Rebinyn® is the only factor IX with simplified dosing
Unlike other FIX products, with Rebinyn® there’s no need to calculate desired FIX activity levels when determining the appropriate dose.1-6
Rebinyn® is the only factor IX with simplified dosing
Unlike other FIX products, with Rebinyn® there’s no need to calculate desired FIX activity levels when determining the appropriate dose.1-6
The recommended dose for all patients is:
for minor or moderate bleeds1,a
80 IU/kg for major bleeds1,a
Minor to moderate bleeds can usually be treated with a single 40 IU/kg dose.a For major bleeds, doses can be increased to 80 IU/kg.a
aA single dose should be sufficient for minor and moderate bleeds. Additional doses of 40 IU/kg can be given.
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,b
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, normal anatomy is operatively altered.
Recommended dose
80 IU/kg1,c
Additional information
Pre-operative dose.
Recommended dose
40 IU/kg1,d
Additional information
As clinically needed for the perioperative management of bleeding, repeated doses of 40 IU/kg (in 1-3 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.
bA single pre-operative dose should be sufficient. Additional doses of 40 IU/kg can be given.
cPre-operative dose. Repeated doses of 40 IU/kg (in 1–3 day intervals) within the first week after major surgery may be administered.
dPlease see Prescribing Information for complete instructions.
Select features of FIX products1-6
As of November 2021, Rebinyn® is not approved for routine prophylaxis.
The above table does not imply that one FIX product is more effective than another product.
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.
Factor IX monitoring
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 is 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.
What does Rebinyn® offer patients like Chris?
Chris 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.
Please see Prescribing Information for complete monitoring information.
Multiple vial sizes
Rebinyn® is available as a white lyophilized powder in single-use vials. Color-coded vial caps differentiate the dose strengths.1
Established safety profile
Clinical trials showed 0 inhibitors and thrombotic events in previously treated patients.1
Rebinyn® trial prescription program
Considering Rebinyn® for your patients with hemophilia B?
To learn more about our trial prescription program, please call 1-844-668-6732 to speak with a NovoSecure™ Specialist.
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, 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 Rebinyn® Prescribing Information.
Reference:
- Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2020.
- Benefix [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals, Inc; 2021.
- Alprolix [package insert]. Cambridge, MA: Biogen Inc; 2018.
- Idelvion [package insert]. Kankakee, IL: CSL Behring LLC; 2020.
- Ixinity [package insert]. Berwyn, PA: Aptevo BioTherapeutics LLC; 2021.
- Rixubis [package insert]. Westlake Village, CA: Baxalta Healthcare Corporation; 2020.