HIGHLIGHTS OF PRESCRIBING INFORMATION
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
INDICATIONS AND USAGE
BeneFIX 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 ADMINISTRATION
For intravenous use after reconstitution only.
DOSAGE FORMS AND STRENGTHS
BeneFIX is available as lyophilized powder in single-use vials containing nominally 250, 500, 1000, 2000, or 3000 IU. (3)
Do 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
The 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 POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
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