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Fingolimod

    Brands

    DEA Class;  Rx

    Common Brand Names; Gilenya, Tascenso ODT

    • Immunomodulators; 
    • Multiple Sclerosis Treatments; 
    • Sphingosine 1-Phosphate Receptor Modulators

    Oral sphingosine 1-phosphate receptor modulator
    Used for the treatment of relapsing forms of multiple sclerosis in adults and pediatric patients 10 years and older
    Hypersensitivity, cardiac or ocular conditions, or severe hepatic disease may preclude treatment with the drug

    Indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

    Hypersensitivity; observed reactions include rash, urticaria, and angioedema upon treatment initiation

    History within past 6 months of MI, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization or Class III/IV heart failure

    History or presence of Mobitz Type II second-degree or third-degree atrioventricular (AV) block or sick sinus syndrome, unless patient has a functioning pacemaker

    Baseline QTc interval ≥500 ms

    Coadministration with Class Ia or Class III antiarrhythmic drugs

    • Headache (25%)
    • Liver transaminase elevations (ALT/GGT/AST) (15%)
    • Nausea (13%)
    • Influenza viral infection (11%)
    • Sinusitis (11%)
    • Abdominal pain (11%)
    • Diarrhea (12%)
    • Cough (12%)
    • Back pain (10%)
    • Pain in extremity (10%)
    • Herpes viral infections (9%)
    • Dyspnea (9%)
    • Depression (8%)
    • Hypertension (8%)
    • Bronchitis (8%)
    • Sinusitis (7%)
    • Dizziness (7%)
    • Lymphopenia (7%)
    • Hypertension (6%)
    • Migraine (6%)
    • Gastroenteritis (5%)
    • Weight decreased (5%)
    • Paresthesia (5%)
    • Tinea infections (4%)
    • Bradycardia (4%)
    • Blurred vision (4%)
    • Eye pain (3%)
    • Alopecia (3%)
    • Increased blood triglycerides (3%)
    • Skin papilloma (3%)
    • Bradycardia (3%)
    • Herpes zoster (2%)
    • Tinea versicolor (2%)
    • Asthenia (2%)

    —

    There are no adequate data on the developmental risk associated with drug use in pregnant women

    There are no data on the presence of fingolimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production

    Adults

    0.5 mg/day PO.

    Geriatric

    0.5 mg/day PO.

    Adolescents

    Weighing more than 40 kg: 0.5 mg/day PO for the capsule; safety and efficacy have not been established for the orally disintegrating tablet.
    Weighing 40 kg or less: 0.25 mg/day PO for the capsule and orally disintegrating tablet.

    Children

    10 to 12 years weighing more than 40 kg: 0.5 mg/day PO for the capsule; safety and efficacy have not been established for the orally disintegrating tablet.
    10 to 12 years weighing 40 kg or less: 0.25 mg/day PO for the capsule and orally disintegrating tablet.
    1 to 9 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Fingolimod

    capsule

    • 0.25mg
    • 0.5mg

    tablet, oral disintegrating

    • 0.25mg