• Rebinyn^® is contraindicated in patients with a known hypersensitivity to Rebinyn^® or its components, including hamster proteins.

Hypersensitivity reactions, including anaphylaxis, may occur. Signs may include angioedema, chest tightness, difficulty breathing, wheezing, urticaria, and itching. Discontinue Rebinyn^® if allergic or anaphylactic type reactions occur and initiate appropriate treatment.

Rebinyn^®, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes and perioperative management of bleeding.

Limitations of Use: Rebinyn^® is not indicated for routine prophylaxis or for immune tolerance induction in patients with hemophilia B.

• Rebinyn^® is contraindicated in patients with a known hypersensitivity to Rebinyn^® or its components, including hamster proteins.

• Hypersensitivity reactions, including anaphylaxis, may occur. Signs may include angioedema, chest tightness, difficulty breathing, wheezing, urticaria, and itching. Discontinue Rebinyn^® if allergic or anaphylactic-type reactions occur and initiate appropriate treatment.

• Development of neutralizing antibodies (inhibitors) to Factor IX  may occur. Monitor patients for development of Factor IX inhibitors if bleeding is not controlled with the recommended dose of Rebinyn^® or if expected Factor IX activity plasma levels are not attained. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.
• The use of Factor IX-containing products has been associated with thrombotic complications. Monitor for thrombotic and consumptive coagulopathy when administering Rebinyn^® to patients with liver disease, post-operatively, to newborn infants, or to patients at risk of thrombosis or disseminated intravascular coagulation (DIC).
• Nephrotic syndrome has been reported following immune tolerance induction therapy with Factor IX products in hemophilia B patients with Factor IX inhibitors, often with a history of allergic reactions to Factor IX. The safety and efficacy of using Rebinyn^® for immune tolerance induction have not been established.

• The most common adverse reactions reported in clinical trials (≥1%) were itching and injection site reactions.
• Animals administered repeat doses of Rebinyn^® showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown.