Gilenya Dosage/Direction for Use

The treatment should be initiated and supervised by a physician experienced in multiple sclerosis.
Posology: In adults, the recommended dose of fingolimod is one 0.5 mg capsule taken orally once daily.
In paediatric patients (10 years of age and above), the recommended dose is dependent on body weight: Paediatric patients with body weight ≤40 kg: one 0.25 mg capsule taken orally once daily; Paediatric patients with body weight >40 kg: one 0.5 mg capsule taken orally once daily.
Paediatric patients who start on 0.25 mg capsules and subsequently reach a stable body weight above 40 kg should be switched to 0.5 mg capsules.
When switching from a 0.25 mg to a 0.5 mg daily dose, it is recommended to repeat the same first-dose monitoring as for treatment initiation.
The same first-dose monitoring as for treatment initiation is recommended when treatment is interrupted for: 1 day or more during the first 2 weeks of treatment; more than 7 days during weeks 3 and 4 of treatment; more than 2 weeks after one month of treatment.
If the treatment interruption is of shorter duration than those previously mentioned, the treatment should be continued with the next dose as planned (see Precautions).
Special populations: Elderly population: Gilenya should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: Gilenya was not studied in patients with renal impairment in the multiple sclerosis pivotal studies. Based on clinical pharmacology studies, no dose adjustments are needed in patients with mild to severe renal impairment.
Hepatic impairment: Fingolimod must not be used in patients with severe hepatic impairment (Child-Pugh class C) (see Contraindications). Although no dose adjustments are needed in patients with mild or moderate hepatic impairment, caution should be exercised when initiating treatment in these patients (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of fingolimod in children aged below 10 years have not yet been established. No data are available.
There are very limited data available in children between 10-12 years old (see Precautions, Adverse Reactions, and Pharmacology: Pharmacodynamics under Actions).
Method of administration: This medicinal product is for oral use.
Gilenya can be taken with or without food (see Pharmacology: Pharmacokinetics under Actions).
The capsules should always be swallowed intact, without opening them.