Active Ingredient: Siponimod
Siponimod is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
1 - 2 mg
From 1 To 2 mg once every day
0.25 mg
Before initiation of treatment, patients must be genotyped for CYP2C9 to determine their CYP2C9 metaboliser status. In patients with a CYP2C9*3*3 genotype, siponimod should not be used.
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).
The recommended maintenance dose of siponimod in all other CYP2C9 genotype patients is 2 mg.
Siponimod is taken once daily.
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).
During the first 6 days of treatment initiation the recommended daily dose should be taken once daily in the morning with or without food.
Dose titration regimen to reach maintenance dosage:
| Titration | Titration dose | Titration regimen | Dose |
|---|---|---|---|
| Day 1 | 0.25 mg | 1 × 0.25 mg | TITRATION |
| Day 2 | 0.25 mg | 1 × 0.25 mg | |
| Day 3 | 0.5 mg | 2 × 0.25 mg | |
| Day 4 | 0.75 mg | 3 × 0.25 mg | |
| Day 5 | 1.25 mg | 5 × 0.25 mg | |
| Day 6 | 2 mg1 | 1 × 2 mg1 | MAINTENANCE |
1 In patients with CYP2C9*2*3 or *1*3 genotype, the recommended maintenance dose is 1 mg taken once daily (4 × 0.25 mg). Additional exposure of 0.25 mg on day 5 does not compromise patient safety.
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.
If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
If maintenance treatment is interrupted for 4 or more consecutive daily doses, siponimod needs to be re-initiated with a new titration pack.
Siponimod is taken with or without food.
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