Active Ingredient: Ponesimod
Ponesimod is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 2 milligrams ponesimod, once daily, over the duration of 2 days. Afterwards, oral, 3 milligrams ponesimod, once daily, over the duration of 2 days. Afterwards, oral, 4 milligrams ponesimod, once daily, over the duration of 2 days. Afterwards, oral, 5 milligrams ponesimod, once daily, over the duration of 1 day. Afterwards, oral, 6 milligrams ponesimod, once daily, over the duration of 1 day. Afterwards, oral, 7 milligrams ponesimod, once daily, over the duration of 1 day. Afterwards, oral, 8 milligrams ponesimod, once daily, over the duration of 1 day. Afterwards, oral, 9 milligrams ponesimod, once daily, over the duration of 1 day. Afterwards, oral, 10 milligrams ponesimod, once daily, over the duration of 3 days. Afterwards, oral, 20 milligrams ponesimod, once daily.
Treatment must be started with the 14-day treatment initiation pack. Treatment starts with one 2 mg tablet orally once daily on day 1 and dose-escalation progresses with the titration schedule outlined in Table 1.
Table 1. Dose titration regimen:
| Titration day | Daily dose |
|---|---|
| Day 1 and 2 | 2 mg |
| Day 3 and 4 | 3 mg |
| Day 5 and 6 | 4 mg |
| Day 7 | 5 mg |
| Day 8 | 6 mg |
| Day 9 | 7 mg |
| Day 10 | 8 mg |
| Day 11 | 9 mg |
| Day 12, 13 and 14 | 10 mg |
If dose titration is interrupted, missed dose instructions must be followed.
After dose titration is complete, the recommended maintenance dose of ponesimod is one 20 mg tablet taken orally once daily.
Re-initiation of therapy following treatment interruption during dose titration or maintenance period:
The same first dose monitoring as for treatment initiation is recommended when 4 or more consecutive doses of ponesimod are missed during the titration or maintenance periods.
Ponesimod should be administered orally once daily. Ponesimod can be taken with or without food.
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