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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.

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.

HERE’S HOW REBINYN® COMPARES WITH STANDARD HALF-LIFE (SHL) FACTOR IX

HERE’S HOW REBINYN® COMPARES WITH STANDARD HALF-LIFE (SHL) FACTOR IX

May reduce the need for additional infusionsa-c

May reduce the need for additional infusionsa-c

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

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

bBased 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).

cCompared with SHL products.

Reduces the amount of FIX needed

Reduces the amount of FIX needed

In a phase 3 study in previously treated adolescents and adults.

  • Half of the patients treated on-demand were able to resolve all bleeds with a single dose of Rebinyn®
  • Of the remaining patients, those previously treated with multiple high dosesa saw a meaningful decrease in FIX use with Rebinyn®

Patients previously treating with multiple SHL doses needed up to 80% less FIXd with Rebinyn®

dIn a phase 3 study, the efficacy of Rebinyn® in adults/adolescents was evaluated. The on-demand arm included 15 patients; one 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-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

HERE’S HOW REBINYN® COMPARES WITH OTHER FIX PRODUCTS

HERE’S HOW REBINYN® COMPARES WITH OTHER FIX PRODUCTS


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.

HOW IT EXTENDS HALF-LIFE

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

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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 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.