| 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 (Cont’d) |
| 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. |
