Vaccines: Avoid live attenuated vaccines during, and for 2 months after stopping GILENYA treatment, due to risk of infection. (5.2, 7)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. Pregnancy registry available. (8.1)

Pediatric patients: Safety andeffectiveness havenot been established.(8.4)

Hepatic impairment: Monitor patients with severe hepatic impairment closely, as GILENYA exposure is doubled,and risk of adverse reactions is greater.(5.5, 8.5, 12.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide 

Revised: 07/2011

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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 

1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Bradyarrhythmia and Atrioventricular Blocks
5.2 Infections
5.3 Macular Edema
5.4 Respiratory Effects
5.5Hepatic Effects5.6 Fetal Risk
5.7Blood Pressure Effects
5.8Immune System Effects Following GILENYA Discontinuation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION17.1 Benefits and Risks
17.2 Cardiac Effects
17.3 Risk of Infections
17.4 Macular Edema
17.5 Respiratory Effects
17.6 Hepatic Effects
17.7 Fetal Risk
17.8 Persistence of GILENYA effects after drug discontinuation

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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
GILENYA is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

2 DOSAGE AND ADMINISTRATION
The recommended dose of GILENYA is 0.5 mg orally once daily. Patients should be observed for 6 hours after the first dose to monitor for signs and symptoms of bradycardia [see Warnings and Precautions (5.1)]. Fingolimod doses higher than 0.5 mg are associated with a greater incidence of adverse reactions without additional benefit.

GILENYA can be taken with or without food.

3 DOSAGE FORMS AND STRENGTHS
GILENYA is available as 0.5 mg hard capsules with a white opaque body and bright yellow cap imprinted with “FTY 0.5 mg” on the cap and two radial bands imprinted on the capsule body with yellow ink.

4 CONTRAINDICATIONS
None

5 WARNINGS AND PRECAUTIONS
5.1 Bradyarrhythmia and Atriove