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BE READY WITH REBINYN®

Rebinyn® helps you achieve higher factor levels so you can be ready for the unexpected.a

PREVIOUSLY TREATED ADULTS ACHIEVED FACTOR 9 LEVELS IN THE NON-HEMOPHILIA RANGE (GREATER THAN 40%)a

Chart showing the length of time adults taking Rebinyn® prophylaxis spent with Factor 9 levels in the non-hemophilia range
Chart showing the length of time adults taking Rebinyn® prophylaxis spent with Factor 9 levels in the non-hemophilia range

aData represent mean steady-state pharmacokinetic profiles from previously treated adolescent/adult patients with moderate to severe hemophilia B (n=9) taking repeated doses of Rebinyn® 40 IU/kg once weekly. Factor 9 levels were within the non-hemophilia range (greater than 40%) for 5.4 days (approximately 80% of the week).

bBased on the mean steady-state post-dose peak levels and pre-dose trough levels 168 hours after administered Rebinyn® 40 IU/kg once weekly in previously treated patients (20 adult and 9 adolescent patients).

IN ADULTS, THE
HALF-LIFEc WAS

Half-life duration in adults

Factor 9 levels after an infusion were
98% (N=20), and Factor 9 levels
at Day 7 were 29% (N=20).b

IN ADOLESCENTS,
THE HALF-LIFEc WAS

Half-life duration in adolescents

Factor 9 levels after an infusion were
83% (N=9), and Factor 9 levels
at Day 7 were 24%b

IN ADULTS, THE
HALF-LIFEc WAS

Half-life duration in adults

Factor 9 levels after an infusion were
98% (N=20), and Factor 9 levels
at Day 7 were 29% (N=20).b

IN ADOLESCENTS,
THE HALF-LIFEc WAS

Half-life duration in adolescents

Factor 9 levels after an infusion were
83% (N=9), and Factor 9 levels
at Day 7 were 24%b

cHalf-life: Time required for Factor 9 to decline to half its value.

dBased on analysis using a 1-stage assay in patients (n=6) aged 18 and older, the half-life at steady state was 115 hours following once-weekly (40 IU/kg) dosing; in patients (n=3) aged 13 to 17, the half-life at steady state was 103 hours. Following single-dose administration (40 IU/kg) in the same patient population, the half-life was 83 hours (adults) and 89 hours (adolescents). 

MAINTAINING FACTOR LEVELS
BETWEEN DOSES

MAINTAINING FACTOR LEVELS
BETWEEN DOSES

The World Federation of Hemophilia (WFH)e says an extended half-life prophylaxis can allow individuals to keep Factor 9 levels in the non-hemophilia range (greater than 40%) for a significant amount of time.

eWFH offers guidelines that inform shared decision-making between patients, caregivers, and healthcare providers based on data from existing peer-reviewed findings.

Timothy holding his hands

Timothy has severe hemophilia B and uses Rebinyn®.

fData represent mean steady-state pharmacokinetic profiles from previously treated adolescent/adult patients with moderate to severe hemophilia B (n=9) taking repeated doses of Rebinyn® 40 IU/kg once weekly. Factor 9 levels were within the non-hemophilia range (greater than 40%) for 5.4 days (approximately 80% of the week).

HIGHER LEVELS WITH REBINYN® CAN HELP KIDS BE READY FOR THE UNEXPECTED

HIGH FACTOR 9 LEVELS IN CHILDREN 12 YEARS OR YOUNGER

Icons of young children next to a graphic depicting Factor 9 levels after an infusion for this age group
Graphic showing the Rebinyn(R) half-life and Factor 9 levels at Day 7 for young children
Icons of older children next to a graphic depicting Factor 9 levels after an infusion for this age group
Graphic showing the Rebinyn(R) half-life and Factor 9 levels at Day 7 for older children

gMean steady-state pre-dose trough levels and post-dose peak levels across the clinical trials for all previously treated children receiving Rebinyn® 40 IU/kg once weekly. Based on an analysis using a 1-stage assay of previously treated children aged 0 to 12 years old (N=25). Children were stratified into 2 groups: ≤6 years old (n=12) and 7 to 12 years old (n=13). All patients received a fixed dose of 40 IU/kg of Rebinyn® intravenously once weekly for prophylaxis. 

hBased on single-dose pharmacokinetic parameters of Rebinyn® 40 IU/kg in children aged ≤6 (n=12) and 7 to 12 years (n=13). A single-dose pharmacokinetic assessment was conducted after administration of the first dose of Rebinyn®. The last pharmacokinetic sample was collected 1 week later, just prior to administration of the second dose.

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
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INTERESTED IN TRYING REBINYN®?

To learn more about our free trial prescription program, please call 1-844-668-6732 to speak with NovoCare®.
 

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Commercially insured patients only. Eligibility and restrictions apply.

PREVENT BLEEDS
WITH REBINYN®

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

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CONSIDERING A SWITCH?

See how Factor 9 therapies compare on features that matter to you—from storage conditions to infusion time.

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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.