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
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
PEG selectively attaches to the FIX activation peptide by site-directed glycoPEGylation3
Prolonged Circulation
GlycoPEGylation keeps Rebinyn® in the bloodstream longer where it needs to be to stop bleeding3
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
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:
- Swierczewska M, Lee KC, Lee S. What is the future of PEGylated therapies? Expert Opin Emerg Drugs. 2015;20(4):531-536.
- Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2020.
- 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.