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REBINYN® may reduce the need for additional infusions6,a,b,c

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Rebinyn®

WFH target FIX

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SHL

WFH target FIX

rFIX
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Dashed lines=mean predicted FIX activity; shaded regions=95% confidence intervals for FIX activity.
a A single dose should be enough for minor and moderate bleeds. Your doctor may recommend additional doses of 40 IU/kg.6
b Based on a pharmacokinetic (PK) modeling to World Federation of Hemophilia (WFH) guidelines. Simulated results based on phase 1 PK study of Rebinyn® (n=15), recombinant FIX (rFIX) (n=7), and plasma-derived FIX (pdFIX) (n=8).6
c Compared with SHL products.6
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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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2. Choose SHL comparisonSHL comparison tabs
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