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IMPORTANT SAFETY
INFORMATION
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Do not take
AUBAGIO:
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• If you have severe liver
problems. AUBAGIO may cause serious liver problems, which can be life-threatening.
Your risk may be higher if you take other medicines
that affect your liver. Your healthcare provider should do blood tests
to check your liver within 6 months before you start AUBAGIO and
monthly for 6 months after starting AUBAGIO. Tell your healthcare
provider right away if you develop any of these symptoms of liver
problems: nausea, vomiting, stomach pain, loss of appetite, tiredness,
yellowing of your skin or whites of your eyes, or dark urine.
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• If you take a medicine
called leflunomide.
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• If you are pregnant or are
of childbearing potential and not using effective birth control. AUBAGIO
may harm an unborn baby. You should have a pregnancy
test before starting AUBAGIO. After stopping AUBAGIO, continue to use
effective birth control until you have made sure your blood levels of
AUBAGIO are lowered. If you become pregnant while taking AUBAGIO or
within 2 years after stopping, tell your healthcare provider right away
and enroll in the AUBAGIO Pregnancy Registry at 1-800-745- 4447, option
2.
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It is not known
if AUBAGIO passes into breast milk. Your healthcare provider can help you
decide if you should take AUBAGIO or breastfeed – you should not do both
at the same time.
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If you are a man
whose partner plans to become pregnant, you should stop taking AUBAGIO and talk
with your healthcare provider about reducing the levels of AUBAGIO in
your blood. If your partner does not plan to become pregnant, use
effective birth control while taking AUBAGIO.
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AUBAGIO may stay
in your blood for up to 2 years after you stop taking it. Your healthcare provider can prescribe
a medicine that can remove AUBAGIO from your body quickly.
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Before taking
AUBAGIO, talk with your healthcare provider if you have: liver or kidney problems; a fever or
infection, or if you are unable to fight infections; numbness or tingling
in your hands or feet that is different from your MS symptoms; diabetes;
serious skin problems when taking other medicines; breathing problems; or
high blood pressure. Your healthcare provider will check your white blood
cell count and TB test before you start AUBAGIO. Talk with your
healthcare provider if you take or are planning to take other medicines
(especially medicines for treating cancer or controlling your immune
system), vaccines, vitamins or herbal supplements.
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AUBAGIO may
cause serious side effects, including: reduced white blood cell count – this
may cause you to have more infections; numbness or tingling in your hands
or feet that is different from your MS symptoms; kidney problems; high
potassium levels in your blood; serious skin problems; breathing problems
(new or worsening); and high blood pressure.
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The most common
side effects when taking AUBAGIO include: abnormal liver test results; hair
thinning or loss; diarrhea; flu; upset stomach; and burning or prickling
feeling in your skin. These are not all the side effects of AUBAGIO. Tell
your healthcare provider about any side effect that bothers you.
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Consult your
healthcare provider if you have questions about your health or any
medications you may be taking, including AUBAGIO.
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You are
encouraged to report side effects of prescription drugs to the FDA.
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