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Consider a treatment that has 5x longer half-life.

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In another study, repeat doses of Rebinyn achieved a 115-hour half-life in adults

> > Why It Matters

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Consider a treatment that has 5x longer half-life.

When your phone has more charge, it can last longer—which could mean…

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In another study, repeat doses of Rebinyn achieved a 115-hour half-life in adults

So, what does 5x longer half-life mean for your Factor 9 therapy?

Rebinyn® provides 5x longer half-life than BeneFIX®. "Half-life" is the time it takes for the level of factor in the blood to decrease by half (50%). A single dose of Rebinyn® decreases by half in 93 hours while BeneFIX® decreases by half in 19 hours.a

A bar chart comparing the extended half-life of Rebinyn® with the shorter half-life of BeneFix®. Chart.

See How Rebinyn® Compares

aPhase 1 trial comparing PK of Rebinyn® with SHL Factor 9 products. Based upon a phase 1 study of patients administered 1 of 3 doses of Rebinyn® (25, 50, or 100 IU/kg) compared with 1 dose of their prior SHL rFIX (n=7) or pdFIX (n=8) at the same dose using a 1-stage assay. Estimated mean PK parameters are adjusted to a dose of 50 IU/kg. Differences were similar in comparison of Rebinyn® to pdFIX (half-life 93 vs 18 hours, 5.2x, P<0.001; AUC 70 vs 9 U x h/mL, 8x, P<0.001) and in comparison of Rebinyn® to rFIX (half-life 93 vs 19 hours, P<0.001; AUC 72 vs 7 U x h/mL, P<0.001). The clinical relevance of these pharmacokinetic differences is unknown.

In another study, Rebinyn® once weekly achieved an 115-hour average half-life in adultsb

bBased upon a phase 3 study in 6 adults and 3 adolescents who received a once-weekly prophylactic treatment of Rebinyn® 40 IU/kg.

So, what does 5x longer half-life mean for your Factor 9 therapy?

Rebinyn® provides 5x longer half-life than BeneFIX®. "Half-life" is the time it takes for the level of factor in the blood to decrease by half (50%). A single dose of Rebinyn® decreases by half in 93 hours while BeneFIX® decreases by half in 19 hours.a

Rebinyn® and BeneFIX comparison

See How Rebinyn® Compares

aPhase 1 trial comparing PK of Rebinyn® with SHL Factor 9 products. Based upon a phase 1 study of patients administered 1 of 3 doses of Rebinyn® (25, 50, or 100 IU/kg) compared with 1 dose of their prior SHL rFIX (n=7) or pdFIX (n=8) at the same dose using a 1-stage assay. Estimated mean PK parameters are adjusted to a dose of 50 IU/kg. Differences were similar in comparison of Rebinyn® to pdFIX (half-life 93 vs 18 hours, 5.2x, P<0.001; AUC 70 vs 9 U x h/mL, 8x, P<0.001) and in comparison of Rebinyn® to rFIX (half-life 93 vs 19 hours, P<0.001; AUC 72 vs 7 U x h/mL, P<0.001). The clinical relevance of these pharmacokinetic differences is unknown.

In another study, Rebinyn® once weekly achieved a 115-hour average half-life in adultsb

bBased upon a phase 3 study in 6 adults and 3 adolescents who received a once-weekly prophylactic treatment of Rebinyn® 40 IU/kg.

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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.