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Rebinyn® coagulation factor IX (recombinant), glycoPEGylated logo
Important Safety Information | Patient Site
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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 assistance for patientsa

Novo Nordisk is committed to helping patients. Our services are offered through NovoCare® (previously NovoSecure™), a support network that helps your eligible patients access co-pay savings, product assistance, and more.

aAvailable only for commercially insured patients with an FDA-approved Novo Nordisk product indication. Patients who participate in any government, state, or federally funded medical or prescription benefit programs, 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 for appeal support.


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NovoCare®/NovoSecure™ is designed for patients

Your patients can access:

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

A Novo Nordisk Representative can help you connect patients with these resources. Or you can contact a NovoCare® Specialist by calling 1-844-668-6732.

Send your patients to NovoCare.com    


Insurance coordination

Help with benefits verification

We can help you verify your patient’s benefits with QuickCheck™. Submit the form to receive a Summary of Benefits, generally within 4 hours,b from 9:00 am to 4:00 pm Eastern time.

  1. Download the QuickCheck™ Form
  2. Fax it to NovoCare® at 1-866-488-6576

bQuickCheck™ benefits verification can be completed within 4 hours only if all required information has been submitted.

QuickCheck™ Benefits Verification Form
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QuickCheck™ Benefits Verification Form
The QuickCheck™ form will allow NovoCare® to verify your patients’ benefits and provide additional insurance-related information.
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Prior Authorizations

NovoCare® helps determine whether insurance providers require prior  authorizations and what you will need to submit one.

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Appeals

If initial insurance claims are denied, NovoCare® can assist physicians and qualifying patients through the appeal process.a


Other support options for patients

Eligible patients may be able to save on co-pay costsc or qualify for our product assistance program.d Use the tools below to get started and see how we can help patients along their treatment journey.  

Co-pay Assistance
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Co-pay Assistance
See if your patients are eligible to receive a hemophilia savings card.
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Product Assistance Program
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Product Assistance Program
Download the form to see if your patients qualify for our Product Assistance Program.
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Interim Product Program

Interim Product Program

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

Patient Trial Program

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

Considering Rebinyn® for your patients with hemophilia B?

To learn more about our Patient Trial Program, please call 1-844-668-6732 to speak with a NovoCare® Specialist.
You can also explore ways to help your patients save on prescription costs.

cNovo Nordisk Hemophilia and Rare Bleeding Disorders Copay/Coinsurance Terms and Conditions:
Enrolled patients are eligible for up to $12,000 in co-pay/coinsurance assistance per calendar year for each NNI hemophilia or rare bleeding disorder product. Assistance is retroactive to 60 days. Patients must be commercially insured and may not be participating in any government, state, or federally funded medical or prescription benefit programs, including Medicare, Medicaid, Medigap, VA, DOD, and TRICARE, including patients who participate in a managed Medicaid program or have Medicaid as secondary insurance. Uninsured, cash-paying patients are not eligible to participate. Patients are eligible to receive co-pay/coinsurance assistance on an annual basis (12 months). Offer good only in the USA, Puerto Rico, Guam, Saipan, and Virgin Islands with participating pharmacies and cannot be redeemed at government-subsidized clinics. Void where taxed, restricted, or prohibited by law. The Savings Card is no longer valid for residents of Massachusetts. Patient is responsible for complying with any insurance carrier co-payment disclosure requirements, including disclosing any savings received from this program. Re-confirmation of information may be requested periodically to ensure accuracy of data and compliance with terms. This is not an insurance program. Novo Nordisk reserves the right to rescind, revoke, or amend this offer without notice at any time. Non-medication expenses, such as ancillary supplies or administration-related costs, are not eligible. Must have a current prescription for an FDA-approved indication.

dThe Novo Nordisk Patient Assistance Program (PAP) is administered by NovoCare®. To qualify for the PAP, patients must demonstrate financial need and must have attempted to find alternative reimbursement. Several factors are considered in evaluating financial need, including cost of living, size of household, and burden of total medical expenses. If the applicant qualifies under the PAP guidelines, a limited supply of the requested medication(s) will be shipped to the patient. Patients who qualify for PAP may be eligible to receive the prescribed Novo Nordisk product, for up to 1 year from the approval date. Product limits vary.

ePatients 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 programs, 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.

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

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