![Rebinyn® (Coagulation Factor IX [Recombinant], GlycoPEGylated)](/content/dam/biopharm/rebinyn/global/rebinyn_logo.png){kind=logo}
Your doctor may adjust your dosing regimen based on your bleeding pattern and physical activity.
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%).
SIMPLE ONCE-WEEKLY DOSING FOR ROUTINE PROPHYLAXIS:
SIMPLE ONCE-WEEKLY DOSING FOR ROUTINE PROPHYLAXIS:
MAINTAINING FACTOR LEVELS BETWEEN DOSES
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
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
Ages 7-12
n=13
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
previously treated patients
exposure daysi
patient-years of experiencej
inhibitors or blood clots in previously treated patients
- 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®.
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.
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.