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The following serious adverse reactions are described elsewhere in labeling:
- Bradyarrhythmia and Atrioventricular Blocks [see WARNINGS AND PRECAUTIONS]
- Infections [see WARNINGS AND PRECAUTIONS]
- Macular Edema [see WARNINGS AND PRECAUTIONS]
- Posterior Reversible Encephalopathy Syndrome [see WARNINGS AND PRECAUTIONS]
- Respiratory Effects [see WARNINGS AND PRECAUTIONS]
- Liver Injury [see WARNINGS AND PRECAUTIONS]
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%).
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].
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
|GILENYA 0.5 mg
|Influenza viral infections||13||10|
|Herpes viral infections||9||8|
|Nervous system disorders|
|General disorders and administration site conditions|
|Musculoskeletal and connective tissue disorders|
|Skin and subcutaneous tissue disorders|
|Blood triglycerides increased||3||1|
|Respiratory, thoracic, and mediastinal disorders|
|Blood and lymphatic system disorders|
Adverse reactions in Study 2, a 1-year active-controlled (versus interferon beta-1a, n=431) study including 849 patients with MS treated with fingolimod, were generally similar to those in Study 1.
Vascular events, including ischemic and hemorrhagic strokes, and peripheral arterial occlusive disease were reported in premarketing clinical trials in patients who received GILENYA doses (1.25-5 mg) higher than recommended for use in MS. Similar events have been reported with GILENYA 0.5 mg in the postmarketing setting although a causal relationship has not been established.
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.
Read the Gilenya (fingolimod capsules) Side Effects Center for a complete guide to possible side effects
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 and WARNINGS AND PRECAUTIONS].
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 adverse reactions is greater.
GILENYA reduces the immune response to vaccination. Vaccination may be less effective during and for up to 2 months after discontinuation of treatment with GILENYA [see CLINICAL PHARMACOLOGY]. The use of live attenuated vaccines should be avoided during and for 2 months after treatment with GILENYA because of the risk of infection.
Antineoplastic, Immunosuppressive, or Immunomodulating Therapies
Antineoplastic, immunosuppressive, or immune-modulating therapies are expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects such as natalizumab or mitoxantrone [see WARNINGS AND PRECAUTIONS].
Drugs That Slow Heart Rate or Atrioventricular Conduction (e.g., beta blockers or diltiazem)
Experience with GILENYA in patients receiving concurrent therapy with drugs that slow the heart rate or atrioventricular conduction (e.g., beta blockers, digoxin, or heart rate-slowing calcium channel blockers such as diltiazem or verapamil) is limited. Because initiation of GILENYA treatment may result in an additional decrease in heart rate, concomitant use of these drugs during GILENYA initiation may be associated with severe bradycardia or heart block. Seek advice from the prescribing physician regarding the possibility to switch to drugs that do not slow the heart rate or atrioventricular conduction before initiating GILENYA. Patients who cannot switch, should have overnight continuous ECG monitoring after the first dose [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
Laboratory Test Interaction
Because GILENYA reduces blood lymphocyte counts via redistribution in secondary lymphoid organs, peripheral blood lymphocyte counts cannot be utilized to evaluate the lymphocyte subset status of a patient treated with GILENYA. A recent CBC should be available before initiating treatment with GILENYA.
Read the Gilenya Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 5/20/2014
This monograph has been modified to include the generic and brand name in many instances.
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