We are sharing this information so you’ll know what to expect from the process of preparing a Rebinyn® dose. For full instructions, refer to the FDA-approved patient information and Instructions for Use.

PERFORMING AN INFUSION

You probably have questions about what it’s like to infuse your factor product. First, there are a few things you should know: 

  • Accidental sticks with a needle can occur. If injury occurs, you should obtain immediate medical attention. Be sure to place needles in a sharps container after single-use
  • Before administration, inspect the reconstituted Rebinyn® solution visually for particulate matter and discoloration, whenever solution and container permit. Do not use if you see particulate matter or discoloration 
  • Do not administer Rebinyn® in the same tubing or container with other medicinal products
Sticky note: Rebinyn® can be infused in 1-4 minutes

ADMINISTRATION, STEP BY STEP

You’ll be administering your factor by intravenous injection, either at a hemophilia treatment center, a health care provider’s office, or at home, after you’ve received training. Here are the steps for infusing on your own:

  1. First, invert the Rebinyn® vial and slowly draw the solution into the syringe.
  2. Next, detach the syringe from the vial adapter by turning the syringe counterclockwise. 
  3. Attach the syringe to the luer end of an infusion needle set. 
  4. Inject the reconstituted Rebinyn® intravenously slowly over 1 to 4 minutes. 
  5. When you’re finished, safely dispose of the syringe with the infusion set, the vial with the vial adapter, any unused Rebinyn®, and other waste materials.

Do not attempt to do an infusion yourself unless you have been taught how by your health care professional or hemophilia treatment center.

For full instructions, refer to the FDA-approved patient information and Instructions for Use.

BE SURE TO TRACK YOUR BLEEDS

It’s important to maintain accurate records of your bleeds and infusions. We’ve created ways to help. Every Rebinyn® vial comes with a peel-off label that you can add to your infusion log, and now you can download your own infusion logbook to make it easy to keep information organized.

For even more convenience, download a free mobile app that helps you track and share details about your treatment.

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.