Read this Medication Guide before you start using AUBAGIO and
each time you get a refill. There may be new information. This
information does not take the place of talking with your doctor about
your medical condition or your treatment.
What is the most important information I should know about
AUBAGIO may cause serious side effects, including:
• Liver problems: AUBAGIO may cause serious liver problems
that may lead to death. Your risk of liver problems may be
higher if you take other medicines that also affect your liver.
Your doctor should do blood tests to check your liver:
„ within 6 months before you start taking AUBAGIO
„ 1 time a month for 6 months after you start taking AUBAGIO
Call your doctor right away if you have any of the following
symptoms of liver problems:
„ stomach pain
„ loss of appetite
„ your skin or the whites of your eyes turn yellow
„ dark urine
• Harm to your unborn baby: AUBAGIO may cause harm to
your unborn baby. Do not take AUBAGIO if you are pregnant.
Do not take AUBAGIO unless you are using effective birth
„ If you are a female, you should have a pregnancy test
before you start taking AUBAGIO. Use effective birth control
during your treatment with AUBAGIO.
„ After stopping AUBAGIO, continue using effective birth
control until you have blood tests to make sure your blood
levels of AUBAGIO are low enough. If you become pregnant while taking AUBAGIO or within 2 years after you stop
taking it, tell your doctor right away.
„ AUBAGIO Pregnancy Registry. If you become pregnant
while taking AUBAGIO or during the 2 years after you stop
taking AUBAGIO, talk to your doctor about enrolling in the
AUBAGIO Pregnancy Registry at 1-800-745-4447, option
2. The purpose of this registry is to collect information about
your health and your baby’s health.
„ For men taking AUBAGIO:
Á If your female partner plans to become pregnant, you
should stop taking AUBAGIO and ask your doctor how to
quickly lower the levels of AUBAGIO in your blood.
Á If your female partner does not plan to become pregnant,
you and your female partner should use effective birth
control during your treatment with AUBAGIO. AUBAGIO
remains in your blood after you stop taking it, so continue
using effective birth control until AUBAGIO blood levels
have been checked and they are low enough.
AUBAGIO may stay in your blood for up to 2 years after you
stop taking it. Your doctor can prescribe a medicine to help
lower your blood levels of AUBAGIO more quickly. Talk to your
doctor if you want more information about this.
What is AUBAGIO?
AUBAGIO is a prescription medicine used to treat relapsing forms
of multiple sclerosis (MS). AUBAGIO can decrease the number of
MS flare-ups (relapses). AUBAGIO does not cure MS, but it can
help slow down the physical problems that MS causes.
It is not known if AUBAGIO is safe and effective in children.
Who should not take AUBAGIO?
Do not take AUBAGIO if you:
• have severe liver problems
• are pregnant or are of childbearing age and not using effective
• take a medicine called leflunomide
What should I tell my doctor before taking AUBAGIO?
Before you take AUBAGIO, tell your doctor if you:
• have liver or kidney problems
• have a fever or infection, or you are unable to fight infections
• have numbness or tingling in your hands or feet that is different
from your MS symptoms
• have diabetes
• have had serious skin problems when taking other medicines
• have breathing problems
• have high blood pressure
• are breastfeeding or plan to breastfeed. It is not known if
AUBAGIO passes into your breast milk. You and your doctor
should decide if you will take AUBAGIO or breastfeed. You
should not do both at the same time.
Tell your doctor about all the medicines you take, including
prescription and non-prescription medicines, vitamins, and herbal
Using AUBAGIO and other medicines may affect each other
causing serious side effects. AUBAGIO may affect the way other
medicines work, and other medicines may affect how AUBAGIO
Especially tell your doctor if you take medicines that could raise
your chance of getting infections, including medicines used to treat
cancer or to control your immune system.
Ask your doctor or pharmacist for a list of these medicines if you
are not sure.
Know the medicines you take. Keep a list of them to show your
doctor or pharmacist when you get a new medicine.
How should I take AUBAGIO?
• Take AUBAGIO exactly as your doctor tells you to take it.
• Take AUBAGIO 1 time each day.
• Take AUBAGIO with or without food.
What are possible side effects of AUBAGIO?
AUBAGIO may cause serious side effects, including:
• See ;What is the most important information I should know
• decreases in your white blood cell count. Your white blood
cell counts should be checked before you start taking
AUBAGIO. When you have a low white blood cell count you:
„ may have more frequent infections. You should have a
skin test for TB (Tuberculosis) before you start taking
AUBAGIO. Tell your doctor if you have any of these
symptoms of an infection:
• body aches
„ should not receive certain vaccinations during your
treatment with AUBAGIO and for 6 months after your
treatment with AUBAGIO ends.
• numbness or tingling in your hands or feet that is different
from your MS symptoms. You have a greater chance of
getting peripheral neuropathy if you:
„ are over 60 years of age
„ take certain medicines that affect your nervous system
„ have diabetes
Tell your doctor if you have numbness or tingling in your hands
or feet that is different from your MS.
• kidney problems. Tell your doctor if you have pain in your side
• high potassium levels in your blood. Tell your doctor if you
have nausea that does not go away or a racing heartbeat.