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Th1256 details
Primary information
ID11760
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesBlood Coagulation Factors
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionAminocaproic acid,Alpha-1-proteinase inhibitor,Menadione,Tranexamic acid,Aprotinin,Hydrogen peroxide,Aminomethylbenzoic acid,Camostat,Menadione bisulfite,Monteplase,Lepirudin,Bivalirudin,Alteplase,Urokinase,Reteplase,Anistreplase,Tenecteplase,Abciximab,Drotrecogin alfa,Streptokinase,Dicoumarol,Argatroban,Ardeparin,Phenindione,Fondaparinux,Warfarin,Pentosan polysulfate,Phenprocoumon,Dipyridamole,Heparin,Enoxaparin,Epoprostenol,Acenocoumarol,4-hydroxycoumarin,Coumarin,Ximelagatran,Desmoteplase,Defibrotide,Ancrod,Beraprost,Fibrinolysin,Prasugrel,Rivaroxaban,Sulodexide,Idraparinux,Cangrelor,Astaxanthin,Apixaban,Otamixaban,Amediplase,Dabigatran etexilate,Danaparoid,Dalteparin,Tinzaparin,Ferulic acid,(R)-warfarin,Ethyl biscoumacetate,Nadroparin,Triflusal,Ticagrelor,Ditazole,Vorapaxar,Edoxaban,Potassium citrate,Sodium citrate,Dextran,Bemiparin,Parnaparin,Desirudin,Zinc citrate,Antithrombin Alfa,Protein C,Antithrombin III human,Letaxaban,Darexaban,Betrixaban,Nafamostat,Gabexate,Fluindione,Protein S human,Brinase,Clorindione,Diphenadione,Tioclomarol,Melagatran,Saruplase,(S)-Warfarin,Tocopherylquinone,Edetate calcium disodium anhydrous,Dabigatran,Semuloparin,Troxerutin,Edetic acid,Reviparin,Dermatan sulfate,SR-123781A,Dociparstat sodium
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBeneFIX
CompanyWyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
Brand DescriptionWyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
Prescribed ForIntravenous; Topical
Chemical NameNA
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11761
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesHemostatics
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBeneFIX
CompanyWyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Brand DescriptionWyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Prescribed ForIntravenous; Topical
Chemical NameNA
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11762
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesIncreased Coagulation Activity
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBeneFIX
CompanyPfizer Canada Ulc
Brand DescriptionPfizer Canada Ulc
Prescribed ForIntravenous
Chemical Name250 unit / vial
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11763
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBeneFIX
CompanyPfizer Canada Ulc
Brand DescriptionPfizer Canada Ulc
Prescribed ForIntravenous
Chemical Name500 unit / vial
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11764
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBeneFIX
CompanyPfizer Canada Ulc
Brand DescriptionPfizer Canada Ulc
Prescribed ForIntravenous
Chemical Name1000 unit / vial
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11765
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBeneFIX
CompanyPfizer Canada Ulc
Brand DescriptionPfizer Canada Ulc
Prescribed ForIntravenous
Chemical Name2000 unit / vial
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11766
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBeneFIX
CompanyPfizer Canada Ulc
Brand DescriptionPfizer Canada Ulc
Prescribed ForIntravenous
Chemical Name3000 unit / vial
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11767
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBeneFIX
CompanyPfizer Canada Ulc
Brand DescriptionPfizer Canada Ulc
Prescribed ForIntravenous
Chemical Name1500 unit / vial
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11768
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBenefix
CompanyPfizer Europe Ma Eeig
Brand DescriptionPfizer Europe Ma Eeig
Prescribed ForIntravenous
Chemical Name250 IU
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11769
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBenefix
CompanyPfizer Europe Ma Eeig
Brand DescriptionPfizer Europe Ma Eeig
Prescribed ForIntravenous
Chemical Name500 IU
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11770
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBenefix
CompanyPfizer Europe Ma Eeig
Brand DescriptionPfizer Europe Ma Eeig
Prescribed ForIntravenous
Chemical Name1000 IU
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11771
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBenefix
CompanyPfizer Europe Ma Eeig
Brand DescriptionPfizer Europe Ma Eeig
Prescribed ForIntravenous
Chemical Name2000 IU
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11772
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBenefix
CompanyPfizer Europe Ma Eeig
Brand DescriptionPfizer Europe Ma Eeig
Prescribed ForIntravenous
Chemical Name3000 IU
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11773
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBenefix
CompanyPfizer Europe Ma Eeig
Brand DescriptionPfizer Europe Ma Eeig
Prescribed ForIntravenous
Chemical Name1500 IU
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance fever, injection site reactions (pain, redness, or swelling), chills, headache, flushing (warmth, redness, or tingly feeling under your skin), weakness, nausea, vomiting, or dizziness
Route of AdministrationBeneFIX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. BeneFIX may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageBeneFIX is a prescription medicine used to treat the symptoms of Bleeding Episodes associated with Hemophilia B and as Routine Prophylaxis to Hemophilia B. BeneFIX may be used alone or with other medications.
ContraindicationNA
Side EffectsCoagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11774
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBenefix - (250iu)
CompanyWyeth Ltd.
Brand DescriptionWyeth Ltd.
Prescribed ForIntravenous
Chemical NameNA
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance hives, difficulty breathing, swelling of your face, lips, tongue, or throat, itching, wheezing, tightness in your chest, fast heartbeats, blue lips, lightheadedness, weight gain, swelling in your waist, hands, or lower legs, loss of appetite, fever, chills, continued bleeding after treatment, new or worsening bleeding, sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance, chest pain, coughing up blood, and pain, swelling, warmth and redness in one or both legs
Route of AdministrationBeneFIX is a medicine that contains the active substance nonacog alfa. It is available as a powder and solvent that are mixed together to form a solution for injection.
Recommended DosageBeneFIX is used for the treatment and prevention of bleeding in adults and children with haemophilia B (an inherited bleeding disorder). BeneFIX is intended for either short-term or long-term use.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11775
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBenefix - (500iu)
CompanyWyeth Ltd.
Brand DescriptionWyeth Ltd.
Prescribed ForIntravenous
Chemical NameNA
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance hives, difficulty breathing, swelling of your face, lips, tongue, or throat, itching, wheezing, tightness in your chest, fast heartbeats, blue lips, lightheadedness, weight gain, swelling in your waist, hands, or lower legs, loss of appetite, fever, chills, continued bleeding after treatment, new or worsening bleeding, sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance, chest pain, coughing up blood, and pain, swelling, warmth and redness in one or both legs
Route of AdministrationBeneFIX is a medicine that contains the active substance nonacog alfa. It is available as a powder and solvent that are mixed together to form a solution for injection.
Recommended DosageBeneFIX is used for the treatment and prevention of bleeding in adults and children with haemophilia B (an inherited bleeding disorder). BeneFIX is intended for either short-term or long-term use.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11776
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameBenefix -(1000iu)
CompanyWyeth Ltd.
Brand DescriptionWyeth Ltd.
Prescribed ForIntravenous
Chemical NameNA
FormulationBeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Physical Appearance hives, difficulty breathing, swelling of your face, lips, tongue, or throat, itching, wheezing, tightness in your chest, fast heartbeats, blue lips, lightheadedness, weight gain, swelling in your waist, hands, or lower legs, loss of appetite, fever, chills, continued bleeding after treatment, new or worsening bleeding, sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance, chest pain, coughing up blood, and pain, swelling, warmth and redness in one or both legs
Route of AdministrationBeneFIX is a medicine that contains the active substance nonacog alfa. It is available as a powder and solvent that are mixed together to form a solution for injection.
Recommended DosageBeneFIX is used for the treatment and prevention of bleeding in adults and children with haemophilia B (an inherited bleeding disorder). BeneFIX is intended for either short-term or long-term use.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11777
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIdelvion
CompanyCsl Behring
Brand DescriptionCsl Behring
Prescribed ForIntravenous
Chemical Name500 IU/1
FormulationIDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), is contraindicated in patients who have a known hypersensitivity to IDELVION, any of its components, excipients or hamster protein. For a complete listing, see Dosage Forms, Composition And Packaging.
Physical Appearance headache, dizziness, rash, and infusion site reaction
Route of AdministrationIdelvion is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Idelvion may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIdelvion is a prescription medicine used as prophylaxis and to treat the symptoms of Hemophilia B. Idelvion may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11778
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIdelvion
CompanyCsl Behring
Brand DescriptionCsl Behring
Prescribed ForIntravenous
Chemical Name1000 IU/1
FormulationIDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), is contraindicated in patients who have a known hypersensitivity to IDELVION, any of its components, excipients or hamster protein. For a complete listing, see Dosage Forms, Composition And Packaging.
Physical Appearance headache, dizziness, rash, and infusion site reaction
Route of AdministrationIdelvion is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Idelvion may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIdelvion is a prescription medicine used as prophylaxis and to treat the symptoms of Hemophilia B. Idelvion may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11779
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIdelvion
CompanyCsl Behring
Brand DescriptionCsl Behring
Prescribed ForIntravenous
Chemical Name2000 IU/1
FormulationIDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), is contraindicated in patients who have a known hypersensitivity to IDELVION, any of its components, excipients or hamster protein. For a complete listing, see Dosage Forms, Composition And Packaging.
Physical Appearance headache, dizziness, rash, and infusion site reaction
Route of AdministrationIdelvion is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Idelvion may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIdelvion is a prescription medicine used as prophylaxis and to treat the symptoms of Hemophilia B. Idelvion may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11780
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyCangene Biopharma
Brand DescriptionCangene Biopharma
Prescribed ForIntravenous
Chemical Name2000 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11781
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyCangene Biopharma
Brand DescriptionCangene Biopharma
Prescribed ForIntravenous
Chemical Name3000 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11782
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyAptevo Biotherapeutics Llc
Brand DescriptionAptevo Biotherapeutics Llc
Prescribed ForIntravenous
Chemical Name1000 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11783
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyAptevo Biotherapeutics Llc
Brand DescriptionAptevo Biotherapeutics Llc
Prescribed ForIntravenous
Chemical Name1500 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11784
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyAptevo Biotherapeutics Llc
Brand DescriptionAptevo Biotherapeutics Llc
Prescribed ForIntravenous
Chemical Name250 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11785
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyAptevo Biotherapeutics Llc
Brand DescriptionAptevo Biotherapeutics Llc
Prescribed ForIntravenous
Chemical Name500 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11786
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyAptevo Biotherapeutics Llc
Brand DescriptionAptevo Biotherapeutics Llc
Prescribed ForIntravenous
Chemical Name2000 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11787
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyAptevo Biotherapeutics Llc
Brand DescriptionAptevo Biotherapeutics Llc
Prescribed ForIntravenous
Chemical Name3000 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11788
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyCangene Biopharma
Brand DescriptionCangene Biopharma
Prescribed ForIntravenous
Chemical Name500 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11789
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyCangene Biopharma
Brand DescriptionCangene Biopharma
Prescribed ForIntravenous
Chemical Name1000 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11790
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyCangene Biopharma
Brand DescriptionCangene Biopharma
Prescribed ForIntravenous
Chemical Name1500 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11791
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyMedexus Pharma, Inc.
Brand DescriptionMedexus Pharma, Inc.
Prescribed ForIntravenous
Chemical Name250 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11792
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyMedexus Pharma, Inc.
Brand DescriptionMedexus Pharma, Inc.
Prescribed ForIntravenous
Chemical Name500 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11793
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyMedexus Pharma, Inc.
Brand DescriptionMedexus Pharma, Inc.
Prescribed ForIntravenous
Chemical Name1000 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11794
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyMedexus Pharma, Inc.
Brand DescriptionMedexus Pharma, Inc.
Prescribed ForIntravenous
Chemical Name1500 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11795
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyMedexus Pharma, Inc.
Brand DescriptionMedexus Pharma, Inc.
Prescribed ForIntravenous
Chemical Name2000 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11796
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameIxinity
CompanyMedexus Pharma, Inc.
Brand DescriptionMedexus Pharma, Inc.
Prescribed ForIntravenous
Chemical Name3000 [iU]/5mL
FormulationIXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see WARNINGS AND PRECAUTIONS].
Physical Appearance headache, allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath), injection site discomfort, weakness or lack of energy, influenza, changes in taste, apathy, depression, or itchy rash.
Route of AdministrationIxinity is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Ixinity may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageIxinity is a prescription medicine used to treat the symptoms of and as a prophylaxis for Hemophilia B and to treat Bleeding Episodes. Ixinity may be used alone or with other medications.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11797
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRebinyn
CompanyNovo Nordisk
Brand DescriptionNovo Nordisk
Prescribed ForIntravenous
Chemical Name500 [iU]/1mL
FormulationREBINYN is contraindicated in patients who have known hypersensitivity to REBINYN or its components (including hamster proteins) [see WARNINGS AND PRECAUTIONS and DESCRIPTION]
Physical Appearance itching, injection site reactions, and hypersensitivity reactions.
Route of AdministrationRebinyn is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rebinyn may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageREBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation
ContraindicationNA
Side EffectsThese are not all of the possible side effects from REBINYN. Ask your healthcare provider for more information. You are encouraged to report side effects to FDA at 1-800-FDA-1088.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11798
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRebinyn
CompanyNovo Nordisk
Brand DescriptionNovo Nordisk
Prescribed ForIntravenous
Chemical Name1000 [iU]/1mL
FormulationREBINYN is contraindicated in patients who have known hypersensitivity to REBINYN or its components (including hamster proteins) [see WARNINGS AND PRECAUTIONS and DESCRIPTION]
Physical Appearance itching, injection site reactions, and hypersensitivity reactions.
Route of AdministrationRebinyn is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rebinyn may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageREBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation
ContraindicationNA
Side EffectsThese are not all of the possible side effects from REBINYN. Ask your healthcare provider for more information. You are encouraged to report side effects to FDA at 1-800-FDA-1088.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11799
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRebinyn
CompanyNovo Nordisk
Brand DescriptionNovo Nordisk
Prescribed ForIntravenous
Chemical Name2000 [iU]/1mL
FormulationREBINYN is contraindicated in patients who have known hypersensitivity to REBINYN or its components (including hamster proteins) [see WARNINGS AND PRECAUTIONS and DESCRIPTION]
Physical Appearance itching, injection site reactions, and hypersensitivity reactions.
Route of AdministrationRebinyn is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rebinyn may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageREBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation
ContraindicationNA
Side EffectsThese are not all of the possible side effects from REBINYN. Ask your healthcare provider for more information. You are encouraged to report side effects to FDA at 1-800-FDA-1088.
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11800
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyBaxalta US Inc.
Brand DescriptionBaxalta US Inc.
Prescribed ForIntravenous
Chemical Name250 [iU]/5mL
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11801
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyBaxalta US Inc.
Brand DescriptionBaxalta US Inc.
Prescribed ForIntravenous
Chemical Name500 [iU]/5mL
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11802
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyBaxalta US Inc.
Brand DescriptionBaxalta US Inc.
Prescribed ForIntravenous
Chemical Name1000 [iU]/5mL
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11803
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyBaxalta US Inc.
Brand DescriptionBaxalta US Inc.
Prescribed ForIntravenous
Chemical Name2000 [iU]/5mL
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11804
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyBaxalta US Inc.
Brand DescriptionBaxalta US Inc.
Prescribed ForIntravenous
Chemical Name3000 [iU]/5mL
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11805
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyTakeda
Brand DescriptionTakeda
Prescribed ForIntravenous
Chemical Name500 unit / vial
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11806
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyTakeda
Brand DescriptionTakeda
Prescribed ForIntravenous
Chemical Name1000 unit / vial
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11807
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyTakeda
Brand DescriptionTakeda
Prescribed ForIntravenous
Chemical Name2000 unit / vial
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11808
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyTakeda
Brand DescriptionTakeda
Prescribed ForIntravenous
Chemical Name250 unit / vial
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11809
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyTakeda
Brand DescriptionTakeda
Prescribed ForIntravenous
Chemical Name3000 unit / vial
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11810
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyBaxalta Innovations Gmb H
Brand DescriptionBaxalta Innovations Gmb H
Prescribed ForIntravenous
Chemical Name250 IU
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11811
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyBaxalta Innovations Gmb H
Brand DescriptionBaxalta Innovations Gmb H
Prescribed ForIntravenous
Chemical Name500 IU
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11812
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyBaxalta Innovations Gmb H
Brand DescriptionBaxalta Innovations Gmb H
Prescribed ForIntravenous
Chemical Name1000 IU
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11813
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyBaxalta Innovations Gmb H
Brand DescriptionBaxalta Innovations Gmb H
Prescribed ForIntravenous
Chemical Name2000 IU
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID11814
Therapeutic IDTh1256
Protein NameCoagulation Factor IX (Recombinant)
Sequence>Th1256_Coagulation_Factor_IX_(Recombinant) YNSGKLEEFVQGNLERECMEEKCSFEEAREVFENTERTTEFWKQYVDGDQCESNPCLNGGSCKDDINSYECWCPFGFEGKNCELDVTCNIKNGRCEQFCKNSADNKVVCSCTEGYRLAENQKSCEPAVPFPCGRVSVSQTSKLTRAEAVFPDVDYVNSTEAETILDNITQSTQSFNDFTRVVGGEDAKPGQFPWQVVLNGKVDAFCGGSIVNEKWIVTAAHCVETGVKITVVAGEHNIEETEHTEQKRNVIRIIPHHNYNAAINKYNHDIALLELDEPLVLNSYVTPICIADKEYTNIFLKFGSGYVSGWGRVFHKGRSALVLQYLRVPLVDRATCLRSTKFTIYNNMFCAGFHEGGRDSCQGDSGGPHVTEVEGTSFLTGIISWGEECAMKGKYGIYTKVSRYVNWIKEKTKLT
Molecular Weight46548.2
Chemical FormulaC2041H3136N558O641S25
Isoelectric Point5.2
Hydrophobicity-0.431
Melting point54 °C
Half-life18.8 ± 5.4 hours
DescriptionRecombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication/DiseaseFor treatment of hemophilia (Christmas disease).
PharmacodynamicsBinds vitamin K and factor VIIIa. Cleaves the Arg-Ile bond in factor X to form active factor Xa. Plays a key role in blood coagulation and clotting. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. AlphaNine is injected to increase plasma levels of Factor IX and can temporarily correct this coagulation defect. The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.
Mechanism of ActionCoagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
Clearance8.62 ± 1.7
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCoagulation factor X,Coagulation factor XI,Coagulation factor VII,Coagulation factor VIII,Prothrombin,Prolow-density lipoprotein receptor-related protein 1,Vitamin K-dependent gamma-carboxylase
Brand NameRixubis
CompanyBaxalta Innovations Gmb H
Brand DescriptionBaxalta Innovations Gmb H
Prescribed ForIntravenous
Chemical Name3000 IU
FormulationRIXUBIS is contraindicated in patients who have:Known hypersensitivity to RIXUBIS or its excipients including hamster proteinDisseminated Intravascular Coagulation (DIC) [see WARNINGS AND PRECAUTIONS]Signs of fibrinolysis [see WARNINGS AND PRECAUTIONS]
Physical Appearance The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.
Route of AdministrationRixubis is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency. Rixubis may also be used for purposes not listed in this medication guide. Warnings Follow all directions on your medicine label and package....
Recommended DosageRixubis is a prescription medicine used to treat the symptoms of Hemophilia B, Bleeding Episodes and as a prophylaxis. Rixubis may be used alone or with other medications.
ContraindicationNA
Side EffectsRIXUBIS is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units. Each vial contains nominally 250, 500, 1000, 2000 or 3000 international units of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
Useful Link 1Link
Useful Link 2Link
RemarksNA