Indication for BeneFix

BeneFix^® Coagulation Factor IX (Recombinant) is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including peri-operative management.

BeneFix is NOT indicated for the treatment of other factor deficiencies (eg, factors II, VII, VIII and X), hemophilia A patients with inhibitors to factor VIII, reversal of coumarin-induced anticoagulation, or bleeding due to low levels of liver-dependent coagulation factors.

Important Safety Information for BeneFix

• BeneFix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
• Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with the product should be discontinued, and emergency treatment should be sought.
• BeneFix has been associated with the development of throboembolic complications, including patients receiving continuous infusion through a central venous catheter. The safety and efficacy of BeneFix administration by continuous infusion have not been established.
• Development of activity-neutralizing antibodies has been detected in patients receiving factor IX products. If expected plasma factor IX activity levels are not attained, or if patient presents with allergic reaction, or if bleeding is not controlled with an expected dose, an assay that measures factor IX inhibitor concentration should be performed.
• Patients may develop hypersensitivity to hamster (CHO) protein as BeneFix contains trace amounts.
• The most common adverse reactions (>5%) from clinical trials were nausea, injection site reaction, injection site pain, headache, dizziness and rash.

Please see full Prescribing Information for BeneFix.