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Medical Information | Non-US Health Care Professionals
Important Safety Information | Patient Site
Prescribing Information
Rebinyn® coagulation factor IX (recombinant), glycoPEGylated logo

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.

Prescribing Information
Important Safety Information | Patient Site

Achieving extended half-life

Rebinyn® is a therapy that extends half-life through the use of PEGylation (PEG) technology.1,a  

aPEG=polyethylene glycol.

Achieving extended half-life

Rebinyn® is a therapy that extends half-life through the use of PEGylation (PEG) technology.1,a  

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How it works

The Factor IX in Rebinyn® is conjugated to a 40-kDa polyethylene glycol molecule, which slows down its removal from the blood circulation.2  

Selective Attachment

Selective Attachment

PEG selectively attaches to the FIX activation peptide by site-directed glycoPEGylation3  

Prolonged Circulation

Prolonged Circulation

GlycoPEGylation keeps Rebinyn® in the bloodstream longer where it needs to be to stop bleeding3  

Activated FIX Release

Activated FIX Release

Rebinyn® releases rFIX similar to native human FIX once activated3  

aPEG=polyethylene glycol.

Adverse 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.2  

PEGylation is an established technology, used to extend half-life.1  

Rebinyn® trial prescription program

Rebinyn Box

Considering Rebinyn® for your patients with hemophilia B?

To learn more about our trial prescription program, please call 1-844-668-6732 to speak with a NovoSecure™ Specialist.

Established safety profile

Clinical trials showed 0 inhibitors and thrombotic events in previously treated patients.2  

Selected Important Safety Information for Rebinyn®

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.

Please click here for Rebinyn® Prescribing Information.

References:

  1. Swierczewska M, Lee KC, Lee S. What is the future of PEGylated therapies? Expert Opin Emerg Drugs. 2015;20(4):531-536.
  2. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2020.
  3. Østergaard H, Bjelke JR, Hansen L, et al. Prolonged half-life and preserved enzymatic properties of factor IX selectively PEGylated on native N-glycans in the activation peptide. Blood. 2011;118(8):2333-2341.