| Selected Important Safety Information |
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What is the most important information I need to know about Rebinyn®?
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| • |
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®.
|
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| 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. |
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| Indications and Usage |
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What is Rebinyn® Coagulation Factor IX (Recombinant), GlycoPEGylated?
|
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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.
|
|
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What are the possible side effects of Rebinyn®?
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| • |
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.
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Please click here for
Prescribing Information.
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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.
|
