TAKE CONTROL TO A HIGH LEVEL IN HEMOPHILIA B

With Rebinyn®, achieve high factor activity levels for longer.1

All images of hemophilia B patients shown are for illustrative purposes only.

TAKE CONTROL TO A HIGH LEVEL IN HEMOPHILIA B

With Rebinyn®, achieve high factor activity levels for longer.1

Clayton lives with hemophilia B and hikes
Clayton lives with hemophilia B and hikes

All images of hemophilia B patients shown are for illustrative purposes only.

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 the treatment of patients with hemophilia B.1

REBINYN® AT A GLANCE:

Achieved control in 95% of bleeds; 98% of bleeds treated with 1-2 infusions.1,a,b
Learn about efficacy

No need to calculate desired FIX activity levels when determining the appropriate dose.1 
Find out about dosing

Elevates factor activity above baseline levels. +94% achieved after infusion, 17% sustained after 7 days.1,c,d
See the data

With 0 inhibitors and thrombotic events confirmed in clinical trials of previously treated patients.1,2,e
Review study results

aResults shown are based on a bleed assessment by either the patient (for home treatment) or the study investigator (for treatment under medical supervision). Bleeds were assessed using a 4-point scale of excellent, good, moderate, or poor.

bResults shown are from the on-demand arm of the adolescent/ adult trial, in which 15 previously treated adolescent/adult subjects were treated for on-demand bleeds. In 14 subjects, there were a total of 143 bleeding episodes. In 1 subject, no bleeding episode data were recorded.

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

dBased 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.

eIdentified in 115 previously treated patients who were treated with Rebinyn® in clinical studies. A previously treated patient was defined as a subject with a history of at least 150 exposure days to other FIX products (adolescent/adult subjects) or 50 exposure days to other FIX products (pediatric subjects) and no history of inhibitors. There were a total of 8801 exposure days, equivalent to 170 patient-years. A total of 40 patients (35%) were treated for more than 2 years. 

POPULAR RESOURCES FOR YOUR PATIENTS

TRIAL PRESCRIPTION PROGRAM

Is Rebinyn® right for your patients with hemophilia B? We are now offering a 1-month trial prescription for qualifying patients.f

To learn more about our trial prescription program, please call 1-844-NOVO-SEC (1-844-668-6732) to speak with a NovoSecure™ Specialist.

fPatients who have been prescribed a Novo Nordisk hemophilia and rare bleeding disorder product for an FDA-approved indication, and who have commercial insurance, may be eligible to receive a limited supply of free product. Patients who participate in any government, state, or federally funded medical or prescription benefit program, including Medicare, Medicaid, Medigap, VA, DOD, and TRICARE, including patients who participate in a managed Medicaid program or have Medicaid as secondary insurance, are not eligible to receive product support. Product is provided at no cost to the patient or the HCP, is not contingent on any product purchase, and the patient and HCP must not: (1) bill any third party for the free product, or (2) resell the free product. 

QUESTIONS ABOUT REBINYN®?

WE’RE HERE TO HELP

Icon of four people standing

Enter your zip code to find a Novo Nordisk representative.

SUPPORT FOR YOUR PATIENTS

Rebinyn® patient support

Novo Nordisk provides resources to help your patients.

QUESTIONS ABOUT REBINYN®?

WE’RE HERE TO HELP

Enter your zip code to find a Novo Nordisk representative.

SUPPORT FOR YOUR PATIENTS

Novo Nordisk provides resources to help your patients.

REGISTER TO GET THE LATEST UPDATES ON REBINYN®

Website link

REGISTER TO 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; May 2017.
  2. Collins PW, Young G, Knobe K, et al; paradigm 2 Investigators. Recombinant long-acting glycoPEGylated factor IX in hemophilia B: a multinational randomized phase 3 trial. Blood. 2014;124(26):3880-3886.