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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]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials (Studies 1, 2, and 3), a total of 1212 patients with relapsing forms of multiple sclerosis received GILENYA 0.5 mg. This included 783 patients who received GILENYA 0.5 mg in the 2-year placebo-controlled trials (Studies 1 and 3) and 429 patients who received GILENYA 0.5 mg in the 1 year active-controlled trial (Study 2). The overall exposure in the controlled trials was equivalent to 1716 person-years. Approximately 1000 patients received at least 2 years of treatment with GILENYA 0.5 mg. In all clinical studies, including uncontrolled extension studies, the exposure to GILENYA 0.5 mg was approximately 4119 person-years.
In placebo-controlled trials, the most frequent adverse reactions (incidence ≥ 10% and > placebo) for GILENYA 0.5 mg were headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity. Adverse events that led to treatment discontinuation and occurred in more than 1% of patients taking GILENYA 0.5 mg were serum transaminase elevations (4.7% compared to 1% on placebo) and basal cell carcinoma (1% compared to 0.5% on placebo).
Table 1 lists adverse reactions that occurred in ≥ 1% of GILENYA-treated patients and ≥ 1% higher rate than for placebo.
Table 1 : Adverse Reactions Reported in Studies 1 and 3
(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
|Tinea versicolor||2||< 1|
|Nervous system disorders|
|General disorders and administration site conditions|
|Musculoskeletal and connective tissue disorders|
|Pain in extremity||10||7|
|Skin and subcutaneous tissue disorders|
|Liver transaminase elevations (ALT/GGT/AST)||15||4|
|Blood triglycerides increased||3||1|
|Respiratory, thoracic, and mediastinal disorders|
|Blood and lymphatic system disorders|
|Neoplasms benign, malignant and unspecified (including cysts and polyps)|
|Basal cell carcinoma||2||1|
Adverse reactions of dizziness, pneumonia, eczema and pruritus were also reported in Studies 1 and 3 but did not meet the reporting rate criteria for inclusion in Table 1 (difference was less than 1%).
Adverse reactions with GILENYA 0.5 mg in Study 2, the 1-year active-controlled (versus interferon beta-1a) study were generally similar to those in Studies 1 and 3.
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 have occurred in premarketing clinical trials and in the postmarketing setting. The relationship to GILENYA remains uncertain.
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]. Avoid the use of live attenuated vaccines during and for 2 months after treatment with GILENYA because of the risk of infection.
Antineoplastic, Immunosuppressive, or Immune-Modulating Therapies
Antineoplastic, immune-modulating, or immunosuppressive therapies, (including corticosteroids) are expected to increase the risk of immunosuppression, and the risk of additive immune system effects must be considered if these therapies are coadministered with GILENYA. When switching from drugs with prolonged immune effects, such as natalizumab, teriflunomide or mitoxantrone, the duration and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects when initiating GILENYA [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: 8/13/2015
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