Mayzent Dosage/Direction for Use

Treatment with siponimod should be initiated and supervised by a physician experienced in the management of multiple sclerosis.
Before initiation of treatment, patients must be genotyped for CYP2C9 to determine their CYP2C9 metaboliser status (see Precautions, Interactions, and Pharmacology: Pharmacokinetics under Actions).
In patients with a CYP2C9*3*3 genotype, siponimod should not be used (see Contraindications, Precautions, and Pharmacology: Pharmacokinetics under Actions).
In patients with a CYP2C9*2*3 or *1*3 genotype, the recommended maintenance dose is 1 mg taken once daily (four tablets of 0.25 mg) (see Precautions and Pharmacology: Pharmacokinetics under Actions).
The recommended maintenance dose of siponimod in all other CYP2C9 genotype patients is 2 mg.
Mayzent is taken once daily.
Posology: Treatment initiation: Treatment has to be started with a titration pack that lasts for 5 days. Treatment starts with 0.25 mg once daily on days 1 and 2, followed by once-daily doses of 0.5 mg on day 3, 0.75 mg on day 4, and 1.25 mg on day 5, to reach the patient's prescribed maintenance dose of siponimod starting on day 6 (see Table 3).
During the first 6 days of treatment initiation the recommended daily dose should be taken once daily in the morning with or without food. (See Table 3.)

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Missed dose(s) during treatment initiation: During the first 6 days of treatment, if a titration dose is missed on one day treatment needs to be re-initiated with a new titration pack.
Missed dose after day 6: If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
Re-initiation of maintenance therapy after treatment interruption: If maintenance treatment is interrupted for 4 or more consecutive daily doses, siponimod needs to be re-initiated with a new titration pack.
Special populations: Elderly: Siponimod has not been studied in patients aged 65 years and above. Clinical studies included patients up to the age of 61 years. Siponimod should be used with caution in the elderly due to insufficient data on safety and efficacy (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: Based on clinical pharmacology studies, no dose adjustment is needed in patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Siponimod must not be used in patients with severe hepatic impairment (Child-Pugh class C) (see Contraindications). Although no dose adjustment is 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 siponimod in children and adolescents aged 0 to 18 years have not yet been established. No data are available.
Method of administration: Oral use. Siponimod is taken with or without food.
The film-coated tablets should be swallowed whole with water.