80 IU/kg for major bleeds1,a
SIMPLIFIED FACTOR IX DOSING
Unlike other FIX products, with Rebinyn® there’s no need to calculate desired FIX activity levels when determining the appropriate dose.1-6
SIMPLIFIED FACTOR IX 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
for minor or moderate bleeds1,a
Minor to moderate bleeds can usually be treated with a single 40 IU/kg dose. For major bleeds, doses can be increased to 80 IU/kg.1,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
Minor Surgical Procedure
For example: Implanting pumps in subcutaneous tissue, skin biopsies or simple dental procedures.
Recommended dose:
40 IU/kg1,b
A single pre-operative dose should be sufficient. Additional doses can be given if needed.
Major Surgical Procedure
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
Pre-operative dose.
Recommended dose:
40 IU/kg1,d
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.
MULTIPLE VIAL SIZES
Rebinyn® is available as a white lyophilized powder in single-use vials. Color-coded vial caps differentiate the dose strengths.1
MULTIPLE VIAL SIZES
Rebinyn® is available as a white lyophilized powder in single-use vials. Color-coded vial caps differentiate the dose strengths.1
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.1,e
Requires no refrigeration up to 86˚F.1,e
Room temperature stable
Post-reconstitution storage
Room temperature stable
Post-reconstitution storage
eIf 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.
COMPARISON OF FIX PRODUCTS1-6
As of June 2018, Rebinyn®, BeneFIX, and Ixinity are not approved for routine prophylaxis.
The above table does not imply that one FIX product is more effective than another product.
REBINYN® TRIAL PROGRAM
Considering Rebinyn® for your patients with hemophilia B? Get a 1-month trial prescription for qualifying patients.f
To learn more about our trial prescription program, please call 1-844-NOVO-SEC (1-844-668-6732) to speak with a NovoSecure™ Specialist.
fPatients 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 program, 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.
REBINYN® TRIAL PROGRAM
Considering Rebinyn® for your patients with hemophilia B? Get a 1-month trial prescription for qualifying patients.f
To learn more about our trial prescription program, please call 1-844-NOVO-SEC (1-844-668-6732) to speak with a NovoSecure™ Specialist.
fPatients 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 program, 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.
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.
Please see Prescribing Information for complete monitoring information.
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Novo Nordisk Lab Program Form
This form will enable health care professionals and institutions to activate their Labcorp account to participate in the Novo Nordisk Lab Program. After completing the form, email it to fixsupport@labcorp.com.
ESTABLISHED SAFETY PROFILE
Clinical trials showed 0 inhibitors and thrombotic events confirmed in previously treated patients.1
EFFECTIVE BLEED CONTROL
Clinical trials show the efficacy of Rebinyn® in controlling bleeds.1
ESTABLISHED SAFETY PROFILE
Clinical trials showed 0 inhibitors and thrombotic events confirmed in previously treated patients.1
EFFECTIVE BLEED CONTROL
Clinical trials show the efficacy of Rebinyn® in controlling bleeds.1
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