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Rebinyn® helps adults, adolescents, and children achieve high factor levels.1,a,b

Emili, whose son Xander, lives with hemophilia B and uses Rebinyn®.

Rebinyn® helps adults, adolescents, and children achieve high factor levels.1,a,b

Emili, whose son Xander, lives with hemophilia B and uses Rebinyn®.

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 adults1,a and 17% sustained after 7 days in adults, adolescents, and children.1,b

Rebinyn® elevates factor levels above your normal levels

With a single dose of Rebinyn® 40 IU/kg in adults with ≤2% factor levels1,b

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 infusion1,a

17%

sustained after 7 days1,b

With a single dose of Rebinyn® 40 IU/kg in adults with ≤2% factor levels1,b

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

bBased 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.1,b

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.1,c

cBased 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.1
dBased upon a 1.51% increase in factor levels per IU/kg infused in children aged ≤6.1
eBased upon a 1.59% increase in factor levels per IU/kg infused in children aged 7-12.1
fBased upon a 1.96% increase in factor levels per IU/kg infused in adolescents aged 13-17.1

For illustrative use.

Karl is 17 and lives with mild hemophilia B. Learn more about what patients like him are looking for in a factor IX treatment.

TOOLS TO HELP YOU COMPARE PK OF FIX PRODUCTS

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

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

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  

TOOLS TO HELP YOU COMPARE PK OF FIX PRODUCTS

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

SIMPLIFIED DOSING

Fixed dosing for all patients means no calculating desired factor IX activity levels.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. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2020.