Based on animal studies, GILENYA may cause fetal harm. Because it takes approximately 2 months to eliminate GILENYA from the body, women of childbearing potential should use effective contraception to avoid pregnancy during and for 2 months after stopping GILENYA treatment.
5.7 Blood Pressure Effects
In MS clinical trials, patients treated with GILENYA 0.5 mg had an average increase of approximately 2 mmHg in systolic pressure, and approximately 1 mmHg in diastolic pressure, first detected after approximately 1 month of treatment initiation, and persisting with continued treatment. In controlled studies involving 854 MS patients on GILENYA 0.5 mg and 511 MS patients on placebo, hypertension was reported as an adverse reaction in 5% of patients on GILENYA 0.5 mg and in 3% of patients on placebo. Blood pressure should be monitored during treatment with GILENYA.
5.8 Immune System Effects Following GILENYA Discontinuation
Fingolimod remains in the blood and has pharmacodynamic effects, including decreased lymphocyte counts, for up to 2 months following the last dose of GILENYA. Lymphocyte counts generally return to the normal range within 1-2 months of stopping therapy [see Clinical Pharmacology (12.2)]. Because of the continuing pharmacodynamic effects of fingolimod, initiating other drugs during this period warrants the same considerations needed for concomitant administration (e.g., risk of additive immunosuppressant effects) [see Drug Interactions (7)].
6 ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in labeling:
•Bradyarrhythmia and atrioventricular blocks [see Warnings and Precautions (5.1)]
•Infections [see Warnings and Precautions (5.2)]
•Macular edema [see Warnings and Precautions (5.3)]
•Respiratory effects [see Warnings and Precautions (5.4)]
•Hepatic effects [see Warnings and Precautions (5.5)]
The most frequent adverse reactions (incidence ≥10% and > placebo) for GILENYA 0.5 mg were headache, influenza, diarrhea, back pain, liver enzyme elevations, and cough. The only adverse event leading to treatment interruption reported at an incidence >1% for GILENYA 0.5 mg was serum transaminase elevations (3.8%).
6.1 Clinical Trials Experience
A total of 1703 patients on GILENYA (0.5 or 1.25 mg once daily) constituted the safety population in the 2 controlled studies in patients with relapsing remitting MS (RRMS) [see Clinical Studies (14)].
Study 1 was a 2-year placebo-controlled clinical study in 1272 MS patients treated with GILENYA 0.5 mg (n=425), GILENYA 1.25 mg (n=429) or placebo (n= 418).
Table 1 Adverse Reactions in Study 1 (occurring in ≥1% of patients, and reported for GILENYA 0.5 mg at ≥1% higher rate than for placebo) Primary System Organ Class
Preferred Term
GILENYA 0.5 mg
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
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