The safety of Rebinyn® has been studied in clinical trials, with 0 inhibitors and thrombotic events confirmed in 115 previously treated males over 8801 exposure days.1,2,a

  • Adverse reactions include hypersensitivity (1%), itching (3%), and injection-site reactions (4%)1,a
  • Formation of inhibitors and thrombotic complications have been associated with FIX treatment. Monitor patients for the development of inhibitors and signs of thrombosis1

Results from studies with previously treated patients:

0 inhibitors

and thrombotic events1,2,a


a
Identified 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.

The safety of Rebinyn® has been studied in clinical trials, with 0 inhibitors and thrombotic events confirmed in 115 previously treated males over 8801 exposure days.1,2,a

Results from studies with previously treated patients:

0 inhibitors

and thrombotic events1,2,a

  • Adverse reactions include hypersensitivity (1%), itching (3%), and injection-site reactions (4%)1,a
  • Formation of inhibitors and thrombotic complications have been associated with FIX treatment. Monitor patients for the development of inhibitors and signs of thrombosis1

aIdentified 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.

MANUFACTURED TO HELP ENSURE SAFETY AND PURITY

Rebinyn® is a recombinant factor IX treatment made without human blood, plasma, or proteins. Recombinant factor IX products are recommended as a first-line therapy for patients with hemophilia B.3

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The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) recommends recombinant factor IX products as a first-line therapy for patients with hemophilia B.3

Animals administered repeat doses of Rebinyn® showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown.

REBINYN® TRIAL PROGRAM

Considering Rebinyn® for your patients with hemophilia B? Get a 1-month trial prescription for qualifying patients.b

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

bPatients 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.

Considering Rebinyn® for your patients with hemophilia B? Get a 1-month trial prescription for qualifying patients.b

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

bPatients 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.

CONNECT WITH US

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Novo Nordisk representatives are here to help. Enter your zip code to find a Novo Nordisk representative.

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

CONNECT WITH US


Novo Nordisk representatives are here to help. Enter your zip code to find a Novo Nordisk representative.
 

EXTENDING HALF-LIFE


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

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. 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.
  3. National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders, #250. New York, NY: National Hemophilia Foundation; 2017.
  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.