
Brand Description	Bayer
Prescribed For	Intravenous
Chemical Name	250 unit / vial
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	15546
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	Pegylated agents
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	Coagulation factor VIII
Brand Name	Jivi
Company	Bayer
Brand Description	Bayer
Prescribed For	Intravenous
Chemical Name	500 unit / vial
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	15547
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	NA
Brand Name	Jivi
Company	Bayer Ag
Brand Description	Bayer Ag
Prescribed For	Intravenous
Chemical Name	250 IU
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	15548
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	NA
Brand Name	Jivi
Company	Bayer
Brand Description	Bayer
Prescribed For	Intravenous
Chemical Name	1000 unit / vial
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	15549
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	NA
Brand Name	Jivi
Company	Bayer
Brand Description	Bayer
Prescribed For	Intravenous
Chemical Name	2000 unit / vial
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	15550
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	NA
Brand Name	Jivi
Company	Bayer Ag
Brand Description	Bayer Ag
Prescribed For	Intravenous
Chemical Name	500 IU
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	15551
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	NA
Brand Name	Jivi
Company	Bayer
Brand Description	Bayer
Prescribed For	Intravenous
Chemical Name	3000 unit / vial
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	15552
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	NA
Brand Name	Jivi
Company	Bayer Ag
Brand Description	Bayer Ag
Prescribed For	Intravenous
Chemical Name	1000 IU
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	15553
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	NA
Brand Name	Jivi
Company	Bayer Ag
Brand Description	Bayer Ag
Prescribed For	Intravenous
Chemical Name	2000 IU
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	15554
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	NA
Brand Name	Jivi
Company	Bayer Ag
Brand Description	Bayer Ag
Prescribed For	Intravenous
Chemical Name	3000 IU
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	15555
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	NA
Brand Name	Jivi
Company	Bayer HealthCare LLC
Brand Description	Bayer HealthCare LLC
Prescribed For	Intravenous
Chemical Name	500 [iU]/2.5mL
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	15556
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	NA
Brand Name	Jivi
Company	Bayer HealthCare LLC
Brand Description	Bayer HealthCare LLC
Prescribed For	Intravenous
Chemical Name	1000 [iU]/2.5mL
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	15557
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	NA
Brand Name	Jivi
Company	Bayer HealthCare LLC
Brand Description	Bayer HealthCare LLC
Prescribed For	Intravenous
Chemical Name	2000 [iU]/5mL
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA

Primary information
ID	15558
Therapeutic ID	Th1607
Protein Name	Damoctocog alfa pegol
Sequence	>Th1607_Damoctocog_alfa_pegol ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNPPVLKRHQREITRTTLQSDQEEIDYDDTISVEMKKEDFDIYDEDENQSPRSFQKKTRHYFIAAVERLWDYGMSSSPHVLRNRAQSGSVPQFKKVVFQEFTDGSFTQPLYRGELNEHLGLLGPYIRAEVEDNIMVTFRNQASRPYSFYSSLISYEEDQRQGAEPRCNFVKPNETKTYFWKVQHHMAPTKDEFDCKAWAYFSDVDLEKDVHSGLIGPLLVCHTNTLNPAHGRQVTVQEFALFFTIFDETKSWYFTENMERNCRAPCNIQMEDPTFKENYRFHAINGYIMDTLPGLVMAQDQRIRWYLLSMGSNENIHSIHFSGHVFTVRKKEEYKMALYNLYPGVFETVEMLPSKAGIWRVECLIGEHLHAGMSTLFLVYSNKCQTPLGMASGHIRDFQITASGQYGQWAPKLARLHYSGSINAWSTKEPFSWIKVDLLAPMIIHGIKTQGARQKFSSLYISQFIIMYSLDGKKWQTYRGNSTGTLMVFFGNVDSSGIKHNIFNPPIIARYIRLHPTHYSIRSTLRMELMGCDLNSCSMPLGMESKAISDAQITASSYFTNMFATWSPSKARLHLQGRSNAWRPQVNNPKEWLQVDFQKTMKVTGVTTQGVKSLLTSMYVKEFLISSSQDGHQWTLFFQNGKVKVFQGNQDSFTPVVNSLDPPLLTRYLRIHPQSWVHQIALRMEVLGCEAQDLY
Molecular Weight	234
Chemical Formula	NA
Isoelectric Point	NA
Hydrophobicity	NA
Melting point	NA
Half-life	18.6 ± 4.6h after a single dose [FDA label]
Description	In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized.[A38907] Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A.[L4576,A38909,Label] This product has been engineered by Bayer[L4576] and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.[F1609]
Indication/Disease	Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes [FDA label], perioperative management of bleeding [FDA label], and routine prophylaxis to reduce the frequency of bleeding episodes [FDA label].
Pharmacodynamics	This agent is engineered to prolong blood FVIII activity while maintaining coagulation activity using PEGylation, where a PEG (Polyethylene glycol) molecule is continually attached to the factor VIII protein at a specific site [L4576], [A38909]. This prevents and controls bleeding episodes associated with hemophilia A. The aPTT is prolonged in people diagnosed with hemophilia A. The determination of aPTT is a conventional in vitro assay for assessing the biological activity of Factor VIII. Treatment with damoctogog alfa pegol normalizes the aPTT similar to that achieved with plasma-derived Factor VIII. The administration of this agent increases plasma levels of Factor VIII and can temporarily correct the coagulation defect that exists in hemophilia A patients [FDA label].
Mechanism of Action	This drug is a site-specifically PEGylated recombinant antihemophilic factor, which temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in a longer half-life and increased AUC (area under the curve) [FDA label]. The active protein, prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells [FDA label]. Damoctagol alfa pegol is manufactured by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was identified and selected for conjugation to provide both a continual coagulation activity and high PEGylation efficiency [FDA label].
Toxicity	The most commonly reported adverse reactions in clinical trials in previously treated patients (PTPs) = 12 years of age (= 5%) were headache, cough, nausea, and fever [FDA label]. Hypersensitivity reactions, which includes severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, stop treatment with this agent and administer appropriate supportive treatment. Hypersensitivity reactions may also be related to antibodies targeted against polyethylene glycol (PEG) [FDA label]. Development of Factor VIII neutralizing antibodies can also occur. If expected plasma Factor VIII activity levels are not reached, or if bleeding is not controlled as expected with the administered dose, perform an assay that quantifies Factor VIII inhibitor concentration [FDA label]. Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed mainly in subjects less than 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or impaired recovery [FDA label].
Metabolism	NA
Absorption	After a single dose, AUC (area under the curve) was 1640 ± 550 [FDA label] with a dose of 25 IU/kg.
	NA
Clearance	142 ± 33 mL/h on with a dose of 25 IU/kg and 121 ± 53 mL/h with a dose of 60 IU/kg [FDA label].
Categories	NA
Patents Number	NA
Date of Issue	NA
Date of Expiry	NA
Drug Interaction	NA
Target	NA
Brand Name	Jivi
Company	Bayer HealthCare LLC
Brand Description	Bayer HealthCare LLC
Prescribed For	Intravenous
Chemical Name	3000 [iU]/2.5mL
Formulation	Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product [see DESCRIPTION].
Physical Appearance	headache, cough, nausea, fever, vomiting, abdominal pain, rash, hypersensitivity reactions, insomnia, injection site reactions (itching and rash), dizziness, skin redness, itching, flushing, and distorted sense of taste
Route of Administration	Jivi (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood. Recombinant Jivi is used to treat or prevent bleeding episodes in adults and children with hemophilia...
Recommended Dosage	Jivi, antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
Contraindication	(2R)-2-amino-3-[1-[3-[3-[2,3-bis(2-methoxyethoxy)propoxy]propylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Side Effects	NA
Useful Link 1	Link
Useful Link 2	Link
Remarks	NA