Unlike other FIX products, with Rebinyn® there’s no need to calculate desired FIX activity levels when determining the appropriate dose.1-6

Clayton lives with hemophilia B and hikes
Clayton lives with hemophilia B and hikes

Unlike other FIX products, with Rebinyn® there’s no need to calculate desired FIX activity levels when determining the appropriate dose.1-6

Clayton lives with hemophilia B and hikes
Clayton lives with hemophilia B and hikes

The recommended dose for all patients is:

for minor or moderate bleeds1,a

for minor or moderate bleeds1,a

80 IU/kg for major bleeds1,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. 

Dosing Chart for perioperative management

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

Rebinyn dosage labels
Rebinyn dosage labels

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

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. 

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. 

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. 

Vial icon

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.

ESTABLISHED SAFETY PROFILE

Yellow test tubes

Clinical trials showed 0 inhibitors and thrombotic events confirmed in previously treated patients.1

RECONSTITUTE IN JUST

A FEW STEPS

MixPro® reconstitution & administration

With MixPro®, it’s as quick as attach, twist, and mix.1

ESTABLISHED SAFETY PROFILE

Clinical trials showed 0 inhibitors and thrombotic events confirmed in previously treated patients.1

RECONSTITUTE IN JUST A FEW STEPS

With MixPro®, it’s as quick as attach, twist, and mix.1

REGISTER TO GET THE LATEST UPDATES ON REBINYN®

Website link

REGISTER TO GET THE LATEST UPDATES ON REBINYN®

Selected 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.

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 Prescribing Information.

References:

  1. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; May 2017.
  2. Alprolix [package insert]. Cambridge, MA: Biogen Inc; 2017.
  3. Rixubis [package insert]. Westlake Village, CA: Baxalta Healthcare Corporation; 2016.
  4. Idelvion [package insert]. Kankakee, IL: CSL Behring LLC; 2017.
  5. Ixinity [package insert]. Berwyn, PA: Aptevo BioTherapeutics LLC; 2016.
  6. Benefix [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals, Inc; 2015.