• BeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein (CHO).
• Hypersensitivity reactions, including anaphylaxis, have been reported with BeneFIX. Closely monitor patients for signs and symptoms of acute anaphylaxis, particularly during the early phases of initial exposure to the product. Immediately discontinue the administration of the product and initiate appropriate treatment if symptoms occur.
• Patients may develop hypersensitivity to hamster protein as BeneFIX contains trace amounts.
• BeneFIX has been associated with the development of thromboembolic complications, including in patients receiving continuous infusion through a central venous catheter. The safety and efficacy of BeneFIX administration by continuous infusion have not been established.
• Neutralizing antibodies (inhibitors) have been reported following the administration of BeneFIX. If expected plasma factor IX activity levels are not attained, or if the patient presents with an allergic reaction, or if bleeding is not controlled following an expected dose of BeneFIX, perform an assay that measures factor IX inhibitor concentration.
• The most common adverse reactions (>5%) from clinical trials were fever, cough, nausea, injection site reaction, injection site pain, headache, dizziness, and rash.

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 the on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine 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.

Please see full Prescribing Information for BeneFIX.