(nonacog alfa)
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 INDICATIONS AND USAGEBeneFIX is a recombinant human blood coagulation factor IX indicated for adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
Limitations of Use BeneFIX is not indicated for induction of immune tolerance in patients with hemophilia B. (1) DOSAGE AND ADMINISTRATIONFor intravenous use after reconstitution only.
DOSAGE FORMS AND STRENGTHSBeneFIX is available as lyophilized powder in single-use vials containing nominally 250, 500, 1000, 2000, or 3000 IU. (3) CONTRAINDICATIONSDo not use in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein. (4) WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSThe most common adverse reactions (incidence >5%) from clinical trials were fever, cough, nausea, injection site reaction, injection site pain, headache, dizziness and rash. (6) To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals LLC at 1-800-934-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 11/2022 |
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