Otezla Dosage

Generic name: APREMILAST 30mg
Dosage form: tablet, film coated
Drug class: Antirheumatics

Medically reviewed by Drugs.com. Last updated on May 1, 2024.

Dosage in Psoriatic Arthritis, Plaque Psoriasis, and Behçet's Disease

Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease

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.

Table 1: Dosage Titration Schedule for Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease
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

Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Moderate to Severe Plaque Psoriasis

The recommended dosage for pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis is based on body weight. Following the appropriate initial titration schedule shown in Table 2, the recommended maintenance dosage of OTEZLA taken orally is 30 mg twice daily for pediatric patients who weigh at least 50 kg and 20 mg twice daily for pediatric patients who weigh from 20 kg to less than 50 kg. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.

Table 2: Dosage Titration Schedule for Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Moderate to Severe Plaque Psoriasis
Body Weight	Day 1	Day 2		Day 3		Day 4		Day 5		Day 6 & thereafter
	AM	AM	PM	AM	PM	AM	PM	AM	PM	AM	PM
50 kg or more	10 mg	10 mg	10 mg	10 mg	20 mg	20 mg	20 mg	20 mg	30 mg	30 mg	30 mg
20 kg to less than 50 kg	10 mg	10 mg	10 mg	10 mg	20 mg	20 mg	20 mg	20 mg	20 mg	20 mg	20 mg

Dosage Adjustment in Patients with Severe Renal Impairment

Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease

For initial dosage titration in adult patients with severe renal impairment (creatinine clearance [CLcr] of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 1 and skip the PM doses. Reduce OTEZLA maintenance dosage to 30 mg once daily in this group [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Moderate to Severe Plaque Psoriasis

For initial dosage titration in pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis and severe renal impairment (CLcr of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 2 for the appropriate body weight category and skip the PM doses. Reduce the OTEZLA maintenance dosage to 30 mg once daily for pediatric patients who weigh at least 50 kg and to 20 mg once daily for pediatric patients who weigh 20 kg to less than 50 kg [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].