STN: BL 103677
Proper Name:Coagulation Factor IX (Recombinant)
Manufacturer: Wyeth Pharmaceuticals LLC
BeneFIX is a recombinant human blood coagulation factor IX indicated for the treatment of:
Adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
- On-demand treatment and control of bleeding episodes.
- Perioperative management of bleeding.
Patients 16 years of age and older with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
- Routine prophylaxis to reduce the frequency of bleeding episodes.
Limitations of Use
BeneFIX is not indicated for induction of immune tolerance in patients with hemophilia B.
- April 20, 2021 Approval Letter - BeneFIX
- February 17, 2021 Partial Rescission of Approval - BeneFIX
- June 26, 2020 Approval Letter - BeneFIX
- Supporting Documents older than three years - BeneFIX