Benefix Side Effects, and Drug Interactions - Coagulation Factor IX (Recombinant)

Benefix Side Effects, and Drug Interactions - Coagulation Factor IX (Recombinant)

SIDE EFFECTS

As with the intravenous administration of any protein product, the following reactions may be observed after administration: headache, fever, chills, flushing, nausea, vomiting, lethargy, or manifestations of allergic reactions. Should evidence of an acute hypersensitivity reaction be observed, the infusion should be stopped promptly and appropriate counter measures and supportive therapy should be administered.

During clinical studies with BeneFIX®, Coagulation Factor IX (Recombinant), conducted in previously-treated patients (PTPs), 60 mild adverse reactions definitely, probably, or possibly related to therapy were reported for 2,548 infusions. These were nausea (16), discomfort at the IV site (13), altered taste (10), burning sensation in the jaw and skull (6), allergic rhinitis (3), light-headedness (2), headache (2), dizziness (1), chest tightness (1), fever (1), phlebitis/cellulitis at IV site (1), drowsiness (1), dry cough/sneeze (1), rash (1), and a single hive (1). Twelve days after a dose of BeneFIX® for a bleeding episode, one hepatitis C antibody positive patient developed a renal infarct. The relationship of the infarct to prior administration of BeneFIX® is uncertain but was judged to be unlikely by the investigator. The patient continued to be treated with BeneFIX®.

The following post-marketing adverse reactions have been reported for BeneFIX®, as well as for plasma-derived factor IX products: inadequate factor IX recovery, inadequate therapeutic response, inhibitor development (see CLINICAL PHARMACOLOGY ), anaphylaxis (see WARNINGS), laryngeal edema, angioedema, cyanosis, dyspnea, hypotension, thrombosis.

If any adverse reaction takes place that is thought to be related to the administration of BeneFIX® the rate of infusion should be decreased or the infusion stopped.

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