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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®?
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Do not use Rebinyn®
if you:
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are allergic to Factor IX or any of the other
ingredients of Rebinyn®.
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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.
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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®.
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|
|
Who should not use Rebinyn®?
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Do not use Rebinyn®
if you:
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|
•
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are allergic to Factor IX or any of the other
ingredients of Rebinyn®.
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|
•
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are allergic to hamster proteins.
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What should I tell my healthcare provider before using
Rebinyn®?
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Tell your healthcare provider if you:
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have or have had any medical conditions.
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take any medicines, including non-prescription
medicines and dietary supplements.
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are nursing, pregnant, or plan to become
pregnant.
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have been told you have inhibitors to Factor IX.
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How should I use Rebinyn®?
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Rebinyn®
is given as an infusion into the vein.
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Call your healthcare provider right away if
your bleeding does not stop after taking
Rebinyn®.
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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.
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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.
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Tell your healthcare provider about any
side effect that bothers you or that does
not go away.
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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.
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