GILENYA 0.5mg
N=425
%
 Placebo
N=418
%
Infections  
Influenza viral infections 13 10
Herpes viral infections 9 8
Bronchitis 8 4
Sinusitis  7 5
Gastroenteritis 5 3
Tinea infections 4 1
Cardiac Disorders  
Bradycardia 4 1
Nervous system disorders  
Headache 25 23
Dizziness 7 6
Paresthesia 5 4
Migraine 5 1
Gastrointestinal disorders  
Diarrhea 12 7
General disorders and administration site conditions  
Asthenia 3 1
Musculoskeletal and connective tissue disorders  
Back pain 12 7
Skin and subcutaneous tissue disorders  
Alopecia 4 2
Eczema 3 2
Pruritus 3 1
Investigations  
ALT/AST increased 14 5
GGT increased 5 1
Weight decreased 5 3
Blood triglycerides increased 3 1
Respiratory, thoracic and mediastinal disorders  
Cough 10 8
Dyspnea 8 5
Psychiatric disorders  
Depression 8 7
Eye disorders  
Vision blurred 4 1
Eye pain 3 1
Vascular disorders  
Hypertension 6 4
Blood and lymphatic system disorders  
Lymphopenia 4 1
Leukopenia 3 <1

Adverse reactions in Study 2, a 1-year active-controlled (vs. interferon beta-1a, n=431) study including849 patients with MS treated with fingolimod, were generally similar to those in Study 1.

Vascular Events

Vascular events, including ischemic and hemorrhagic strokes, peripheral arterial occlusive disease and posterior reversible encephalopathy syndrome were reported in premarketing clinical trials in patients who receivedGILENYAdoses (1.25-5 mg) higher than recommended for use in MS. No vascular events were observed with GILENYA 0.5 mg in the premarketing database.

Lymphomas

Cases of lymphoma (cutaneous T-cell lymphoproliferative disorders or diffuse B-cell lymphoma) were reported in premarketing clinical trials in MS patients receiving GILENYA at, or above, the recommended dose of 0.5 mg. Based on the small number of cases and short duration of exposure, the relationship to GILENYA remains uncertain.

7 DRUG INTERACTIONS
Class Ia or Class III antiarrhythmic drugs

GILENYA has not been studied in patients with arrhythmias requiring treatment with Class Ia (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol)antiarrhythmic drugs. Class Ia and Class III antiarrhythmic drugs have been associated with cases of torsades de pointes in patients with bradycardia. Since initiation of GILENYA treatment results in decreased heart rate, patients on Class Ia or Class III antiarrhythmic drugs should be closely monitored [see Warnings and Precautions (5.1)].

Ketoconazole

The blood levels of fingolimod and fingolimod-phosphate are increased by 1.7-fold when coadministered with ketoconazole. Patients who use GILENYAand systemic ketoconazole concomitantly should be closely monitored, as the risk of adverse reactions is greater.

Vaccines

Vaccination may be less effective during and for up to 2 months after discontinuation of treatment with GILENYA [see Clinical Pharmacology (12.2)]. The use of live attenuated vaccines should be avoided during and for 2