Coagulation Factor IX (Recombinant)
- Generic Name
- Coagulation Factor IX (Recombinant)
- Brand Names
- Benefix, Idelvion, Ixinity, Rixubis, BeneFIX
- Drug Type
- Biotech
- CAS Number
- 181054-95-5
- Unique Ingredient Identifier
- 382L14738L
Overview
Recombinant 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).
Background
Recombinant 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
For treatment of hemophilia (Christmas disease).
Associated Conditions
- Bleeding
- Hemophilia B
- Perioperative bleeding caused by Hemophilia B
Clinical Trials
FDA Approved Products
Singapore Approved Products
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