Active Ingredient: Apremilast
Apremilast is indicated for the treatment of adult patients with oral ulcers associated with Behรงet’s disease (BD) who are candidates for systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 10 milligrams apremilast, at morning, one dose, over the duration of 24 hours. Afterwards, oral, 10 milligrams apremilast, at morning, one dose, over the duration of 12 hours. Afterwards, oral, 10 milligrams apremilast, at evening, one dose, over the duration of 12 hours. Afterwards, oral, 10 milligrams apremilast, at morning, one dose, over the duration of 12 hours. Afterwards, oral, 20 milligrams apremilast, at evening, one dose, over the duration of 12 hours. Afterwards, oral, 20 milligrams apremilast, at morning, one dose, over the duration of 12 hours. Afterwards, oral, 20 milligrams apremilast, at evening, one dose, over the duration of 12 hours. Afterwards, oral, 20 milligrams apremilast, at morning, one dose, over the duration of 12 hours. Afterwards, oral, 30 milligrams apremilast, once every 12 hours at evening.
The recommended dose of apremilast for adult patients is 30 mg taken orally twice daily. An initial titration schedule is required as shown below in table 1.
Table 1. Dose titration schedule for adult patients:
| Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 & thereafter | |||||
| AM | AM | PM | AM | PM | AM | PM | AM | PM | AM | PM |
| 10 mg | 10 mg | 10 mg | 10 mg | 20 mg | 20 mg | 20 mg | 20 mg | 30 mg | 30 mg | 30 mg |
No re-titration is required after initial titration.
The recommended twice daily apremilast dose should be taken approximately 12 hours apart (morning and evening), with no food restrictions.
If patients miss a dose, the next dose should be taken as soon as possible. If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time.
During pivotal trials the greatest improvement was observed within the first 12 weeks of treatment for BD. If a patient shows no evidence of therapeutic benefit after this time period, treatment should be reconsidered. The patient’s response to treatment should be evaluated on a regular basis.
It can be taken either with or without food.
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