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Rebinyn® coagulation factor IX (recombinant), glycoPEGylated logo
Important Safety Information | Patient Site
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Rebinyn® coagulation factor IX (recombinant), glycoPEGylated logo

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.

Prescribing Information
Important Safety Information | Patient Site

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  

See study design
Compare FIX PK data

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

See study design
Compare FIX PK data

Abdiel lives with hemophilia B and uses Rebinyn®.

Jason

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  

See study design
See the data

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 

See study design
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0 inhibitors

and thrombotic events confirmed in clinical trials of PTPs3-5,b  

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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.


Prescribing Information | Important Safety Information
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Emili, a caregiver for her young son Xander, shares why she chose Rebinyn® to treat his hemophilia B.
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Prescribing Information | Important Safety Information

Please see Prescribing Information.

Have questions about Rebinyn®?

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:

  1. 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.
  2. 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.
  3. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2020.
  4. 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.
  5. 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).
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