Active Ingredient: Apremilast
Apremilast, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
Apremilast is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
For this indication, competent medicine agencies globally authorize below treatments:
Oral
10 - 60 mg
From 5 To 30 mg 2 time(s) per day every day for 180 day(s)
10 mg
60 mg
The recommended dose of apremilast is 30 mg twice daily taken orally, morning and evening, approximately 12 hours apart, with no food restrictions. An initial titration schedule is required as shown below in the table. No re-titration is required after initial titration.
Dose titration schedule:
| Day 1 | Day2 | 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 |
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 24 weeks of treatment. If a patient shows no evidence of therapeutic benefit after 24 weeks, treatment should be reconsidered. The patient’s response to treatment should be evaluated on a regular basis. Clinical experience beyond 52 weeks is not available.
It can be taken either with or without food.
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