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Rebinyn® coagulation factor IX (recombinant), glycoPEGylated logo
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Rebinyn® coagulation factor IX (recombinant), glycoPEGylated logo

For use in adults and children with hemophilia B for on demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. See Limitations of Use below.

Prescribing Information
Important Safety Information | Patient Site

Financial programs and support for patients

Novo Nordisk provides assistance through NovoCare®, a network to help your patients access co-pay savings, product support, and more.


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NovoCare® is designed for your patients

Patients can access:

  • Product support programs that help with treatment costs
  • Representatives who speak Spanish to better serve them

You can help your patients by calling 1-844-668-6732 or have them contact NovoCare® at NovoCare.com


NovoCare® can help with:

QuickCheck™ benefits verification

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Verify your patients’ benefits and receive confirmation of coverage. If no coverage is available, names of alternative therapies may be supplied.

Patient Assistance Program (PAP)

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See if your patients are eligible to receive their treatment free of charge. No registration or monthly fees required.

Eligibility and restrictions apply

Patient Trial
Program

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Find out if your patients qualify to receive a limited supply of Novo Nordisk’s product for free.


Eligibility and restrictions apply

Patient
enrollment form

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Download and complete the patient enrollment form to attest your patient’s need for treatment.

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Additional resources for patients

Co-pay Assistance Program
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Co-pay Assistance Program
Direct your commercially-insured patients to our program to find out if they're eligible for a lower copay with a savings offer.
Eligibility and restrictions apply
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Interim Product Program

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This limited program provides hemophilia therapy to qualifying patients during a coverage gap. Contact NovoCare® by calling 1-844-668-6732.

Free Trial Prescription

500 IU Range Package of Rebinyn® Coagulation Factor IX (Recombinant), GlycoPEGylated

Help your patients make the switch to Rebinyn®. Learn more about Novo Nordisk’s trial prescriptionc and support programs—call 1-844-668-6732 to speak with NovoCare®.

Looking for other Rebinyn® resources?

Selected Important Safety Information for Rebinyn®

Contraindications

  • Rebinyn® is contraindicated in patients with a known hypersensitivity to Rebinyn® or its components, including hamster proteins.

Warnings and Precautions

  • Hypersensitivity Reactions: Allergic-type hypersensitivity reactions, including anaphylaxis, have occurred with Rebinyn®. 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 (congenital Factor IX deficiency) for on demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. 

Limitations of Use: Rebinyn® is not indicated 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: Allergic-type hypersensitivity reactions, including anaphylaxis, have occurred with Rebinyn®. 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.
  • Inhibitors: The formation of inhibitors (neutralizing antibodies) to Factor IX has occurred following Rebinyn®. If expected plasma factor IX activity levels are not attained, or if bleeding is not controlled as expected with the administered dose, perform an assay that measures Factor IX inhibitor concentration. Monitor all patients using clinical observations and laboratory tests for the development of inhibitors. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.
  • Thrombotic Events: The use of Factor IX-containing products has been associated with thromboembolic 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: 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 previously treated patients in clinical trials (≥1%) were itching and injection site reactions. The most common adverse reactions (≥1%) in previously untreated patients reported in clinical trials were rash, FIX inhibitors, hypersensitivity, itching, injection site reaction, and anaphylactic reaction.
  • Animals administered Rebinyn® showed accumulation of PEG in the choroid plexus, pituitary, circumventricular organs, and cranial motor neurons. The potential clinical implications of these animal findings are unknown. Consider whether the patient is vulnerable to cognitive impairment, such as infants and children who have developing brains, and patients who are cognitively impaired.

Please click here for Rebinyn® Prescribing Information.

Rare Bleeding Disorders
Other Therapy Areas
Explore diabetes
Explore obesity
Explore growth-related disorders
Explore rare bleeding disorders
Explore rare renal disorders
Explore hormone replacement therapy
  • Rare Bleeding Disorders Home
  • Product Information
    Products
    • Our Treatments
      How to Order
      Trial Prescriptions
      Recombinant Manufacturing
    Professional Resources
    • Product Resources Library
      Contact Your Representative
  • Professional Education
    Disease Education
    • Clinical Education Library
      Congenital Hemophilia with Inhibitors
      Breakthrough Bleeds
      Acquired Hemophilia
      Glanzmann's Thrombasthenia
      Interactive Joint Bleed Model
    Treatment Guidelines
    • MASAC Guidelines
      WFH Guidelines
    Additional Resources
    • Organizations & Conferences
  • Patient Support
    Product Education
    • Product Education Materials
    Disease Education
    • Disease Education Resources
    Access & Affordability
    • Prescription Savings & Insurance Support
      ICD-10 Codes for Rare Bleeding Disorders

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Non-US Health Care Professionals, please go to pro.novonordisk.com.

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