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Rebinyn® helps your patients achieve higher factor levels that are sustained longer.1,a When compared with SHL and EHL products, Rebinyn® provides higher incremental recovery, longer half-life, and greater AUC.1-3,a

Jason, who lives with hemophilia B, plays with his dad
Jason, who lives with hemophilia B, plays with his dad

Rebinyn® helps your patients achieve higher factor levels that are sustained longer.1,a When compared with SHL and EHL products, Rebinyn® provides higher incremental recovery, longer half-life, and greater AUC.1-3,a

Jason, who lives with hemophilia B, plays with his dad
Jason, who lives with hemophilia B, plays with his dad

TAKE CONTROL WITH HIGH FACTOR ACTIVITY

In a phase 3 study, Rebinyn® elevated factor levels above baseline levels, with +94% achieved after an infusion in adults2,b and 17% sustained after 7 days in adults, adolescents, and children.2,c  

Rebinyn® elevates factor levels above your normal levels

With a single dose of Rebinyn® 40 IU/kg in adults with ≤2% factor levels2,c

aBased 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. 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).

bBased upon a 2.34% increase in factor levels per IU/kg infused in adults.

cBased on pharmacokinetic assessment of a single dose of Rebinyn® 40 IU/kg in 6 adults (mean FIX activity 16.8%), 3 adolescents (mean FIX activity 14.6%), 13 children ages 7 to 12 (mean FIX activity 10.9%), and 12 children ages 0-6 (mean FIX activity 8.4%) upon enrollment in the phase 3 trials using one-stage assay and product-specific standard. All values are geometric mean.

+94%

achieved after an infusion2,b

17%

sustained after 7 days2,c

With a single dose of Rebinyn® 40 IU/kg in adults with ≤2% factor levels2,c

aBased 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. 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).

bBased upon a 2.34% increase in factor levels per IU/kg infused in adults.

cBased on pharmacokinetic assessment of a single dose of Rebinyn® 40 IU/kg in 6 adults (mean FIX activity 16.8%), 3 adolescents (mean FIX activity 14.6%), 13 children ages 7 to 12 (mean FIX activity 10.9%), and 12 children ages 0-6 (mean FIX activity 8.4%) upon enrollment in the phase 3 trials using one-stage assay and product-specific standard. All values are geometric mean.

In the phase 3 study, Rebinyn® achieved an 83-hour mean half-life in adults.2,c

COMPARATIVE PK DATA: REBINYN® VS SHL rFIX

In a study of previously treated adult patients, Rebinyn® was shown to increase FIX activity by 2 times, prolong time in the body by 5 times, and keep activity level higher by 10 times when compared with BeneFIX®, as illustrated below:

Comparison of Rebinyn® and BeneFIX:

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.

IN A PHASE 1 STUDY, COMPARED WITH BENEFIX, REBINYN® SHOWED1,a

2x

HIGHER RECOVERY1

5x

LONGER HALF-LIFE1

10x

GREATER AUC1

dPer IU/kg.

  • 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.

COMPARATIVE PK DATA: REBINYN® VS EHL FIX

In the paradigm™7 study, compared to Alprolix®, Rebinyn® was shown to increase FIX activity by 2 times, achieve 6 times higher factor activity at 7 days, and keep activity level higher by 4 times, as illustrated below:
 

Comparison of Rebinyn® and Alprolix:

Rebinyn® achieved and maintained higher factor activity3,e

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 one-stage 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.3  

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

IN A PHASE 1 STUDY, COMPARED WITH ALPROLIX, REBINYN® SHOWED3,e

2x

HIGHER RECOVERY3

6x

FACTOR ACTIVITY AT 7 DAYS3

4x

GREATER AUC3


f
Per IU/kg.

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

COMPARE FIX TREATMENTS

See PK modeling data comparing Rebinyn® to SHL products for bleed control and target FIX levels in surgery.

COMPARE FIX TREATMENTS

See PK modeling data comparing Rebinyn® to SHL products for bleed control and target FIX levels in surgery.

EXTENDING HALF-LIFE

Rebinyn® extends half-life & stays in the body longer through PEGylation technology

Rebinyn® stays in the body longer through PEGylation technology.4  

SIMPLIFIED DOSING

Jason, who lives with hemophilia B, plays with his dad in a garden

Fixed dosing for all patients means no calculating desired factor IX activity levels.2  

EXTENDING HALF-LIFE

Rebinyn® stays in the body longer through PEGylation technology.4  
 

SIMPLIFIED DOSING

Fixed dosing for all patients means no calculating desired factor IX activity levels.2
 

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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; May 2017.
  3. Escuriola Ettingshausen C, Hegemann I, Simpson ML, 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;00:1–9.
  4. Østergaard H, Bjelke JR, Hansen L, et al. Prolonged half-life and preserved enzymatic properties of factor IX selectively PEGylated on native N-glycans in the activation peptide. Blood. 2011;118(8):2333-2341.