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TAKE CONTROL WITH REBINYN® ON DEMAND

Rebinyn® elevates factor above your normal levels.a

Abdiel lives with hemophilia b and uses rebinyn®.

aIn a pharmacokinetic assessment of a single dose of Rebinyn® 40 IU/kg upon enrollment in 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 aged 7 to 12 years, and 8.4% in 12 children up to age 6 years. 

EXPERIENCE HIGH FACTOR LEVELS

With a single dose of Rebinyn® 40 IU/kg, adults with less than or equal to 2% Factor 9 levels experienced:

Percentage of factor levels achieved after an infusion and Percentage of mean factor levels sustained
Percentage of factor levels achieved after an infusion
Percentage of mean factor levels sustained

bBased upon a 2.34% increase in factor levels per IU/kg infused in adults receiving a single dose of Rebinyn® 40 IU/kg.

A single dose of Rebinyn® 40 IU/kg was shown to elevate factor levels above their normal levels in pediatric patients.b

In children up to
6 years of age

Statistic on factor levels in children up to 6 years of age

In children ages
7-12 years

Statistic on factor levels in children ages 7-12 years

In adolescents ages
13-17 years

Statistic on factor levels in adolescents ages 13-17

bBased 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.
cBased upon a 1.51% increase in factor levels per IU/kg infused in children aged ≤6 receiving a single dose of Rebinyn® 40 IU/kg.
dBased upon a 1.59% increase in factor levels per IU/kg infused in children aged 7-12 receiving a single dose of Rebinyn® 40 IU/kg.
eBased upon a 1.96% increase in factor levels per IU/kg infused in adolescents aged 13-17 receiving a single dose of Rebinyn® 40 IU/kg.

Average half-life in adults at 3.5 days

Timothy has severe hemophilia B and uses Rebinyn®.

Timothy smiling on a sailing boat
Average half-life in adults at 3.5 days

DID YOU KNOW?

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

Half-life fact

LOOKING FOR RELIABILITY IN YOUR FACTOR 9 TREATMENT?

A study of adults and adolescents with hemophilia B showed that Rebinyn® on demand treated 98% of bleeds with 1-2 infusions.f In another study, bleed control was rated successful (defined as excellent or good) in 95% of 142 bleeding episodes.g

Percentage of bleeds treated with 1-2 infusions and Percentage of hemophilia B patients that rated their bleed control as successful
Percentage of bleeds treated with 1-2 infusions
Percentage of hemophilia B patients that rated their bleed control as successful

fResults shown are from the on-demand arm of the adolescent/adult clinical study in previously treated patients. In this study, 15 people were treated for on-demand bleeds. In 14 people, there were a total of 143 bleeding episodes. 

gResults shown are based on a bleed assessment by either the patient (for home treatment) or the study investigator (for treatment under medical supervision). Bleeds were assessed using a 4-point scale of excellent, good, moderate, or poor.

Markus looking off into the distance

PROTECTION IN SURGERY

Rebinyn® successfully protected patients from bleeds during all major surgeries studied.

Learn About the Surgery Success Rate

PREVENT BLEEDS
WITH PROPHYLAXIS

Learn what once-weekly Rebinyn® can do for you.

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    See the Details    

HOW IT EXTENDS HALF-LIFE

Rebinyn® uses technology that helps it stay in your body longer, to protect you longer. 

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   Learn How It Works    

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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, prevent, or reduce the frequency (number) of bleeding episodes in people with hemophilia B. Your healthcare provider may give you Rebinyn® when you have surgery. Rebinyn® is not used 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 infusion site reaction (bruising, bleeding, swelling, pain, or redness), itching, and rash.
  • Your body can also make antibodies called “inhibitors” against Factor IX, including Rebinyn®, which may stop Rebinyn® from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time.
  • Call your healthcare provider right away or get emergency treatment right away if you get, for example, any of the following signs of an allergic reaction: hives, chest tightness, wheezing, difficulty breathing, and/or swelling of the face.
  • You may be at an increased risk of forming blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider if you have chest pain, difficulty breathing, leg tenderness, or swelling.
  • Animals given repeat doses of Rebinyn® showed Polyethylene Glycol (PEG) in certain cells in 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.