Generic name: APREMILAST 10.0mg; APREMILAST 20.0mg; APREMILAST 30.0mg
Dosage form: tablet, film coated
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2.1 Dosage in Psoriatic Arthritis and Psoriasis
The recommended initial dosage titration of OTEZLA 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 gastrointestinal symptoms associated with initial therapy.
OTEZLA can be administered without regard to meals. Do not crush, split, or chew the tablets.
|Day 1||Day 2||Day 3||Day 4||Day 5||Day 6
|10 mg||10 mg||10 mg||10 mg||20 mg||20 mg||20 mg||20 mg||30 mg||30 mg||30 mg|
Dosage Adjustment in Patients with Severe Renal Impairment
OTEZLA 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) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. For initial dosage titration in this group, it is recommended that OTEZLA be titrated using only the AM schedule listed in Table 1 and the PM doses be skipped.