Apremilastdosage

To reduce the risk of gastrointestinal symptoms, titrate to recommended dosage as follows: Adults with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease See Table 1 for the initial titration schedule. Recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis See Table 2 for the initial titration schedule For patients weighing 50 kg or more: Recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily For patients weighing 20 kg to less than 50 kg: Recommended maintenance dosage is OTEZLA 20 mg twice daily Dosage in Patients with Severe Renal Impairment: Adult Patients: For initial dosage titration, titrate using only morning schedule listed in Table 1 and skip afternoon doses. Recommended maintenance dosage is OTEZLA 30 mg once daily Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis: For initial dosage titration, titrate using only morning schedule for appropriate body weight category in Table 2 and skip afternoon doses For patients weighing 50 kg or more: Recommended maintenance dosage is OTEZLA 30 mg once daily For patients weighing 20 kg to less than 50 kg: Recommended maintenance dosage is OTEZLA 20 mg once daily

2.1 Recommended

Dosage in Adult and Pediatric Patients with Psoriatic Arthritis, Plaque Psoriasis, and Behçet's Disease Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease The recommended initial dosage titration from Day 1 to Day 5 is shown in Table 1. Following the 5-day titration with OTEZLA, the recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once 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 OTEZLA Dosage Titration OTEZLA tablets should be used for the initial titration regardless of whether OTEZLA or OTEZLA XR will be used for the maintenance dosage. OTEZLA/OTEZLA XR Maintenance Dosage Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM BID = twice daily; QD = once daily 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg OTEZLA 30 mg BID OR OTEZLA XR 75 mg QD Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis Moderate to Severe Plaque Psoriasis The recommended dosage for pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis or moderate to severe plaque psoriasis is based on body weight. Following the appropriate initial titration schedule shown in Table 2, the recommended maintenance dosage is: For pediatric patients who weigh at least 50 kg: OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily taken orally For pediatric patients who weigh from 20 kg to less than 50 kg: OTEZLA 20 mg twice daily taken orally The initial 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 Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis OTEZLA Dosage Titration OTEZLA tablets should be used for the initial titration regardless of whether OTEZLA or OTEZLA XR will be used for the maintenance dosage. OTEZLA/OTEZLA XR Maintenance Dosage Body Weight Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM BID = twice daily; QD = once daily 50 kg or more 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg OTEZLA 30 mg BID OR OTEZLA XR 75 mg QD 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 OTEZLA 20 mg BID

2.2 Switching

Between OTEZLA and OTEZLA XR Patients treated with OTEZLA 30 mg twice daily may be switched to OTEZLA XR 75 mg once daily the day following the last dose of OTEZLA 30 mg. Patients treated with OTEZLA XR 75 mg once daily may be switched to OTEZLA 30 mg twice daily the day following the last dose of OTEZLA XR 75 mg.

2.3 Dosage Adjustment in

Adult and Pediatric 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. The recommended maintenance dosage in this group is OTEZLA 30 mg once daily. OTEZLA XR is not recommended for adult patients with severe renal impairment; the appropriate dosage for these patients has not been determined. Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or 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 psoriatic arthritis or 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. The recommended maintenance dosage is: For pediatric patients who weigh at least 50 kg: OTEZLA 30 mg once daily taken orally For pediatric patients who weigh 20 kg to less than 50 kg: OTEZLA 20 mg once daily taken orally OTEZLA XR is not recommended for pediatric patients with severe renal impairment; the appropriate dosage for these patients has not been determined.

2.4 Important

Administration Instructions Administer OTEZLA/OTEZLA XR with or without food. Swallow tablets whole. Do not crush, split, or chew.