Dosage & Administration:
The recommended initial dosage titration of Apremilast from Day 1 to Day 5 is shown in Table 1. Following the 5-day titration, the recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6. This titration is intended to reduce the
AM PM Day 1 10 mg - Day 2 10 mg 10 mg Day 3 10 mg 20 mg Day 4 20 mg 20 mg Day 5 20 mg 30 mg Day 6 & thereafter 30 mg 30 mg
gastrointestinal symptoms associated with initial therapy.
Apremilast can be administered without regard to meals. Do not crush, split, or chew the tablets.
Table 1: Dosage Titration Schedule
Dosage Adjustment in Patients with Severe Renal Impairment
Apremilast dosage should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance (CLcr) of less than 30 mL per minute estimated by the Cockcroft–Gault equation).
For initial dosage titration in this group, it is recommended that Apremilast be titrated using only the AM schedule listed in Table 1 and the PM doses be skipped.
Otelast™ 30: Each box contains 20 tablets in alu-alu blister pack.