Coagulation Factor IX (Recombinant)

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).

Indication

For treatment of hemophilia (Christmas disease).

Associated Conditions

Bleeding
Hemophilia B
Perioperative bleeding caused by Hemophilia B

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy and Safety of AlphaNine Versus BeneFIX in Patients With Severe Hereditary Haemophilia B	2017/03/27	NCT03091751	Phase 2	Completed	Grifols Biologicals, LLC
Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China	2015/01/12	NCT02336178	Phase 4	Completed	Pfizer
An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B	2014/08/11	NCT02213250	Phase 1	Completed	Pfizer
Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B	2009/12/07	NCT01027364	Phase 3	Completed	Bioverativ Therapeutics Inc.
Registry For Patients Treated With BeneFix In Usual Care Setting In Germany	2008/07/14	NCT00714415	N/A	Completed	Pfizer
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B	2007/06/08	NCT00484185	N/A	Completed	Pfizer
Study Evaluating rFIX; BeneFIX® in Hemophilia B	2004/10/07	NCT00093171	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer
Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B	2004/10/07	NCT00093210	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer
Study Evaluating rFIX; BeneFIX in Severe Hemophilia B	2002/05/20	NCT00037557	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer

FDA Drug Approvals

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

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Rixubis	Baxalta Innovations GmbH,Industriestrasse 67,1221 Vienna,Austria	Authorised	12/19/2014
BeneFIX	Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium	Authorised	8/27/1997

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
BeneFIX Powder and Solvent for Solution for Injection 500iu/vial	(Diluent) Vetter Pharma-Fertigung GmbH & Co. KG, Wyeth Farma S.A, Vetter Pharma-Fertigung GmbH & Co. KG (Manufacturer of diluent)	SIN13804P	INJECTION, POWDER, FOR SOLUTION	500IU/vial(138IU/mL)	5/20/2010
BeneFIX Powder and Solvent for Solution for Injection 2000iu/vial	(Diluent) Vetter Pharma-Fertigung GmbH & Co. KG, Wyeth Farma S.A, Vetter Pharma-Fertigung GmbH & Co. KG (Manufacturer of diluent)	SIN13806P	INJECTION, POWDER, FOR SOLUTION	2000IU/vial(550IU/mL)	5/20/2010
BeneFIX Powder and Solvent for Solution for Injection 1000iu/vial	(Diluent) Vetter Pharma-Fertigung GmbH & Co. KG, Wyeth Farma S.A, Vetter Pharma-Fertigung GmbH & Co. KG (Manufacturer of diluent)	SIN13805P	INJECTION, POWDER, FOR SOLUTION	1000IU/vial(275IU/mL)	5/20/2010
BeneFIX Powder and Solvent for Solution for Injection 250iu/vial	(Diluent) Vetter Pharma-Fertigung GmbH & Co. KG, Wyeth Farma S.A, Vetter Pharma-Fertigung GmbH & Co. KG (Manufacturer of diluent)	SIN13803P	INJECTION, POWDER, FOR SOLUTION	250IU/vial (69IU/mL)	5/20/2010

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	Pfizer Australia Pty Ltd	Medicine	A	9/27/2007
Rixubis nonacog gamma (rch) 2000 IU powder and solvent for solution for injection glass vials	204768	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	2/5/2014
BENEFIX factor IX recombinant 500 IU powder for injection vial and diluent syringe composite pack	128375	Pfizer Australia Pty Ltd	Medicine	A	9/27/2007
Rixubis nonacog gamma (rch) 3000 IU powder and solvent for solution for injection glass vials	204765	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	2/5/2014
BENEFIX factor IX recombinant 3000 IU powder for injection vial and diluent syringe composite pack	203316	Pfizer Australia Pty Ltd	Medicine	A	8/20/2013
BENEFIX factor IX recombinant 250 IU powder for injection vial and diluent syringe composite pack	128339	Pfizer Australia Pty Ltd	Medicine	A	9/27/2007
Rixubis nonacog gamma (rch) 500 IU powder and solvent for solution for injection glass vials	204769	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	2/5/2014
Rixubis nonacog gamma (rch) 1000 IU powder and solvent for solution for injection glass vials	204766	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	2/5/2014
Rixubis nonacog gamma (rch) 250 IU powder and solvent for solution for injection glass vials	204767	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	2/5/2014
BENEFIX factor IX recombinant 2000 IU powder for injection vial and diluent syringe composite pack	128378	Pfizer Australia Pty Ltd	Medicine	A	9/27/2007

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
RIXUBIS	takeda canada inc	02431963	Kit , Powder For Solution - Intravenous	3000 UNIT / VIAL	9/25/2018
BENEFIX	Pfizer Canada Ulc	02392984	Powder For Solution - Intravenous	3000 UNIT / VIAL	2/12/2013
RIXUBIS	takeda canada inc	02431947	Kit , Powder For Solution - Intravenous	1000 UNIT / VIAL	4/18/2017
BENEFIX - (250IU)	wyeth canada	02231018	Kit , Powder For Solution , Liquid - Intravenous	250 UNIT / VIAL	8/12/1998
RIXUBIS	takeda canada inc	02431955	Kit , Powder For Solution - Intravenous	2000 UNIT / VIAL	4/18/2017
BENEFIX	Pfizer Canada Ulc	02293803	Powder For Solution - Intravenous	2000 UNIT / VIAL	7/12/2008
BENEFIX	Pfizer Canada Ulc	02466619	Powder For Solution - Intravenous	1500 UNIT / VIAL	N/A
BENEFIX - (500IU)	wyeth canada	02231019	Kit , Powder For Solution , Liquid - Intravenous	500 UNIT / VIAL	8/12/1998
BENEFIX	Pfizer Canada Ulc	02293781	Powder For Solution - Intravenous	1000 UNIT / VIAL	4/14/2007
BENEFIX -(1000IU)	wyeth canada	02231020	Powder For Solution , Liquid , Kit - Intravenous	1000 UNIT / VIAL	8/12/1998

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
BENEFIX 3000 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Pfizer Europe Ma Eeig	197047008	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
Rixubis 250UI/vial polvo y disolvente para solucion inyectable	Baxalta Innovations Gmbh	114970001	POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
Rixubis 2000UI/vial polvo y disolvente para solucion inyectable	Baxalta Innovations Gmbh	114970004	POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE	Uso Hospitalario	Commercialized
BENEFIX 500 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Pfizer Europe Ma Eeig	97047005	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
BENEFIX 2000 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Pfizer Europe Ma Eeig	97047007	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
BENEFIX 250 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Pfizer Europe Ma Eeig	97047004	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
Rixubis 500UI/vial polvo y disolvente para solucion inyectable	Baxalta Innovations Gmbh	114970002	POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
Rixubis 1000UI/vial polvo y disolvente para solucion inyectable	Baxalta Innovations Gmbh	114970003	POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE	Uso Hospitalario	Commercialized
BENEFIX 1000 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Pfizer Europe Ma Eeig	97047006	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
Rixubis 3000UI/vial polvo y disolvente para solucion inyectable	Baxalta Innovations Gmbh	114970005	POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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