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These highlights do not include all the information needed to use BeneFIX safely and effectively. See full prescribing information for BeneFIX. BeneFIX® [coagulation factor IX (recombinant)] lyophilized powder for solution, for intravenous use Initial U.S. Approval: 1997
Medication labelWhy this: Advisory · dailymed-other
BeneFIX®, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: oOn-demand treatment and control of bleeding episodes oPerioperative management of bleeding oRoutine prophylaxis to reduce the frequency of bleeding episodes Limitation of Use BeneFIX is not indicated for induction of immune tolerance in patients with hemophilia B [see Warnings and Precautions (5.3)].
- generic_name
- coagulation factor ix (recombinant)
- brand_name
- diluent, alcohol
- product_names
- coagulation factor ix (recombinant), diluent, alcohol
- ndc
- 58394-633, 58394-634, 58394-635, 58394-636, 58394-637, 58394-635-03, 58394-135, 58394-135-03, 58394-041, 58394-041-11, 0069-1111, 0069-1111-01, 58394-636-03, 58394-136, 58394-136-03, 58394-634-03, 58394-134, 58394-134-03, 58394-633-03, 58394-133, 58394-133-03, 58394-637-03, 58394-137, 58394-137-03
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en