Active Ingredient: Etrasimod
Etrasimod is indicated for the treatment of patients 16 years of age and older 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 biological agent.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient age in years is ≥ 16, oral, 2 milligrams etrasimod, once daily to meals, over the duration of 3 days. Afterwards, in case that patient age in years is ≥ 16, oral, 2 milligrams etrasimod, once daily.
The recommended dose is 2 mg etrasimod taken once daily.
If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
If treatment is interrupted for 7 or more consecutive days, it is recommended to resume treatment with food for the first 3 doses.
No dose adjustment is needed in patients over 65 years of age.
Etrasimod should be used with caution in elderly patients over 65 years of age, given the limited data available and potential for an increased risk of adverse reactions in this population.
The safety and efficacy of etrasimod in children and adolescents less than 16 years of age have not yet been established. No data are available.
Given the limited data in adolescents aged 16 and over, etrasimod should be used with caution especially when body weight is less than 40 kg due to the potential for increase in exposure.
It is recommended that etrasimod be administered with food for the first 3 days to attenuate potential transient heart rate lowering effects related to initiation of treatment. Etrasimod can then be taken with or without food.
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