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TAKE CONTROL WITH HIGH FACTOR LEVELS

Rebinyn® is proven to achieve and maintain higher factor levels.a

elevated factor immediate, elevated factor sustained 7 days
average half life adult

aBased upon a phase 1 study comparing 25, 50, and 100 IU/kg doses of Rebinyn® to a 50 IU/kg dose of standard half-life rFIX in 7 adults and a 50 IU/kg dose of plasma-derived FIX in 8 adults. For Rebinyn®, estimated average FIX activity is adjusted to a dose of 50 IU/kg.
bIn two phase 3 studies, factor levels were evaluated for 1 week after the first dose of Rebinyn® 40 IU/kg. The average levels after 7 days were 16.8% in 6 adults, 14.6% in 3 adolescents, 10.9% in 13 children ages 7 to 12 years, and 8.4% in 12 children up to age 6 years. 
cBased upon a 2.34% increase in factor levels per IU/kg infused in adults.

factor coverage 7 days

Half-life is the time it takes for the level of factor in the blood to fall by half (50%).

HIGH FACTOR ACTIVITY IN CHILDREN AND ADOLESCENTS

A single dose of Rebinyn® 40 IU/kg was shown to elevate factor levels above their normal levels in pediatric patients.d Take a look at the numbers:

Emili and son with hemophilia b
child infusion statistics chart
child infusion statistics chart
adolescent infusion statistics chart

dBased on pharmacokinetic assessment of a single dose of Rebinyn® 40 IU/kg after 7 days in 3 adolescents (mean FIX activity 14.6%), 13 children aged 7 to 12 (mean FIX activity 10.9%), and 12 children aged 0-6 (mean FIX activity 8.4%) upon enrollment in the phase 3 trials using 1-stage assay and product-specific standard. All values are geometric mean. 
eBased upon a 1.51% increase in factor levels per IU/kg infused in children aged ≤6. 
fBased upon a 1.59% increase in factor levels per IU/kg infused in children aged 7-12. 
gBased upon a 1.96% increase in factor levels per IU/kg infused in adolescents aged 13-17.

rebinyn package

INTERESTED IN TRYING REBINYN®?

To learn more about our free trial prescription program, please call 1-844-668-6732 to speak with a NovoSecure™ Specialist.h

rebinyn package

hPatients 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.

DESIGNED WITH SAFETY IN MIND

In clinical studies, Rebinyn® was shown to be safe and effective.

three rebinyn vials

CONSIDERING A SWITCH?

See how Factor IX therapies compare on features that matter to you—from storage conditions to infusion time.

switch factor 9 therapy

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STAY IN THE KNOW. SIGN UP TO GET THE LATEST UPDATES ON REBINYN®

Selected Important Safety Information

What is the most important information I need to know about Rebinyn®?

  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center. Carefully follow your healthcare provider’s instructions regarding the dose and schedule for infusing Rebinyn®.

Who should not use Rebinyn®?
Do not use Rebinyn® if you:

  • are allergic to Factor IX or any of the other ingredients of Rebinyn®.
  • are allergic to hamster proteins.
     

Indications and Usage

What is Rebinyn® Coagulation Factor IX (Recombinant), GlycoPEGylated?
Rebinyn® is an injectable medicine used to replace clotting Factor IX that is missing in patients with hemophilia B. Rebinyn® is used to treat and control bleeding in people with hemophilia B. Your healthcare provider may give you Rebinyn® when you have surgery. Rebinyn® is not used for routine prophylaxis or for immune tolerance therapy.
 

Important Safety Information

What is the most important information I need to know about Rebinyn®?

  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center. Carefully follow your healthcare provider’s instructions regarding the dose and schedule for infusing Rebinyn®.

Who should not use Rebinyn®?
Do not use Rebinyn® if you:

  • are allergic to Factor IX or any of the other ingredients of Rebinyn®.
  • are allergic to hamster proteins.

What should I tell my healthcare provider before using Rebinyn®?
Tell your healthcare provider if you:

  • have or have had any medical conditions.
  • take any medicines, including non-prescription medicines and dietary supplements.
  • are nursing, pregnant, or plan to become pregnant.
  • have been told you have inhibitors to Factor IX.

How should I use Rebinyn®?

  • Rebinyn® is given as an infusion into the vein.
  • Call your healthcare provider right away if your bleeding does not stop after taking Rebinyn®.
  • Do not stop using Rebinyn® without consulting your healthcare provider.

What are the possible side effects of Rebinyn®?

  • Common side effects include swelling, pain, rash or redness at the location of the infusion, and itching.
  • Call your healthcare provider right away or get emergency treatment right away if you get any of the following signs of an allergic reaction: hives, chest tightness, wheezing, difficulty breathing, and/or swelling of the face.
  • Tell your healthcare provider about any side effect that bothers you or that does not go away.
  • Animals given repeat doses of Rebinyn® showed Polyethylene Glycol (PEG) inside cells lining blood vessels in the choroid plexus, which makes the fluid that cushions the brain. The potential human implications of these animal tests are unknown.
     

Please click here for Prescribing Information.

Rebinyn® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.