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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

> > Pharmacokinetics

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

PEDIATRIC PATIENTS SHOWED ELEVATED FACTOR ACTIVITY IN CLINICAL TRIALS

PEDIATRIC PATIENTS SHOWED ELEVATED

FACTOR ACTIVITY IN CLINICAL TRIALS

In paradigm™ 2 and paradigm™ 5, a single dose of Rebinyn® 40 IU/kg elevated factor levels above baseline in children and adolescents aged 17 and younger.2,d

dBased on pharmacokinetic assessment of a single dose of Rebinyn® 40 IU/kg in 3 adolescents (mean FIX activity 14.6%), 13 children aged 7-12 (mean FIX activity 10.9%), and 12 children aged 0-6 (mean FIX activity 8.4%) upon enrollment in the phase 3 trials using 1-stage assay and product-specific standard. All values are geometric mean.2
eBased upon a 1.51% increase in factor levels per IU/kg infused in children aged ≤6.2
fBased upon a 1.59% increase in factor levels per IU/kg infused in children aged 7-12.2
gBased upon a 1.96% increase in factor levels per IU/kg infused in adolescents aged 13-17.2

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

hPer 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,i

iBased 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

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,i

2x

HIGHER RECOVERY3

6x

FACTOR ACTIVITY AT 7 DAYS3

4x

GREATER AUC3


jPer 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.

Go to FIX comparison

COMPARE FIX TREATMENTS

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

Go to FIX comparison

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  

   See How It Works    

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  

   See Our Dosing   

EXTENDING HALF-LIFE

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

   See How It Works   

SIMPLIFIED DOSING

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

   See Our Dosing   

REGISTER TO GET THE LATEST UPDATES ON REBINYN®

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REGISTER TO GET THE LATEST UPDATES ON REBINYN®

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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; 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.
  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.