Concise Prescribing Info
Relapsing forms of multiple sclerosis (MS) to reduce frequency of clinical exacerbation & delay accumulation of physical disability.
Dosage/Direction for Use
Adult & ped >10 yr, >40 kg 0.5 mg once daily, ≤40 kg 0.25 mg once daily.
May be taken with or without food: Swallow whole, do not open cap.
Hypersensitivity. Experienced MI, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization or class III/IV heart failure w/in last 6 mth. History or presence of Mobitz type II 2nd- or 3rd-degree AV block or sick sinus syndrome (unless w/ functioning pacemaker). Baseline QTc interval ≥500 msec. Concomitant use w/ class IA or III antiarrhythmics. Women of childbearing potential not using effective contraception. Pregnancy.
Special Precautions
Hypersensitivity. Discontinue use if progressive multifocal leukoencephalopathy, significant liver injury, posterior reversible encephalopathy syndrome is suspected. Not to be initiated in patients w/ active acute or chronic infection. Macular edema; basal cell carcinoma; lymphoma; Kaposi's sarcoma & cryptococcal infections; MS relapses w/ tumefactive demyelinating lesions. Severe increase in disability accompanied by multiple new lesions after discontinuation; decreased lymphocyte counts for up to 2 mth following last dose. Obtain cardiac evaluation in patients w/ preexisting conditions (eg, ischemic heart disease, history of MI, cardiac arrest, symptomatic bradycardia, or recurrent syncope; CHF, cerebrovascular disease, uncontrolled HTN, severe untreated sleep apnea, AV block, SA heart block) prior to treatment. Perform ECG prior to 1st dose & at end of 6-hr observation period; recent CBC; cancer screening including Pap tests in patients on immunosuppressives; spirometric evaluation of resp function & diffusion lung capacity of carbon monoxide during therapy; ophth exam prior to & regularly in patients w/ history of uveitis & DM. Periodic skin exam. Monitor BP during treatment. Consider HPV vaccination prior to initiation. Varicella zoster virus vaccination of Ab -ve patients & postpone initiation for 1 mth. Limit exposure to sunlight & UV light. Prior & concomitant use w/ antineoplastics, immunosuppressives or immune-modulating therapies. Severe hepatic impairment. Women of childbearing potential should use effective contraception during & for 2 mth after last dose. Pregnancy. Not to be used during lactation. Ped <10 yr. Elderly ≥65 yr.
Adverse Reactions
Flu, sinusitis, bronchitis, herpes zoster, tinea versicolor; bradycardia; headache, migraine; nausea, diarrhea, abdominal & back pain, pain in extremity; asthenia; alopecia, actinic keratosis; elevated liver transaminase (ALT, GGT, AST), increased blood triglycerides; cough, dyspnea; blurred vision; HTN; lymphopenia, leukopenia; skin papilloma, basal cell carcinoma.
Drug Interactions
Increased blood levels w/ ketoconazole. Reduced efficiency w/ live attenuated vaccines during & for 2 mth after treatment. Increased risk of immunosuppression & additive immunosuppressive effects w/ antineoplastics, immune-modulating or immunosuppressive therapies including corticosteroids. Severe bradycardia or heart block w/ drugs slowing heart rate or AV conduction eg, β-blockers, digoxin or Ca-channel blockers eg, diltiazem or verapamil. QT prolonging drugs w/ known risk of Torsade de pointes eg, citalopram, chlorpromazine, haloperidol, methadone, erythromycin.
MIMS Class
ATC Classification
L04AE01 - fingolimod ; Belongs to the class of sphingosine-1-phosphate (S1P) receptor modulators. Used as immunosuppressants.
Gilenya hard cap 0.5 mg
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