> Safety Considerations

DESIGNED FOR SAFETY

The safety of Rebinyn® has been established in 5 clinical trials over 13 years.

OVER 13 YEARS OF CLINICAL TRIAL SAFETY DATA

115

previously treated patients

15,137+

exposure days in previously treated patientsa

292

patient-years of experience in previously treated patientsb

0

inhibitors or blood clots in previously treated patients

Patient Timothy sitting in a chair

Timothy has severe hemophilia B
and uses Rebinyn®.

  • 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 9 has occurred following Rebinyn®.

  • Common side effects in previously untreated patients include Factor 9 inhibitors.

aAn exposure day is defined as a unit of time (1 day) during which a patient receives factor treatment.

b292 patient-years of experience defined as the total number of years all patients have been treated with Rebinyn®.

MANUFACTURED WITH SAFETY IN MIND

Rebinyn® is a Factor 9 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.

MANUFACTURED WITH SAFETY IN MIND

Rebinyn® is a Factor 9 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?

  • 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 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.

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 9 or any of the other ingredients in Rebinyn®, or if you are allergic to hamster proteins. If you are not sure, talk to your healthcare provider about what this may mean for you. 

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.

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

For more information, talk to your healthcare provider.

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.

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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 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.