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COMPARING FIX PK ACTIVITY: REBINYN® vs SHL and EHL

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

Markus lives with hemophilia B and still goes camping


a
Based upon a phase 1 study of patients administered 1 of 3 doses of Rebinyn® (25, 50 or 100 IU/kg) compared with one 50 IU/kg dose of their prior SHL recombinant FIX (rFIX) (n=7) or plasma-derived FIX (pdFIX) (n=8) using a 1-stage assay and product-specific standard. For Rebinyn®, estimated mean activity is adjusted to a dose of 50 IU/kg. 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; area under the curve 70 vs 9 U x h/mL, 8x). 

bBased 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 both assays.3

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

Markus lives with hemophilia B and still goes camping


a
Based upon a phase 1 study of patients administered 1 of 3 doses of Rebinyn® (25, 50 or 100 IU/kg) compared with one 50 IU/kg dose of their prior SHL recombinant FIX (rFIX) (n=7) or plasma-derived FIX (pdFIX) (n=8) using a 1-stage assay and product-specific standard. For Rebinyn®, estimated mean activity is adjusted to a dose of 50 IU/kg. 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; area under the curve 70 vs 9 U x h/mL, 8x). 

bBased 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 both assays.3

PK: COMPARE REBINYN® WITH BENEFIX


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

 

cPer IU/kg.
d(IU x h/ML).

Rebinyn® achieved and maintained higher factor activity1,a

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


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

PK: COMPARE REBINYN® WITH ALPROLIX


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

 

ePer IU/kg.
fIU x h/mL.

Rebinyn® achieved and maintained higher factor activity3,b

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

     

For illustrative purposes.

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.
 

TOOLS TO HELP YOU COMPARE PK OF FIX PRODUCTS

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

ESTABLISHED SAFETY PROFILE

Yellow test tubes

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

TOOLS TO HELP YOU COMPARE PK OF FIX PRODUCTS

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

ESTABLISHED SAFETY PROFILE

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

GET THE LATEST UPDATES ON REBINYN®

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GET THE LATEST UPDATES ON REBINYN®

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.

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 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.