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-FDA-1088.

How do I store GILENYA?

Store GILENYA in the original blister pack in a dry place.

Store GILENYAat 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.Novartis.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.

Manufactured by:

Novartis Pharma Stein AG

Stein, Switzerland

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

© Novartis

T2011-104/T2010-82
July 2011/September 2010

Package Label – 0.5 mg

Rx OnlyNDC 0078-0607-51

GILENYA™

(fingolimod)

Capsules

28 Capsules

0.5 mg

Equivalent to 0.56 mg fingolimod hydrochloride

This package contains a four-week supply of capsules.

Dispense with enclosed Medication Guide.

GILENYA
fingolimod hcl capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0607
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FINGOLIMOD HYDROCHLORIDE (FINGOLIMOD)  FINGOLIMOD 0.5mg
&