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NOW APPROVED

FOR ONCE-WEEKLY

PROPHYLAXIS

To prevent or reduce the number of bleeding episodes in people with hemophilia B

Be ready for the unexpected

Once-weekly Rebinyn® helps you keep Factor 9 levels higher for longer.a

NOW APPROVED

FOR ONCE-WEEKLY
PROPHYLAXIS

To prevent or reduce the number of bleeding episodes in people with hemophilia B

BE READY FOR THE
UNEXPECTED

Once-weekly Rebinyn® helps
you keep Factor 9 levels higher for longer.a

aRebinyn® achieved and maintained higher factor levels than rFIX based upon a phase 1 study comparing 25, 50, and 100 IU/kg single doses of Rebinyn® to a 50 IU/kg single 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 Factor 9 activity is adjusted to a dose of 50 IU/kg. Incremental recovery at 30 minutes (IR30) and half-life were higher and longer with Rebinyn® than rFIX (IR30 0.0131 vs 0.0068 (IU/mL)/(IU/kg) and half-life 93 vs. 19 hours). The clinical relevance of these PK differences is unknown. Incremental recovery is the increase in plasma concentration per IU/kg of factor administered. Half-life is the time it takes for the level of factor in the blood to fall by half (50%).


1x

SIMPLE ONCE-WEEKLY DOSING FOR ROUTINE PROPHYLAXIS:

40 IU/kg for all ages

SIMPLE ONCE-WEEKLY DOSING FOR ROUTINE PROPHYLAXIS:

40 IU/kg for all ages

Your doctor may adjust your dosing regimen based on your bleeding pattern and physical activity.

MAINTAINING FACTOR LEVELS BETWEEN DOSES

>40% range

The World Federation of Hemophilia (WFH)b says an extended half-life treatment can help individuals to keep Factor 9 levels in the non-hemophilia range (greater than 40%) in between doses for most of the time.

The World Federation of Hemophilia (WFH)b says an extended half-life treatment can help individuals to keep Factor 9 levels in the non-hemophilia range (greater than 40%) in between doses for most of the time.

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

REBINYN® HELPS YOU ACHIEVE HIGH FACTOR LEVELS SO YOU
CAN BE READY FOR THE UNEXPECTED

Rebinyn® once-weekly helped previously treated adults spend more time with Factor 9 levels in the non-hemophilia range (greater than 40%)c

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

cData 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). 

dBased on the mean steady-state pre-dose trough levels and post-dose peak levels 30 minutes after infusion in previously treated patients (20 adults and 9 adolescent patients) 168 hours after administered Rebinyn® 40 IU/kg once weekly.

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

fBased on analysis using a 1-stage assay in patients N=6, age ≥18 the half-life at steady state was 115 hours following once-weekly (40 IU/kg) dosing, in patients N=3, age 13-17 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).

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

HIGH FACTOR 9 LEVELS IN CHILDREN 12 YEARS OR YOUNGER

Ages 0-6
n=12

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

Ages 7-12
n=13

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 (12 children aged 0-6 years and 13 children aged 7-12 years) receiving Rebinyn® 40 IU/kg once weekly.

hBased on single-dose pharmacokinetic parameters of Rebinyn® 40 IU/kg in 25 previously treated children aged 0-6 years (n=12) and 7-12 years (n=13).


OVER 13 YEARS OF CLINICAL TRIAL SAFETY DATA TO HELP YOU BE READY FOR THE UNEXPECTED

15,137+

previously treated patients

15,137+

exposure daysi

292

patient-years of experiencej

0

inhibitors or blood clots in previously treated patients

Patient Timothy sitting in a chair

  • 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.

  • Your body can also make antibodies called “inhibitors” against Factor 9, including Rebinyn®, which may stop Rebinyn® from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time. Formation of inhibitors to Factor IX has occurred following Rebinyn®.

  • Common side effects in previously untreated patients include FIX inhibitors.

iAn exposure day is defined as a unit of time (1 day) during which a patient receives factor treatment.

j292 patient-years of experience defined as the total number of years all patients have been treated with Rebinyn®.

Two Hemophilia Community Liaisons

WE'RE HERE TO HELP

Wondering about Rebinyn® or living with hemophilia B? Our Hemophilia Community Liaisons (HCLs) are here to answer your questions and connect you with the resources you need.

Two Hemophilia Community Liaisons

WE'RE HERE TO HELP

Wondering about Rebinyn® or living with hemophilia B? Our Hemophilia Community Liaisons (HCLs) are here to answer your questions and connect you with the resources you need.

STAY IN THE KNOW.

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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, 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.