Rebinyn® helps your patients achieve higher factor levels that are sustained longer.1,a

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  

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

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  

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

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

COMPARING REBINYN® WITH STANDARD HALF-LIFE FACTOR IX

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 standard half-life (SHL) recombinant FIX, as illustrated below:

Rebinyn® achieved and maintained higher factor activity1,a

Graph showing the Rebinyn® Mean FIX activity
Graph showing the Rebinyn® Mean FIX activity

Increase FIX activity

Rebinyn®: 1.31%d

SHL rFIX: 0.68%d

dUI/dL per IU/kg

Prolong time in the body

Rebinyn®: 93 hours

SHL rFIX: 19 hours

Keep FIX activity high

Rebinyn®: 72e

SHL rFIX: 7e

e(U x h/mL)

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.

EXTENDING HALF-LIFE

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

Rebinyn® stays in the body longer through PEGylation technology.3   

EFFECTIVE BLEED CONTROL

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

Clinical trials show the efficacy of Rebinyn® in controlling bleeds.1   

EXTENDING HALF-LIFE


Rebinyn® stays in the body longer through PEGylation technology.3   
 

EFFECTIVE BLEED CONTROL


Clinical trials show the efficacy of Rebinyn® in controlling bleeds.1   
 

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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.

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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. 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.