• Medicines that could raise your chance of getting infections,
such as medicines to treat cancer or to control your immune
system.
• ketoconazole (an antifungal drug) by mouth
Ask your doctor or pharmacist for a list of these medicines if you
are not sure.
How should I take GILENYA?
• Your first dose of GILENYA will be given in a doctor’s office
or clinic, where you will be observed for 6 hours after your
first dose of GILENYA.
• Take GILENYA exactly as your doctor tells you to take it.
• Take GILENYA 1 time each day.
• Take GILENYA with or without food.
• Do not stop taking GILENYA without talking with your doctor
first.
• If you start GILENYA again after stopping for 2 weeks or
more, you will start taking GILENYA again in your doctor’s
office or clinic.
What are possible side effects of GILENYA?
GILENYA can cause serious side effects.
See “What is the most important information I should know
about GILENYA?”
Serious side effects include:
• Breathing Problems. Some people who take GILENYA have
shortness of breath. Call your doctor right away if you have
trouble breathing.
• Liver problems. GILENYA may cause liver problems. Your
doctor should do blood tests to check your liver before you
start taking GILENYA. Call your doctor right away if you have
any of the following symptoms of liver problems:
• nausea
• vomiting
• stomach pain
• loss of appetite
• tiredness
• your skin or the whites of your eyes turn yellow
• dark urine
The most common side effects of GILENYA include:
• headache
• flu
• diarrhea
• back pain
• abnormal liver tests
• cough
Tell your doctor if you have any side effect that bothers you or
that does not go away.
These are not all of the possible side effects of GILENYA. For
more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-332-1088.
How do I store GILENYA?
• Store GILENYA in the original blister pack in a dry place.
• Store GILENYA at room temperature between 59°F to 86°F
( 15°C to 30°C).
• Keep GILENYA and all medicines out of the reach of children.
General information about GILENYA
Medicines are sometimes prescribed for purposes other than
those listed in a Medication Guide. Do not use GILENYA for a
condition for which it was not prescribed. Do not give GILENYA
to other people, even if they have the same symptoms you have.
It may harm them.
This Medication Guide summarizes the most important information about GILENYA. If you would like more information, talk with
your doctor. You can ask your doctor or pharmacist for information about GILENYA that is written for healthcare professionals.
For more information, go to www.pharma.US.No
vartis.com or
call 1-888-669-6682.
What are the ingredients in GILENYA?
Active ingredient: fingolimod
Inactive ingredients: gelatin, magnesium stearate, mannitol, titanium dioxide, yellow iron oxide.
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
GILENYA is a trademark of Novartis AG.
Issued September 2010
Printed in the USA
T2010-82
5002679
Manufactured by:
Novartis Pharma Stein AG
Stein, Switzerland
Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
©Novartis
