Active Ingredient: Ozanimod
Ozanimod is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
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 UC patients ≥65 years of age. Caution should be used in UC patients over 65 years of age, given the limited data available and potential for an increased risk of adverse reactions in this population, especially with long-term treatment.
It can be taken with or without food.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.