Apremilast (Otezla) is an oral phosphodiesterase 4 (PDE4) inhibitor widely used in the treatment of various inflammatory diseases. Correct administration and proper dosage adjustment are crucial for its therapeutic efficacy and ensuring safe medication use for patients.

How to Use Apremilast (Otezla)

Standard Regimen for Adult Patients

For adult patients with psoriatic arthritis, plaque psoriasis, or Behçet’s disease-associated oral ulcers, dose titration is recommended over the first 5 days of treatment.

The specific titration schedule is as follows:

Day 1: 10 mg taken in the morning;

Day 2: 10 mg taken in the morning and 10 mg taken in the evening;

Day 3: 10 mg taken in the morning and 20 mg taken in the evening;

Day 4: 20 mg taken in the morning and 20 mg taken in the evening;

Day 5: 20 mg taken in the morning and 30 mg taken in the evening.

Starting from Day 6, maintenance treatment begins, with the recommended dosage being 30 mg orally twice daily.

Standard Regimen for Pediatric Patients

For pediatric patients aged 6 years and older, weighing at least 20 kg, who have psoriatic arthritis or moderate-to-severe plaque psoriasis, the dosage should be calculated based on body weight.

For patients with a body weight of 50 kg or more, the maintenance dosage is 30 mg twice daily.

For patients with a body weight between 20 kg and 50 kg, the maintenance dosage is 20 mg twice daily.

The initial 5-day titration regimen also applies to pediatric patients, with the specific dosage schedule implemented according to the patient’s weight category.

Dosage Adjustment of Apremilast (Otezla)

Adjustment for Patients with Renal Impairment

Adult patients: For adults with severe renal impairment (creatinine clearance < 30 mL/min), only the morning doses listed in the adult titration table should be used during initial titration, and the afternoon doses should be skipped. The maintenance dosage should be reduced to 30 mg once daily.

Pediatric patients: For pediatric patients with severe renal impairment, only the morning doses corresponding to their weight category in the titration table should be used during initial titration, and the afternoon doses should be skipped. The adjusted maintenance dosages are:

30 mg once daily for patients weighing at least 50 kg;

20 mg once daily for patients weighing 20 kg to less than 50 kg.

Management of Drug Interactions

Concomitant use with strong cytochrome P450 enzyme inducers (such as rifampin, phenobarbital, carbamazepine, and phenytoin) may lead to a decrease in the systemic exposure of apremilast, which in turn may result in loss of therapeutic efficacy.

Concomitant use of apremilast with strong CYP450 enzyme inducers is not recommended.

Administration of Apremilast (Otezla) in Special Populations

Administration in Elderly Patients

Clinical studies have shown that there is no significant overall difference in efficacy between patients aged 65 years and older and younger adult patients.

Elderly patients may face a higher risk of complications such as dehydration or hypotension due to severe diarrhea, nausea, or vomiting, so close monitoring of such patients is required.

Administration in Pediatric Patients

The efficacy of apremilast has been confirmed in pediatric patients aged 6 years and older with a body weight ≥ 20 kg.

The growth and development (height and weight) of pediatric patients receiving apremilast treatment must be closely monitored.

For children who fail to achieve the expected growth or weight gain, consideration may be given to discontinuing the treatment.