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IS REBINYN® RIGHT FOR YOU?

It’s important to consider all your options when choosing a FIX treatment. See how Rebinyn® measures up compared to others—it may be the one for you.

It’s important to consider all your options when choosing a FIX treatment. See how Rebinyn® measures up compared 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.

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IS REBINYN® RIGHT FOR YOU?

It’s important to consider all your options when choosing a FIX treatment. See how Rebinyn® measures up compared to others—it may be the one for you.

HIGHER FACTOR LEVELS FOR LONGER COMPARED TO BENEFIXa

HIGHER FACTOR LEVELS FOR LONGER COMPARED TO BENEFIXa

In a study comparing Rebinyn® (extended half-life FIX) with BeneFIX, Rebinyn® achieved and maintained higher factor levels. Rebinyn® achieved a 93-hour half-life compared to the 19-hour half-life of BeneFIX.a

rebinyn estimated factor levels
rebinyn half-life vs benefix

In the same study, Rebinyn® achieved 2x the recovery rate compared to BeneFIX.

rebinyn recovery rate vs benefix

aBased upon a phase 1 study comparing 25, 50, and 100 IU/kg doses of Rebinyn® to a 50 IU/kg 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 FIX activity is adjusted to a dose of 50 IU/kg.

  • The clinical relevance of these PK differences is unknown
  • Rebinyn® is not used for routine prophylaxis or for immune tolerance therapy
  • Animals given repeat doses of Rebinyn® showed Polyethylene Glycol (PEG) inside cells lining blood vessels in the choroid plexus, which makes the fluid that cushions the brain. The potential human implications of these animal tests are unknown

PATIENTS PREVIOUSLY TREATED WITH MULTIPLE STANDARD HALF-LIFE (SHL) DOSES NEEDED UP TO 80% LESS FIX WITH REBINYN®b

PATIENTS PREVIOUSLY TREATED WITH MULTIPLE STANDARD HALF-LIFE (SHL) DOSES NEEDED UP TO 80% LESS FIX WITH REBINYN®b

less rebinyn if multiple previous shl doses

bIn a phase 3 study, the efficacy of Rebinyn® in adults/adolescents was evaluated. The on-demand arm included 15 patients; 1 patient had no bleeds, the other 14 patients received Rebinyn® 40 IU/kg as single dose for the treatment of bleeds. Patients received on-demand treatment for 28 weeks. 7 patients controlled all bleeds (62 bleeds) with a single 40 IU/kg dose of Rebinyn®. The remaining 7 patients (81 bleeds) required ≥2 doses to control at least one of their bleeds. Of those 7, 4 patients who were previously treated with multiple high-doses (2-3 doses of 60 IU/kg or 80 IU/kg) were able to control 71% of their bleeds with a single dose and used 58%-80% less FIX while using Rebinyn® 40 IU/kg
c243 IU/kg with pdFIX vs 47.5 IU/kg with Rebinyn®. This was reported in one patient. 

REBINYN® MAY REDUCE THE NEED FOR ADDITIONAL INFUSIONS VS SHL BENEFIXd-f

REBINYN® MAY REDUCE THE NEED FOR ADDITIONAL INFUSIONS VS SHL BENEFIXd-f

Compared with recombinant FIX (rFIX) and plasma-derived FIX (pdFIX), Rebinyn® may require fewer infusions per episode for mild to moderate bleeds, severe bleeds, and during and after surgery.

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

rebinyn dose and factor 9 per episode
rebinyn dose and factor 9 per episode

dA single dose should be enough for minor and moderate bleeds. Your doctor may recommend additional doses of 40 IU/kg.
eBased on a pharmacokinetic (PK) modeling to World Federation of Hemophilia (WFH) guidelines. Simulated results based on phase 1 PK study of Rebinyn® (n=15), recombinant FIX (rFIX) (n=7), and plasma-derived FIX (pdFIX) (n=8).
fCompared with SHL products.

HIGHER FACTOR LEVELS FOR LONGER COMPARED TO ALPROLIX®a

HIGHER FACTOR LEVELS FOR LONGER COMPARED TO ALPROLIX®a

When compared to Alprolix in a study, Rebinyn® achieved 4x greater factor coverage. Rebinyn® achieved 96.6 IU x h/mL while Alprolix achieved 22 IU x h/mL.a

rebinyn factor coverage vs alprolix

aBased upon a phase 1 trial of 15 patients who were given a single dose of Rebinyn® 50 IU/kg compared with a single dose of Alprolix 50 IU/kg using tests to measure factor activity level (1-stage and chromogenic assays). The standard Alprolix dose of 50 IU/kg was given for both products to allow for a comparison of dose-dependent measures; a dose standardized or normalized to 50 IU/kg was used to reflect minor differences in the dose given. The average (geometric mean) half-life was also prolonged (Rebinyn®: 103.2 hours, Alprolix: 84.9 hours). It was determined that the results of the measures were unlikely to be attributed to chance (significance P<0.001).

In the same study, Rebinyn® achieved 6x higher factor levels at 7 days vs Alprolix.

rebinyn factor levels 7 days vs alprolix graph

The half-life of Rebinyn® was 103 hours vs 85 hours for Alprolix.

  • The clinical relevance of these PK differences is unknown
  • Rebinyn® is not used for routine prophylaxis or for immune tolerance therapy

BASED ON PHARMACOKINETIC (PK) MODELING, REBINYN® MAY REDUCE THE NEED FOR ADDITIONAL INFUSIONS VS EXTENDED HALF-LIFE ALPROLIX®b,c

BASED ON PHARMACOKINETIC (PK) MODELING, REBINYN® MAY REDUCE THE NEED FOR ADDITIONAL INFUSIONS VS EXTENDED HALF-LIFE ALPROLIX®b,c

rebinyn additional infusions vs alprolix

bA single dose should be enough for minor and moderate bleeds. Your doctor may recommend additional doses of 40 IU/kg. 
cBased on PK modeling to WFH guidelines. Simulated results based on phase 1 PK studies of Rebinyn® (n=15) and Alprolix (n=15).

HERE’S HOW REBINYN® COMPARES WITH OTHER FIX PRODUCTS

HERE’S HOW REBINYN® COMPARES WITH OTHER FIX PRODUCTS

how rebinyn compares chart
how rebinyn compares chart


As of June 2018, Rebinyn®, BeneFIX, and Ixinity are not approved for routine prophylaxis.
Data from Rebinyn® PI, 2017; Alprolix PI, 2018; Idelvion PI, 2018; BeneFIX PI, 2018; Ixinity PI, 2018; and Rixubis PI, 2018.

The above table does not imply that one FIX product is more effective than another product.

KEEP IT SIMPLE

Rebinyn® offers simplified dosing and flexible storage.

dosing storage simple as 1 2 3

HOW IT EXTENDS HALF-LIFE

Rebinyn® uses technology that helps it stay in your body longer, to protect you longer.

rebinyn extended half life

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 and control bleeding in people with hemophilia B. Your healthcare provider may give you Rebinyn® when you have surgery. Rebinyn® is not used for routine prophylaxis or 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 swelling, pain, rash or redness at the location of the infusion, and itching.
  • Call your healthcare provider right away or get emergency treatment right away if you get any of the following signs of an allergic reaction: hives, chest tightness, wheezing, difficulty breathing, and/or swelling of the face.
  • Tell your healthcare provider about any side effect that bothers you or that does not go away.
  • Animals given repeat doses of Rebinyn® showed Polyethylene Glycol (PEG) inside cells lining blood vessels in the choroid plexus, which makes the fluid that cushions 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.