This Factor IX therapy can help your patients achieve higher PK levels for longer. 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.
Your patients could stay in the non-hemophilia range for longer
     
The high incremental recovery of Rebinyn® boosts Factor IX (FIX) levels into a range that, when combined with the extended half-life, allows for prolonged periods in the non-hemophilia range.1,2,a
 See the Data 
Factor IX (FIX) activity level graph.
Factor IX (FIX) activity level graph.
A single dose of Rebinyn® (40 IU/kg) achieved a 94% increase in FIX activity level and a 2.34% incremental recovery 30 minutes after infusion.1,a,c
 
 
Rebinyn® achieved an 83-hour half-life in adults.1,a
aBased on pharmacokinetic (PK) assessment of a single dose of Rebinyn® 40 IU/kg in 6 adults (mean FIX activity after 7 days 16.8%), 3 adolescents (mean FIX activity 14.6%), 13 children aged 7-12 (mean FIX activity 10.9%), and 12 children aged 0-6 (mean FIX activity 8.4%) upon enrollment in the phase 3 trials using 1-stage assay and product specific standard. All values are geometric mean.
bBased upon a 2.34% increase in factor levels per IU/kg infused in adults.1
cFactor levels were elevated above baseline in adults with factor levels ≤2%.
Scroll to see comparative data.
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.
 
Higher factor levels for longer, compared to BeneFIX® and Alprolix®
Rebinyn® has an improved PK profile compared to BeneFIX® and Alprolix®. Rebinyn® has higher incremental recovery, longer half-life, and greater area under the curve than BeneFIX® and Alprolix®.1,3,4,a,c
Rebinyn® achieved and maintained a higher factor activity than BeneFIX® and Alprolix®1,4,d,e,f,g
Comparison to BeneFIX®
Rebinyn factor activity comparison to BeneFIX graph.
Rebinyn factor activity comparison to BeneFIX graph.
Comparison to Alprolix®
Rebinyn factor activity comparison to Alprolix graph.
Rebinyn factor activity comparison to Alprolix graph.
• Rebinyn® is not approved for routine prophylaxis
• Animals given repeat doses of Rebinyn® showed accumulation of PEGylation in the choroid plexus. The potential clinical implications of these animal findings are unknown
 Compare the Data 
dBased upon a phase 1 study of patients administered one of three doses of Rebinyn® (25, 50, or 100 IU/kg) compared with one 50 IU/kg dose of their prior SHL rFIX (n=7) or pdFIX (n=8) using a one-stage assay and product-specific standard. For Rebinyn®, estimated mean activity is adjusted to a dose of 50 IU/kg to allow for comparison of dose-dependent parameters. Differences were similar in comparison of Rebinyn® to pdFIX recovery 1.3 vs 1.1 IU/dL per IU/kg, 1.2x; half-life 93 vs 18 hours, 5.2x; AUC 70 vs 9 U x h/mL, 8x).3
eBased upon a phase 1 study of 15 patients administered a single dose of Rebinyn® 50 IU/kg compared with a single dose of Alprolix 50 IU/kg using both 1-stage (shown above) and chromogenic assays. The standard Alprolix dose of 50 IU/kg was administered for both products to allow for comparison of dose-dependent parameters; dose normalized to 50 IU/kg to reflect minor differences in dose administered. Geometric mean half-life was also prolonged (Rebinyn®: 103.2 hours, Alprolix: 84.9 hours). All comparisons were significant (P<0.0001) for all assays.4
fIU x h/mL.
gPer IU/kg.
 
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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 (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.
References
1. Rebinyn® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; June 2020.
2. Collins PW, Young G, Knobe K, et al. Recombinant long-acting glycoPEGylated factor IX in hemophilia B: a multinational randomized phase 3 trial. Blood. 2014;124(26):3880-3886.
3. Negrier C, Knobe K, Tiede A, Giangrande P, Møss J. Enhanced pharmacokinetic properties of a glycoPEGylated recombinant factor IX: a first human dose trial in patients with hemophilia B. Blood. 2011;118(10):2695-2701.
4. Ettingshausen C, Hegemann I, Simpson M, et al. Favorable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant factor IX-Fc fusion protein: a randomized trial. Res Pract Thromb Haemost. 2019;3(2):268-276.
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