Classes
DEA Class; Rx
Common Brand Names; Gilenya, Tascenso ODT
- Immunomodulators;
- Multiple Sclerosis Treatments;
- Sphingosine 1-Phosphate Receptor Modulators
Description
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
Indications
Indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Contraindications
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
Adverse Effects
- 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%)
Warnings
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Pregnancy and Lactation
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
Maximum Dosage
0.5 mg/day PO.
0.5 mg/day PO.
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.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Fingolimod
capsule
- 0.25mg
- 0.5mg
tablet, oral disintegrating
- 0.25mg
