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

Comparing FIX PK activity: Rebinyn® vs. SHL and EHL


Jason, 8, lives with hemophilia B.

Rebinyn® provides higher incremental recovery, a longer half-life, and greater AUC than BeneFIX® or Alprolix®.1-3  

Comparing FIX PK activity: Rebinyn® vs. SHL and EHL


Leopoldo playing soccer

Rebinyn® provides higher incremental recovery, a longer half-life, and greater AUC than BeneFIX® or Alprolix®.1-3  

PK: Compare Rebinyn® with BeneFIX

In a phase 1 study, compared to BeneFIX, Rebinyn® was shown to1: 

See study design

Increase FIX activity

2x recovery rate
Rebinyn®: 1.31% Per IU/kg; BeneFIX: 0.68% Per IU/kg

Prolong time in the body

5x half-life
Rebinyn®: 93 hours; BeneFIX: 19 hours

Keep FIX activity higher

10x area under the curve
Rebinyn®: 72 (IU x h/mL) ; BeneFIX: 7(IU x h/mL)

aPer IU/kg.

b(IU x h/mL).  

Rebinyn® achieved and maintained higher factor activity1

Factor IX over time chart

The estimated time to 1% with Rebinyn® was 22.5 days.1

  • Rebinyn® is not approved for routine prophylaxis.2
  • Animals given repeat doses of Rebinyn® showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown.2 

PK: Compare Rebinyn® with Alprolix

In the paradigm 7 study, compared to Alprolix, Rebinyn® was shown to3: 

See study design

Increase FIX activity

2x Recovery Rate
Rebinyn®: 1.71% Per IU/kg; Alprolix: 0.8% Per IU/kg

P<0.0001

Keep FIX activity higher

4x Area under the curve
Rebinyn®: 96.6 IU x h/mL; Alprolix: 22.0 IU x h/mL

P<0.0001

Maintain FIX levels at 7 days

6x Higher factor levels
Rebinyn®: 19%; Alprolix: 3%

P<0.0001

cPer IU/kg.

dIU x h/mL.

Rebinyn® achieved and maintained higher factor activity3

The half-life of Rebinyn® was 103 hours vs. 85 hours for Alprolix.3

  • The clinical relevance of these PK differences is unknown
  • Rebinyn® is not approved for routine prophylaxis

Would a switch to Rebinyn® help a patient like Alex?

Alex is 28 and lives with moderate hemophilia B. He’s been thinking about aging, bleed protection, and long-term joint damage. Find out more about what patients like Alex look for when considering a therapy switch.

See patient case examples
Alex patient profiles

For illustrative purposes.

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 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.3  

Tools to help you compare PK of FIX products

Modeling data icon

Explore PK modeling data comparing Rebinyn® with SHL and EHL FIX products.

Use the PK Modeling Tool

Established safety profile

Clinical trials showed 0 inhibitors and thrombotic events in previously treated patients.2  

View the data

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. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2020.
  3. 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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