Predict FIX PK profiles of SHL and EHL products. View online
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Important Safety Information  |  Prescribing Information
Rebinyn® Coagulation IX factor (Recombinant), GlycoPEGylated.
Indicated for use in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management of bleeding.
Consider Rebinyn® as the FIX product of choice
Our interactive tool enables you to compare the PK profile of Rebinyn® with SHL and EHL products.
Try the PK Tool
Open laptop showing an illustration of the Rebinyn® PK tool.
Open laptop showing an illustration of the Rebinyn® PK tool.
How the PK tool works
Choose the type of factor you want to evaluate—either SHL or EHL—then identify the type of bleed and the PK tool will:
 
Illustrated graph showing downward trend.
Display each PK profile vs. Rebinyn®
Illustrated number symbol.
Estimate the number of infusions needed
Illustrated question mark and vial.
Show the total dosage of factor required
Illustrated graph showing downward trend. Display each PK profile vs. Rebinyn®
Illustrated number symbol. Estimate the number of infusions needed
Illustrated question mark and vial. Show the total dosage of factor required
 Try the PK Tool 
EHL=extended half-life; SHL=standard half-life; PK=pharmacokinetics
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.
Please click here or scroll below for additional Important Safety Information.
 
Improved PK profiles for your hemophilia B patients
Based on PK modeling, Rebinyn® required fewer infusions per bleeding episode when compared with SHL and EHL FIX products.1,2,a-c
 See Infusions 
Illustrated depiction of PK comparison tool.
aA single Rebinyn® dose should be sufficient for minor and moderate bleeds. Additional doses of 40 IU/kg can be given.3
bBased on PK modeling to World Federation of Hemophilia (WFH) guidelines. Simulated results based on a phase 1 PK study of Rebinyn® (n=15), recombinant FIX (rFIX) (n=7), and plasma-derived FIX (pdFIX) (n=8).1
cBased on PK modeling to WFH guidelines. Simulated results based on phase 1 PK study of Rebinyn® and rFIXFc (n=15).2
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 (cont’d)
Warnings and Precautions
•   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 Prescribing Information.
Reference
1. Collins PW, Møss J, Knobe K, et al. Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX. J Thromb Haemost. 2012;10(11):2305-2312.
2. Simpson M, Kulkarni R, Ettingshausen C, et al. Population pharmacokinetic modeling of on-demand and surgical use of nonacog beta pegol (N9-GP) and rFIXFc based upon the paradigm 7 comparative pharmacokinetic study. J Blood Med. 2019;10:391–398.
3. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2020.
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