Rare Bleeding Disorders
Other Therapy Areas
Explore diabetes
Explore obesity
Explore rare bleeding disorders
Explore growth-related disorders
Explore hormone replacement therapy
Medical Information | Non-US Health Care Professionals
Account Settings
Sign Out
Sign In | Create Account
  • Rare Bleeding Disorders Home
    • Products
      Our Treatments How to Order Trial Prescriptions Recombinant Manufacturing
    • Professional Resources
      Product Resources Library Contact Your Representative
    • Disease Education
      Clinical Education Library Congenital Hemophilia with Inhibitors Acquired Hemophilia Glanzmann's Thrombasthenia Interactive Joint Bleed Model
    • Treatment Guidelines
      MASAC Guidelines WFH Guidelines
    • Additional Resources
      Organizations & Conferences
    • Product Education
      Product Education Materials
    • Disease Education
      Disease Education Resources
    • Access & Affordability
      Prescription Savings & Insurance Support
  • Sign In
    Create Account
    • Account Settings
    • Sign Out
    Other Therapy Areas
    Medical Information
    Non-US Health Care Professionals
Rebinyn® coagulation factor IX (recombinant), glycoPEGylated logo
Important Safety Information | Patient Site
Prescribing Information
    • How it Works
    • Patient Use Cases
    • Prophylaxis
    • On Demand
    • Perioperative
    • Safety Profile
    • Pharmacokinetics
    • FIX PK Comparisons
    • Comparative Modeling
    • Simplified Dosing
    • Reconstitution & Administration
  • Cost & Coverage
    • Patient Education
    • Education for You
    • How to Order
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
Approved

FOR ONCE-WEEKLY PROPHYLAXIS

Life is about the unexpected


Once-weekly Rebinyn® raises expectations with higher Factor IX (FIX) levels for longer.1,a

  • FIX levels in the non-hemophilia range for most of the week2,b
  • Simple once-weekly dosing3
  • Stops bleeds before they start3
See efficacy data

Timothy has severe hemophilia B and uses Rebinyn®.

aBased upon a phase 1 study of patients administered one of three doses of Rebinyn® (25, 50, or 100 IU/kg) compared with one dose of their prior SHL rFIX (n=7) or pdFIX (n=8) at the same dose using a one-stage assay and product-specific standard. Estimated mean pharmacokinetic (PK) parameters are adjusted to a dose of 50 IU/kg. Incremental recovery at 30 minutes (IR30) and half-life were higher and longer with Rebinyn® than rFIX (IR30 0.0131 vs 0.0068 (IU/mL)/(IU/kg) and half-life 93 vs 19 hours). (All values were statistically significant (P<0.001).) The clinical relevance of these PK differences is unknown.1

bData represent mean steady-state pharmacokinetic profiles from previously treated adolescent/adult patients with moderate to severe hemophilia B (n=9) taking Rebinyn® 40 IU/kg once weekly. Factor IX levels were within the non-hemophilia range (greater than 40%) for 5.4 days (approximately 80% of the week).2

Now available in four vial sizes:

500 IU, 1,000 IU, 2,000 IU, and new 3,000 IU.

See dosing info

Now available in four vial sizes:

500 IU, 1,000 IU, 2,000 IU, and new 3,000 IU.

See dosing info
4 vial sizes

Maintaining FIX levels between doses

The World Federation of Hemophilia (WFH) acknowledges extended half-life FIX products allow for more ambitious prophylaxis by having patients’ FIX levels in a non-hemophilic range (>40%) for a substantial proportion of time.4

With Rebinyn®,
your adult and adolescent
patients can spend

~ 80%

of the dosing interval
with FIX levels above 40%2,b

Clayton has hemophilia B and uses Rebinyn®.


Maintaining FIX levels between doses

The World Federation of Hemophilia (WFH) acknowledges extended half-life FIX products allow for more ambitious prophylaxis by having patients’ FIX levels in a non-hemophilic range (>40%) for a substantial proportion of time.4

With Rebinyn®, your adult and adolescent patients can spend

~ 80%

of the dosing interval with FIX levels above 40%2,b

Raise FIX levels so patients can be ready for the unexpected

98%

Factor IX activity

achieved in adults within the first hour after dosing with Rebinyn®3,c

Arrow pointing up
See the data
See study design
29%

mean Factor IX trough levels

achieved in adults3,c

See PK data
See study design

Timothy lives with hemophilia B.

1

overall median ABR

in adults, meaning your prophylaxis patients could experience powerful bleed protection3,d

Check mark
Review efficacy
See study design
13

years of clinical trial experience5

Safety check list with a vial
Review safety data

ABR=annualized bleed rate.

cBased on the mean steady-state pre-dose trough levels and post-dose peak levels in previously treated patients (20 adults and 9 adolescent patients) 168 hours after administered Rebinyn® 40 IU/kg once weekly.3

dABR of 1 was based on statistical calculation of median ABR for total bleeds in adult patients.6

In a retrospective, observational, real-world study of 42 patients, fewer bleeds were observed in patients who switched to Rebinyn®7

Data from the Canadian Bleeding Disorders Registry

See study design

Mean intrapatient ABR when switching from Alprolix® to Rebinyn® prophylaxis

Graph displaying intrapatient ABR for Rebinyn® vs Alprolix®

Mean intrapatient ABR when switching from BeneFIX® to Rebinyn® prophylaxis

Graph displaying intrapatient ABR for Rebinyn® vs BeneFIX®
One time

Simple

once-weekly prophylaxis dosing3

See details
40

IU/kg

for all ages

Adjust dosing regimen based on individual patient’s bleeding pattern, and physical activity.

Have questions about Rebinyn®?

Rebinyn® packaging

Patient Trial Program

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.

Study designs

Medicine vial icon

Collins et al (2014)8
paradigm 2: pivotal phase 3 trial in adults and adolescents

Patients: 74 male patients aged 13 to 70 years with hemophilia B. Patients had FIX activity ≤2 IU/dL, no history of inhibitors to FIX, and at least 150 exposure days to any FIX product.

Study design: Patients were selected for prophylaxis or on-demand treatment at screening. On-demand patients participated in the trial for 28 weeks and received a single dose of 40 IU/kg for bleeding episodes (80 IU/kg for severe bleeding episodes). Prophylaxis patients participated for 52 weeks. Prophylaxis patients were randomly divided into groups of 10 IU/kg once weekly and 40 IU/kg once weekly. Patients were blinded to the prophylaxis dose. The investigator was blinded but could become unblinded if it became necessary to measure a patient’s FIX activity. A pharmacokinetic assessment of the two prophylactic doses was conducted using a subset of these patients. Pharmacokinetic assessments were based on a 1-stage clotting assay and performed at trial initiation (single dose assessments) and after 12 to 44 weeks of prophylaxis (steady state assessments) with both trial doses. The assessments included 7 sampling points up to 168 hours post injection.

Primary endpoint: Safety of Rebinyn®, measured by factors including development of FIX inhibitors (per Nijmegan modified Bethesda assay), adverse events, noninhibitory binding antibodies against Rebinyn®, and antibodies against host cell proteins.

Secondary endpoints: Efficacy and prophylactic effect of Rebinyn® when treating spontaneous or traumatic bleeding episodes. Assessment included number of doses, amount of product used, duration of bleed, and annual bleed rate.

Young et al (2017)6
paradigm 4: phase 3 safety and efficacy extension trial

Patients: 71 male patients who had completed either the paradigm 2 or paradigm 3 clinical trials. Patients were aged 13 to 70 years with hemophilia B and had FIX activity ≤2 IU/dL, no history of inhibitors to FIX, and at least 150 exposure days to any FIX product.

Study design: Open-label, non-randomized, multicenter trial with four treatment arms: three once-weekly prophylactic groups (10 IU/kg, 40 IU/kg, and 80 IU/kg) and one on-demand group (40 IU/kg for mild and moderate bleeds, 80 IU/kg for severe bleeds). All patients were expected to have at least 50 additional exposure days to Rebinyn® during this extension trial. Treatment was mostly administered at home, with 2 clinic visits in the first 6 months and once every 6 months following. Prophylaxis patients received treatment during clinic visits, to allow pre-dose and post-dose blood samples and assessments.

Primary endpoint: Development of FIX inhibitors.

Secondary endpoints: Efficacy and prophylactic effect of Rebinyn® when treating spontaneous or traumatic bleeding episodes. Assessment included number of bleeds and FIX activity.

Matino et al (2022)7
Switching to nonacog beta pegol in hemophilia B: Outcomes from a Canadian real-world, multicenter, retrospective study

Patients: Study included 97 Canadian patients with hemophilia B and treated with Rebinyn® prophylaxis for at least 6 months. Patients spanned all age groups and severity of hemophilia B. Secondary endpoint analysis included only those patients (n=42) with at least 6 months of data recorded with a previous product before switching to Rebinyn®.

Design: Retrospective analysis of data reported to the Canadian Bleeding Disorders Registry (CBDR) by 11 hemophilia treatment centers from April 2021 through March 2021. Two study groups, patients previously treated with Alprolix® and patients previously treated with BeneFIX®, were analyzed using negative binomial regression, to compare bleed rates, and a shared frailty gamma model, to compare recurrent bleeding incidents. CBDR formulary mandated a switch from Alprolix® to Rebinyn®, and patients had the option to switch from BeneFIX® to Rebinyn®.

Primary endpoint: Efficacy of Rebinyn® prophylaxis, including annualized bleeding rate, bleeding frequency in target joints, and target joint progression.

Secondary endpoint: Change in efficacy metrics and number of infusions required to treat a bleeding episode when patients switched to Rebinyn® from a previous FIX product.

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.

References:

  1. Negrier C, Knobe K, Tiede A, et al. Enhanced pharmacokinetic properties of a glycoPEGylated recombinant factor IX: a first human dose trial in patients with hemophilia B. Blood. 2011;118(10):2695-2701.
  2. Tiede A, Abdul-Karim F, Carcao M, et al. Pharmacokinetics of a novel extended half-life glycoPEGylated factor IX, nonacog beta pegol (N9-GP) in previously treated patients with haemophilia B: results from two phase 3 clinical trials. Haemophilia. 2017;23(4):547-555.
  3. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2022.
  4. Srivastava A, Santagostino E, Dougall A, et al. WFH guidelines for the management of hemophilia. Haemophilia. 2020;26(suppl 6):1-158.
  5. Novo Nordisk A/S. Safety of 40K PEGylated recombinant Factor IX in non-bleeding patients with haemophilia B. ClinicalTrials.gov identifier: NCT00956345. Updated January 20, 2017. Accessed June 3, 2022. https://clinicaltrials.gov/ct2/show/NCT00956345
  6. Young G, Collins PW, Colberg T, et al. Nonacog beta pegol (N9-GP) in haemophilia B: a multinational phase III safety and efficacy extension trial (paradigm 4). Thromb Res. 2016;141:69-76.
  7. Matino D, Iorio A, Keepanasseril A, et al. Switching to nonacog beta pegol in hemophilia B: outcomes from a Canadian real-world, multicenter, retrospective study. Res Pract Thromb Haemost. 2022;6(3):e12661.
  8. 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.
Rare Bleeding Disorders
Other Therapy Areas
Explore diabetes
Explore obesity
Explore rare bleeding disorders
Explore growth-related 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
      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

NovoCare® and Rebinyn® are registered trademarks and novoMEDLINK™ is a trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
Non-US Health Care Professionals, please go to pro.novonordisk.com.

Legal Notice | Privacy Policy | Cookie Policy | Contact Us |
novonordisk-us.com    
© 2023 Novo Nordisk All rights reserved. US22REB00204 March 2023

Quick links

Trial prescription programs

Patient access and affordability options

MASAC treatment guidelines

Patient educational materials