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. Not for immune tolerance induction.
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Recommended dose for routine prophylaxis1
Simple once-weekly dosing helps patients maintain high FIX levels and be ready for the unexpected.1
weekly dosing
IU/kg
Dosing regimen can be adjusted based on individual patient’s bleeding pattern and physical activity.
Almost two-thirds of patients taking extended half-life therapies use once-weekly dosing regiments.7,a
aBased on American Thrombosis and Hemostasis Network (ATHN) Dataset, the proportion of subjects with severe hemophilia on prophylaxis were compared to those on demand by age cohort in June 2018 and March 2019. The proportion of subjects on prophylaxis was analyzed by race, ethnicity, insurance status, and hemophilia treatment center region. Treatment frequency for subjects receiving prophylaxis with extended half-life (EHL) was analyzed.7
Flexible bleed control with on-demand dosing
IU/kg
for minor or moderate bleeds1
IU/kg
for major bleeds1
A single dose of 40 IU/kg should be sufficient for minor and moderate bleeds. For major bleeds, treat with 80 IU/kg. For all bleed types, additional doses of 40 IU/kg can be given.1
Dosing for perioperative management1
Type of Surgical Procedure
Recommended dose
Additional information
Type of Surgical Procedure
Minor
For example: Implanting pumps in subcutaneous tissue, skin biopsies, or simple dental procedures.
Recommended dose
40 IU/kg1
Additional information
A single pre-operative dose should be sufficient. Additional doses can be given if needed.
Type of Surgical Procedure
Major
For example: Body cavity is entered, mesenchymal barrier is crossed, fascial plane is opened, organ is removed, and normal anatomy is operatively altered.
Recommended dose
80 IU/kg1
Additional information
Pre-operative dose.
Recommended dose
40 IU/kg1
Additional information
As clinically needed for the perioperative management of bleeding, repeated doses of 40 IU/kg (in 1- to 3-day intervals) within the first week after major surgery may be administered.
Due to the long half-life of Rebinyn®, the frequency of dosing in the post-surgical setting may be extended to once weekly after the first week until bleeding stops and healing is achieved.
Select features of FIX products1-6
The above table is not intended to be a comparison of efficacy or safety.
LabCorp™ partnership helps you monitor FIX levels
Factor IX activity assay results may be significantly affected by the type of aPTT reagent, which can result in over- or under-estimation of FIX activity. Rebinyn® FIX activity levels and inhibitor testing are available through the Novo Nordisk Lab Program, using validated assays in compliance with CAP/CLIA regulations.
To activate your Labcorp™ account and participate in the program, download and complete the form, then email it to fixsupport@labcorp.com.
Flexible storage for patients on-the-go
Rebinyn® does not require refrigeration. It can be stored at room temperature (up to 86˚F) for up to 6 months and for up to 4 hours after reconstitution.
Requires no refrigeration up to 86˚F.1
Room temperature stable
Post-reconstitution storage
If you choose to store Rebinyn® at room temperature, do not return it to the refrigerator. Rebinyn® vials can also be stored in the refrigerator at 36˚F–46˚F for up to 24 months or until the expiration date stated on the label. Please see Prescribing Information for complete storage instructions.
What does Rebinyn® offer patients like Landen?
Landen is 31, lives with moderate hemophilia B, and leads a busy lifestyle—including frequent travel for work. Explore the features of Rebinyn® that may make it an appropriate factor IX therapy for him.
For illustrative purposes.
Established safety profile
Clinical trials showed 0 inhibitors and thrombotic events in previously treated patients in 5 clinical trials over 13 years.1,8
The formation of inhibitors (neutralizing antibodies) to Factor IX (FIX) has occurred following Rebinyn®. Common adverse reactions (≥1%) in previously untreated patients reported in clinical trials included FIX inhibitors.
Powerful bleed protection
Studies show Rebinyn® prophylaxis helps prevent spontaneous and traumatic bleeds.1
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.
- 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.
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 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.
- 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.
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.
References:
- Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- Benefix [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals, Inc; 2022.
- Alprolix [package insert]. Cambridge, MA: Biogen Inc; 2023.
- Idelvion [package insert]. Kankakee, IL: CSL Behring LLC; 2023.
- Ixinity [package insert]. Berwyn, PA: Aptevo BioTherapeutics LLC; 2024.
- Rixubis [package insert]. Westlake Village, CA: Baxalta Healthcare Corporation; 2023.
- Malec LM, Cheng D, Witmer CM, et al. The impact of extended half-life factor concentrates on prophylaxis for severe hemophilia in the United States. Am J Hematol. 2020;95(8):960-965.
- 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