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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

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
BENEFIX factor IX recombinant 1000 IU powder for injection vial and diluent syringe composite pack
128377
Medicine
A
9/27/2007
Rixubis nonacog gamma (rch) 2000 IU powder and solvent for solution for injection glass vials
204768
Medicine
A
2/5/2014
BENEFIX factor IX recombinant 500 IU powder for injection vial and diluent syringe composite pack
128375
Medicine
A
9/27/2007
Rixubis nonacog gamma (rch) 3000 IU powder and solvent for solution for injection glass vials
204765
Medicine
A
2/5/2014
BENEFIX factor IX recombinant 3000 IU powder for injection vial and diluent syringe composite pack
203316
Medicine
A
8/20/2013
BENEFIX factor IX recombinant 250 IU powder for injection vial and diluent syringe composite pack
128339
Medicine
A
9/27/2007
Rixubis nonacog gamma (rch) 500 IU powder and solvent for solution for injection glass vials
204769
Medicine
A
2/5/2014
Rixubis nonacog gamma (rch) 1000 IU powder and solvent for solution for injection glass vials
204766
Medicine
A
2/5/2014
Rixubis nonacog gamma (rch) 250 IU powder and solvent for solution for injection glass vials
204767
Medicine
A
2/5/2014
BENEFIX factor IX recombinant 2000 IU powder for injection vial and diluent syringe composite pack
128378
Medicine
A
9/27/2007
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