sp; 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 including 849 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 received GILENYA doses (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
QT prolonging drugs
GILENYA has not been studied in patients treated with drugs that prolong the QT interval. Drugs that prolong the QT interval have been associated with cases of torsades de pointes in patients with bradycardia. Since initiation of GILENYA treatment results in decreased heart rate and may prolong the QT interval, patients on QT prolonging drugs with a known risk of torsades de pointes (e.g., citalopram, chlorpromazine, haloperidol, methadone, erythromycin) should be monitored overnight with continuous ECG in a medical facility [see Dosage and Administration (2) and Warnings and Precautions (5.1)].
Ketoconazole
The blood levels of fingolimod and fingolimod-phosphate are increased by 1.7-fold when used concomitantly with ketoconazole. Patients who use GILENYA and systemic ketoconazole concomitantly should be closely monitored, as the risk of adver |
