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Novo Nordisk supports patients at every phase of the journey. Explore our services, tools, and resources. Or, connect with a Novo Nordisk representative to learn more.

Jason, who lives with hemophilia B, plays with his dad
Jason, who lives with hemophilia B, plays with his dad

> > At a Glance

Novo Nordisk supports patients at every phase of the journey. Explore our services, tools, and resources. Or, connect with a Novo Nordisk representative to learn more.

Jason, who lives with hemophilia B, plays with his dad
Jason, who lives with hemophilia B, plays with his dad

QUICKCHECK™

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QuickCheck™ offers benefits verification. A NovoSecure™ Specialist assists to verify coverage, and usually within 4 hours, your office will receive the Summary of Benefits.

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PATIENT EDUCATION

Rebinyn® patient education materials

Our informative educational resources can help your patients learn more about living with hemophilia. Download, share, or order for your office.

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PRODUCT SUPPORT

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Novo Nordisk offers services through NovoSecure™, a support program designed to assist your patients throughout the reimbursement process.

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QUICKCHECK™

QuickCheck™ benefits verification logo

   Get the Details   

PATIENT EDUCATION

Rebinyn® patient education materials

   View Educational Materials   

PRODUCT SUPPORT

NovoSecure™ logo

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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.

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