OTEZLA, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of:

• Adult patients with active psoriatic arthritis
• Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
• Pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
• Adult patients with oral ulcers associated with Behçet’s Disease

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

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

• Psoriatic Arthritis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache
• Plaque Psoriasis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache
• Behçet’s Disease: The most common adverse reactions (≥ 10%) are diarrhea, nausea, headache, and upper respiratory tract infection

• Hypersensitivity: Cases of angioedema and anaphylaxis have been reported during post marketing surveillance. Avoid the use of OTEZLA in patients with known hypersensitivity to apremilast or to any of the excipients in the formulation. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue OTEZLA and institute appropriate therapy.
• Diarrhea, Nausea, and Vomiting: Consider OTEZLA dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
• Depression: Advise patients, their caregivers, and families to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes and if such changes occur to contact their healthcare provider. Carefully weigh risks and benefits of treatment with OTEZLA in patients with a history of depression and/or suicidal thoughts or behavior 
• Weight Decrease: Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of OTEZLA
• Drug Interactions: Use with strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended because loss of efficacy may occur