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PROTECT MORE MOMENTS WITH REBINYN®

Once-weekly Rebinyn® delivers high Factor 9 activity and provides long-term bleed protection so that you can prepare for the unexpected.a,b

Timothy smiling

aFrom a phase 3, open-label trial assessing the safety and efficacy of Rebinyn® after long-term exposure (up to 3 years) in 71 previously treated patients (aged 13 to 70) from paradigm 2 or 3.

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, 9 adolescent, and 25 pediatric patients). 

THE NON-HEMOPHILIA RANGE

THE NON-HEMOPHILIA RANGE

The World Federation of Hemophilia (WFH)c 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.

cWFH 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®.

dData represent mean steady-state pharmacokinetic profiles from previously treated adolescent/adult patients with moderate to severe hemophilia B (n=9) taking 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).

REBINYN® PROPHYLAXIS HELPS PREVENT BLEEDS BEFORE THEY START

LOW ABR IN ADULTS AND ADOLESCENTS

Average annual bleeds per year in adults and number of spontaneous, traumatic and joint annual bleeds in adultsn
Average annual bleeds per year in adults
Number of spontaneous, traumatic or joint annual bleeds in adults

PROTECT TARGET JOINTS

Percentage of target joints that were no longer classified as target joints

ABR=annualized bleeding rate.

eFrom a phase 3, open-label trial assessing the safety and efficacy of Rebinyn® after long-term exposure (up to 3 years) in 71 previously treated patients (aged 13 to 70) from paradigm 2 or 3.

f20 target joints were reported in 13 patients in the 40 IU/kg once weekly arm at baseline, and 18 out of 20 (90%) of these target joints were considered resolved at the end of the main phase. There were 2 target joints at the start of the extension trial in patients in the 40 IU/kg once-weekly arm. Upon conclusion of the extension phase, both of these target joints were resolved, as measured by International Society on Thrombosis and Haemostasis (ISTH) target joint criteria. The definition of target joint from the ISTH is greater than or equal to 3 spontaneous bleeds into the joint within a consecutive 6-month period. When there have been less than or equal to 2 bleeds into the joint within a consecutive 12-month period, the joint is no longer considered a target joint.

WITH REBINYN® PROPHYLAXIS, CHILDREN 12 AND UNDER ACHIEVED A YEARLY BLEED RATE OF:g

6 years and under (n=12)

Number of traumatic bleeds
Number of spontaneous bleeds
Number of joint bleeds

7 to 12 years (n=13)

Number of traumatic bleeds
Number of spontaneous bleeds
Number of joint bleeds

g25 previously treated children 0 to 12 years old received routine prophylactic administration of Rebinyn® 40 IU/kg once weekly for 52 week.

DID YOU KNOW?

Rebinyn® prophylaxis only needs to be taken once per week. Simple dosing may be easier to remember and fit into your routine.h

hDosing regimen may be adjusted based on individual patient’s bleeding pattern, and physical activity.

Rebinyn® prophylaxis fact

SIMPLIFIED DOSING -
FLEXIBLE STORAGE

Rebinyn® offers simple, once-weekly dosing, and flexible storage.

Syringe

CHOOSING THERAPIES

See Rebinyn® PK compared to other therapies

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STAY IN THE KNOW

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STAY IN THE KNOW

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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.