Apremilast (10,20)

What it is and how it works

Mechanism of Action Apremilast is an oral small molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action is not well defined.

Mechanism class: Phosphodiesterase 4 Inhibitors

Indications

XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with: Active psoriatic arthritis Plaque psoriasis who are candidates for phototherapy or systemic therapy Oral ulcers associated with Behçet's Disease Pediatric patients 6 years of age and older with: Active psoriatic arthritis Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy In the pediatric population, OTEZLA is indicated for patients weighing at least 20 kg, and OTEZLA XR is indicated for patients weighing at least 50 kg. Psoriatic Arthritis OTEZLA is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis. OTEZLA XR is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 50 kg with active psoriatic arthritis. Plaque Psoriasis OTEZLA/OTEZLA XR is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Dosage and administration (summary)

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 2…

Contraindications

is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation . Known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and precautions

Hypersensitivity : Cases of angioedema and anaphylaxis have been reported during post marketing surveillance. Avoid the use of OTEZLA/OTEZLA XR 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/OTEZLA XR and institute appropriate therapy Diarrhea, Nausea, and Vomiting : Consider OTEZLA/OTEZLA XR dosage reduction or suspension if patients develop severe diarrhea, nausea, or vomiting Depression : Advise patients, their caregivers, and familie…

Pregnancy

Pregnancy Risk Summary Available data with OTEZLA use in pregnant women have not identified a drug-associated risk of major birth defects or adverse maternal or fetal outcomes (see Data ) .

Storage and supply

Storage and Handling Store OTEZLA tablets below 30°C (86°F). Store OTEZLA XR tablets between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .

Source: Apremilast (Otezla) — US FDA prescribing information, 2026-09-02, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.