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IMPORTANT SAFETY INFORMATION
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LEMTRADA can
cause serious side effects including:
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Serious
autoimmune problems: Some people
receiving LEMTRADA develop a condition where the immune cells in your
body attack other cells or organs in the body (autoimmunity), which can
be serious and may cause death. Serious autoimmune problems may
include:
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Immune
thrombocytopenia, which is when reduced platelet counts in your blood
cause severe bleeding that, if not treated, may cause
life-threatening problems. Call your healthcare provider right away
if you have any of the following symptoms: easy bruising; bleeding
from a cut that is hard to stop; heavier menstrual periods than
normal; bleeding from your gums or nose that is new or takes longer
than usual to stop; small, scattered spots on your skin that are red,
pink, or purple
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Kidney
problems called anti-glomerular basement membrane disease, which can,
if untreated, lead to severe kidney damage, kidney failure that needs
dialysis, a kidney transplant, or death. Call your healthcare
provider right away if you have any of the following symptoms: blood
in the urine (red or tea-colored urine); swelling of legs or feet;
coughing up blood
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It is important
for you to have blood and urine tests before you receive, while you are
receiving and every month, for 4 years or longer, after you receive
your last LEMTRADA infusion.
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Serious
infusion reactions: LEMTRADA can
cause serious infusion reactions that may cause death. Serious infusion
reactions may happen while you receive, or up to 24 hours or longer
after you receive LEMTRADA.
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You will
receive your infusion at a healthcare facility with equipment and
staff trained to manage infusion reactions, including serious
allergic reactions, and urgent heart or breathing problems. You will
be watched while you receive, and for 2 hours or longer after you
receive, LEMTRADA. If a serious infusion reaction happens while you
are receiving LEMTRADA, your infusion may be stopped.
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Tell your
healthcare provider right away if you have any of the following
symptoms of a serious infusion reaction during the infusion, and after
you have left the healthcare facility:
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swelling
in your mouth or throat
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trouble
breathing
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weakness
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fast,
slow, or irregular heartbeat
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chest pain
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rash
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To lower your
chances of getting a serious infusion reaction, your healthcare
provider will give you a medicine called corticosteroids before your
first 3 infusions of a treatment course. You may also be given other
medicines before or after the infusion to try to reduce your chances of
having these reactions or to treat them after they happen.
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Certain
cancers:
Receiving LEMTRADA may increase your
chance of getting some kinds of cancers, including thyroid cancer, skin
cancer (melanoma), and blood cancers called lymphoproliferative
disorders and lymphoma. Call your healthcare provider if you have the
following symptoms that may be a sign of thyroid cancer:
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new lump
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swelling
in your neck
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pain in
front of neck
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hoarseness
or other voice changes that do not go away
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trouble
swallowing or breathing
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cough that
is not caused by a cold
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Have your skin
checked before you start receiving LEMTRADA and each year while you are
receiving treatment to monitor for symptoms of skin cancer.
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Because of risks
of autoimmunity, infusion reactions, and some kinds of cancers,
LEMTRADA is only available through a restricted program called the
LEMTRADA Risk Evaluation and Mitigation Strategy (REMS) Program.
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Thyroid
problems:
Some patients taking LEMTRADA may get an
overactive thyroid (hyperthyroidism) or an underactive thyroid
(hypothyroidism). Call your healthcare provider if you have any of
these symptoms:
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excessive
sweating
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unexplained
weight loss
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eye
swelling
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nervousness
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fast
heartbeat
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unexplained
weight gain
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feeling
cold
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worsening
tiredness
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constipation
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Low blood
counts (cytopenias): LEMTRADA may
cause a decrease in some types of blood cells. Some people with these
low blood counts have increased infections. Call your doctor right away
if you have symptoms of cytopenias such as:
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weakness
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chest pain
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yellowing
of the skin or whites of the eyes (jaundice)
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dark urine
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fast
heartbeat
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Serious
infections:
LEMTRADA may cause you to have a serious
infection while you receive and after receiving a course of treatment.
Serious infections may include:
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Herpes viral
infections.
Some people taking LEMTRADA have an
increased chance of getting herpes viral infections. Take any
medicines as prescribed by your healthcare provider to reduce your
chances of getting these infections.
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Tuberculosis. Your healthcare provider should check you for
tuberculosis before you receive LEMTRADA.
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Hepatitis. People who are at high risk of, or are carriers of,
hepatitis B (HBV) or hepatitis C (HCV) may be at risk of irreversible
liver damage.
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These are not
all the possible infections that could happen while on LEMTRADA. Call
your healthcare provider right away if you have symptoms of a serious
infection such as fever or swollen glands. Talk to your healthcare
provider before you get vaccinations after receiving LEMTRADA. Certain
vaccinations may increase your chances of getting infections.
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Swelling of
lung tissue (pneumonitis): Some people have
had swelling of the lung tissue while receiving LEMTRADA. Call your
healthcare provider right away if you have the following symptoms:
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shortness
of breath
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cough
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wheezing
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chest pain
or tightness
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coughing
up blood
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Before
receiving LEMTRADA, tell your healthcare provider if you:
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are taking a
medicine called Campath® (alemtuzumab)
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have bleeding,
thyroid, or kidney problems
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have HIV
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have a recent
history of infection
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have received
a live vaccine in the past 6 weeks before receiving LEMTRADA or plan
to receive any live vaccines. Ask your healthcare provider if you are
not sure if your vaccine is a live vaccine
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are pregnant
or plan to become pregnant. LEMTRADA may harm your unborn baby. You
should use birth control while receiving LEMTRADA and for 4 months
after your course of treatment
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are
breastfeeding or plan to breastfeed. You and your healthcare provider
should decide if you should receive LEMTRADA or breastfeed. You
should not do both.
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Tell your
healthcare provider about all the medicines you take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. LEMTRADA and other medicines may
affect each other, causing side effects. Especially tell your
healthcare provider if you take medicines that increase your chance of
getting infections, including medicines used to treat cancer or to
control your immune system.
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The most
common side effects of LEMTRADA include:
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rash
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headache
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thyroid
problems
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fever
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swelling
of your nose and throat
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nausea
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urinary
tract infection
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feeling
tired
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trouble
sleeping
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upper
respiratory infection
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herpes
viral infection
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hives
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itching
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fungal
infection
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joint pain
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pain in
your arms
or legs
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back pain
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diarrhea
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sinus
infection
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mouth pain
or sore throat
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tingling
sensation
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dizziness
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stomach
pain
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sudden
redness in face, neck, or chest
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vomiting
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Tell your
healthcare provider if you have any side effect that bothers you or
that does not go away. These are not all the possible side effects of
LEMTRADA.
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You are
encouraged to report side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch
or call 1-800-FDA- 1088.
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Copyright ©2015
Genzyme Corporation, a Sanofi company. All rights reserved. LEMTRADA
and Genzyme are registered trademarks of Genzyme Corporation.
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Genzyme
Corporation
500 Kendall St.
Cambridge, MA 02142
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Intended for
US residents only.
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GZUS.LEMT.15.07.1936
Last Update: July 2015
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