Higher factor activity for your hemophilia B patients
Versus BeneFIX® and Alprolix® in phase 1 trials, Rebinyn® helped patients achieve higher factor IX activity levels for longer.1,2
Abdiel lives with hemophilia B and uses Rebinyn®.
Higher factor activity for your hemophilia B patients
Versus BeneFIX® and Alprolix® in phase 1 trials, Rebinyn® helped patients achieve higher factor IX activity levels for longer.1,2
Abdiel lives with hemophilia B and uses Rebinyn®.
94% FIX activity
achieved after infusion in a phase 3 clinical trial, 17% sustained after 7 days with a single dose of Rebinyn 40 IU/kg in adults with ≤2% factor levels3,4,a
aBased upon a 2.34% increase in factor levels per IU/kg infused in adults.
98% bleed control
with 1-2 infusions in adults and adolescents3,4
0 inhibitors
and thrombotic events confirmed in clinical trials of PTPs3-5,b
PTPs=previously treated patients.
bIdentified in 115 previously treated patients who were treated with Rebinyn® in clinical studies. A previously treated patient was defined as a subject with a history of at least 150 exposure days to other FIX products (adolescent/adult subjects) or 50 exposure days to other FIX products (pediatric subjects) and no history of inhibitors. There were a total of 8801 exposure days, equivalent to 170 patient-years. A total of 40 patients (35%) were treated for more than 2 years.
Please see Prescribing Information.
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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.
Study designs
paradigm 1: phase 1 trial comparing PK of Rebinyn® with SHL FIX products (Negrier, et al.)
Based upon a phase 1 study of patients administered one of three doses of Rebinyn® (25, 50 or 100 IU/kg) compared with one dose of their prior SHL rFIX (N=7) or pdFIX (N=8) at the same dose using a one-stage assay and product-specific standard. Estimated mean PK parameters is adjusted to a dose of 50 IU/kg. Differences were similar in comparison of Rebinyn® to pdFIX (half-life 93 vs. 18 hours, 5.2x; AUC 70 vs. 9 U x h/mL, 8x) and in comparison of Rebinyn® to rFIX (half-life 93 vs. 19 hours; AUC 72 vs. 7 U x h/mL).1
paradigm 2: pivotal phase 3 clinical trial in adults and adolescents (Collins, et al.)
Based upon pharmacokinetic assessment of a single dose of Rebinyn® 40 IU/kg upon enrollment using one-stage assay and product-specific standard. For 6 adults (mean FIX activity after 7 days: 16.8%), recovery is based upon 2.34% increase in factor levels per IU/kg infused in adults. Assessments were also completed in 3 adolescents (mean FIX activity after 7 days: 14.6%).3
Bleed control results shown are from the on-demand arm of the adolescent/adult trial, in which 15 previously treated adolescent/adult subjects were treated for on-demand bleeds. In 14 subjects, there were a total of 143 bleeding episodes. In 1 subject, no bleeding episode data were recorded.3,4
paradigm 7: phase 1 trial comparing PK of Rebinyn® with Alprolix (Ettingshausen, et al.)
Based 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.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:
- 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.
- 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.
- Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2020.
- Collins PW, Young G, Knobe K, et al; paradigm 2 Investigators. Recombinant long-acting glycoPEGylated factor IX in hemophilia B: a multinational randomized phase 3 trial. Blood. 2014;124(26):3880-3886.
- Carcao M, et al. The Long-term safety and efficacy of nonacog beta pegol (n9-gp) administered for at least 5 years in previously treated children with hemophilia B. Thomb Haemost. 2020; 120(5):737-746).