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IS REBINYN® RIGHT FOR YOU?

It’s important to consider all your options when choosing a Factor 9 treatment. See different Factor 9 therapies; Rebinyn® may be the one for you.

It’s important to consider all your options when choosing a Factor 9 treatment. See how Rebinyn® compares to others—it may be the one for you.

Emili and son with hemophilia b

All images of hemophilia B patients shown are for illustrative purposes only.

> Choosing Therapies

IS REBINYN® RIGHT
FOR YOU?

It’s important to consider all your options when choosing a Factor 9 treatment. See different Factor 9 therapies; Rebinyn® may be the one for you.

Emili and son with hemophilia b
Graph showing Rebinyn delivered higher factor 9 levels longer than Benefix
Graphic showing Rebinyn with 93 hour half-life

pdFIX=plasma-derived Factor 9; rFIX=recombinant Factor 9; SHL=standard half-life.

aPhase 1 trial comparing pharmacokinetics 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 pharmacokinetic 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 PK differences is unknown.

IN A RETROSPECTIVE, OBSERVATIONAL, REAL-WORLD STUDY OF 42 PATIENTS,b FEWER BLEEDS WERE SEEN IN PATIENTS WHO SWITCHED TO REBINYN®

IN A RETROSPECTIVE, OBSERVATIONAL, REAL-WORLD STUDY OF 42 PATIENTS,b FEWER BLEEDS WERE SEEN IN PATIENTS WHO SWITCHED TO REBINYN®

Total mean ABR when switching, chart
Alprolix graph

ABR=annualized bleeding rate.

bBased on a retrospective, observational, real-world study of 42 patients with hemophilia B (5 patients were less than 18 years old) who switched from either BeneFIX® or Alprolix® prophylaxis to Rebinyn® prophylaxis using published Canadian Bleeding Disorders Registry (CBDR) data. Patients had to be on a previous therapy for at least 6 months and have at least 6 months of follow-up with Rebinyn®. CBDR formulary required a switch from Alprolix® to Rebinyn®, and patients had the option to switch from BeneFIX® to Rebinyn®. The study took place in part during the COVID-19 pandemic which limited attendance at hemophilia clinics for physical examinations. Total mean ABR is based on intrapatient bleeding, which is the bleeding rate in each patient before and after switching from BeneFIX® or Alprolix® prophylaxis to Rebinyn® prophylaxis.

REBINYN® DELIVERED HIGHER FACTOR 9 LEVELS LONGER THAN ALPROLIX®f

REBINYN® DELIVERED HIGHER FACTOR 9 LEVELS LONGER THAN ALPROLIX®f

Rebinyn and Alprolix graph
rebinyn factor coverage vs alprolix chart

fPhase 1 trial comparing pharmacokinetics of Rebinyn® with Alprolix®. Based upon a phase 1 study of 15 patients administered a single dose of Rebinyn® 50 IU/kg compared with a single dose of Alprolix® 50 IU/kg using both 1-stage (shown above) and chromogenic assays. The standard Alprolix® dose of 50 IU/kg was administered for both products to allow for comparison of dose-dependent parameters; dose normalized to 50 IU/kg to reflect minor differences in dose administered. Geometric mean half-life was also prolonged (Rebinyn®: 103.2 hours, Alprolix®: 84.9 hours). All comparisons were significant (P<0.0001) for all assays. The clinical relevance of these pharmacokinetic differences is unknown.

IN A RETROSPECTIVE, OBSERVATIONAL, REAL-WORLD STUDY OF 42 PATIENTS,g FEWER BLEEDS WERE SEEN IN PATIENTS WHO SWITCHED TO REBINYN®

IN A RETROSPECTIVE, OBSERVATIONAL, REAL-WORLD STUDY OF 42 PATIENTS,g FEWER BLEEDS WERE SEEN IN PATIENTS WHO SWITCHED TO REBINYN®

less rebinyn if multiple previous shl doses
Alprolix graph

 

ABR=annualized bleeding rate.

gBased on a retrospective, observational, real-world study of 42 patients with hemophilia B (5 patients were less than 18 years old) who switched from either BeneFIX® or Alprolix® prophylaxis to Rebinyn® prophylaxis using published Canadian Bleeding Disorders Registry (CBDR) data. Patients had to be on a previous therapy for at least 6 months and have at least 6 months of follow-up with Rebinyn®. CBDR formulary required a switch from Alprolix® to Rebinyn®, and patients had the option to switch from BeneFIX® to Rebinyn®. The study took place in part during the COVID-19 pandemic which limited attendance at hemophilia clinics for physical examinations. Total mean ABR is based on intrapatient bleeding, which is the bleeding rate in each patient before and after switching from BeneFIX® or Alprolix® prophylaxis to Rebinyn® prophylaxis.

FOR ON-DEMAND TREATMENT, REBINYN® MAY REDUCE THE NEED FOR ADDITIONAL INFUSIONS VS EXTENDED HALF-LIFE ALPROLIX®h,i

FOR ON-DEMAND TREATMENT, REBINYN® MAY REDUCE THE NEED FOR ADDITIONAL INFUSIONS VS EXTENDED HALF-LIFE ALPROLIX®h,i

Estimated number of doses and amount of Factor 9 per episode, based on pharmacokinetic (PK) modeling (a mathematical simulation)

Estimated doses and amount of Factor 9 per episode, chart

 

hA single dose of Rebinyn® 40 IU/kg should be enough for minor and moderate bleeds. Your doctor may recommend additional doses of 40 IU/kg.

iBased on pharmacokinetic modeling to WFH guidelines. Simulated results based on phase 1 pharmacokinetic studies of Rebinyn® (n=15) and Alprolix® (n=15).

HERE’S HOW REBINYN® COMPARES WITH OTHER FIX PRODUCTS BASED ON SELECTED KEY ATTRIBUTES

HERE’S HOW REBINYN® COMPARES WITH OTHER FIX PRODUCTS BASED ON SELECTED KEY ATTRIBUTES

how rebinyn compares chart

 

hAdjust dosing regimen based on individual response

PI=Prescribing Information


Data from Rebinyn® PI, 2022; Alprolix® PI, 2023; Idelvion® PI, 2023; BeneFIX® PI, 2021; Ixinity® PI, 2024; and Rixubis® PI, 2025.

Not intended to be a comparison of efficacy and safety.

PREVENT BLEEDS WITH REBINYN®

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

dosing storage simple as 1 2 3

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WE'RE HERE TO HELP

Connect with a Rare Blood Community Liaison (RBCL) for hemophilia-related resources.
 

Two Rebinyn HCLs

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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 Rebinyn® 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.