Active Ingredient: Ozanimod
Ozanimod is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 0.23 milligrams ozanimod, once daily, over the duration of 4 days. Afterwards, oral, 0.46 milligrams ozanimod, once daily, over the duration of 3 days. Afterwards, oral, 0.92 milligrams ozanimod, once daily.
The recommended dose is 0.92 mg ozanimod once daily.
The capsules can be taken with or without food.
The initial dose escalation regimen of ozanimod from Day 1 to Day 7 is required and shown below in Table 1. Following the 7-day dose escalation, the once daily dose is 0.92 mg, starting on Day 8.
Table 1. Dose escalation regimen:
| Days 1–4 | 0.23 mg once daily |
| Days 5–7 | 0.46 mg once daily |
| Days 8 and thereafter | 0.92 mg once daily |
The same dose escalation regimen described in Table 1 is recommended when treatment is interrupted for:
If the treatment interruption is of shorter duration than the above, the treatment should be continued with the next dose as planned.
There are limited data available on RRMS patients >55 years of age. Patients enrolled in the ongoing clinical trials continue to be dosed with 0.92 mg ozanimod daily after they become 55 and older. No dose adjustment is needed in patients over 55 years of age. Caution should be used in patients >55 years of age, given the potential for an increased risk of adverse reactions in this population, especially with long-term treatment.
It can be taken with or without food.
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