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Prescribing Information

Selected Important Safety Information

Contraindications

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

Warnings and Precautions

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.

Indications and Usage

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.

Important Safety Information

Contraindications

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

Warnings and Precautions

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.

Adverse Reactions

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.

RebinynPro

Coagulation Factor IX (Recombinant), GlycoPEGylated