> Safety Considerations

DESIGNED FOR SAFETY

The safety of Rebinyn® has been clinically studied over 8801 exposure days, and it is manufactured to

minimize risk.

Clayton hemophilia b selfie

Images is for illustrative purposes only.

Image is for illustrative purposes only.

ESTABLISHED SAFETY PROFILE

In clinical studies, Rebinyn® was shown to be safe and effective, with 0 inhibitors and blood clots.

rebinyn 0 inhibitors, rebinyn 115 tested patients inhibitors

MANUFACTURED WITH SAFETY IN MIND

Rebinyn® is a Factor IX recombinant therapy, which means it is made without any human-derived components, such as blood, plasma, or proteins.

The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC), which provides guidance on treatment for the bleeding disorders community, recommends recombinant products as a first-line therapy for previously treated patients with hemophilia B.

WHAT ABOUT SIDE EFFECTS?

  • The most frequently reported side effects included allergic reaction to medication (1%), itching (3%), and injection site reactions (4%)a 
  • Your body may make antibodies called inhibitors against Factor IX (Rebinyn®), which may stop Rebinyn® from working properly. Your doctor may test your blood for inhibitors. You may be at an increased risk of forming blood clots 

aIn previously treated patients with moderate to severe hemophilia (≤2% factor levels), including 40 treated for 2 or more years.

WHO SHOULD NOT TAKE REBINYN®?

It’s important to note that Rebinyn® is not for everyone. You should not use Rebinyn® if you are allergic to factor IX or any of the other ingredients in Rebinyn®, or if you are allergic to hamster proteins. If you are not sure, talk to your health care provider about what this may mean for you. 

See the complete list of side effects and contraindications in the Prescribing Information.

For more information, talk to your health care provider.

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.

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We'll show you step-by-step how to start treating with Rebinyn®.

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HOW IT EXTENDS HALF-LIFE

Rebinyn® uses technology that helps it stay in your body longer.

rebinyn extended half life

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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.