Phosphodiesterase-4 (PDE4) Inhibitor Pregnancy: Contraindicated during pregnancy. Pregnancy should be excluded before treatment is initiated and women of childbearing potential should use an effective method of contraception during treatment. Should not be used during breast-feeding — a risk to the breastfed infant cannot be excluded.

Apremilast (Dermatology)

Brand names: Otezla

Apremilast is an oral phosphodiesterase-4 inhibitor used in dermatology for plaque psoriasis and active psoriatic arthritis where other systemic therapies are unsuitable.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 30 mg twice daily (maintenance, from Day 6), after the required 5-day initial titration

Route: Oral — film-coated tablets swallowed whole, with or without food

Frequency: Twice daily, approximately 12 hours apart (morning and evening)

Adults with psoriasis, psoriatic arthritis or Behçet's disease. Treatment should be initiated by specialists experienced in the diagnosis and treatment of these conditions. Required adult titration (SPC Table 1): Day 1 — 10 mg AM; Day 2 — 10 mg AM + 10 mg PM; Day 3 — 10 mg AM + 20 mg PM; Day 4 — 20 mg AM + 20 mg PM; Day 5 — 20 mg AM + 30 mg PM; Day 6 and thereafter — 30 mg AM + 30 mg PM. No re-titration is required after initial titration. Missed dose: take as soon as possible; if close to the next dose, skip and resume at the regular time. Review: greatest improvement was seen within the first 24 weeks for psoriatic arthritis and psoriasis and within the first 12 weeks for Behçet's disease — reconsider treatment if no evidence of therapeutic benefit after this period; response should be evaluated regularly. PAEDIATRIC (weight-band, not per-kg, so not captured in paedDose): for patients 6 years and older with moderate to severe plaque psoriasis the dose is by body weight — 20 mg twice daily for 20 kg to less than 50 kg, and 30 mg twice daily for at least 50 kg, following SPC Table 2 titration (20 kg to <50 kg: Day 1 10 mg AM; Day 2 10 mg AM + 10 mg PM; Day 3 10 mg AM + 20 mg PM; Day 4 20 mg AM + 20 mg PM; Day 5 20 mg AM + 20 mg PM; Day 6 onward 20 mg twice daily. ≥50 kg: Day 1 10 mg AM; Day 2 10 mg AM + 10 mg PM; Day 3 10 mg AM + 20 mg PM; Day 4 20 mg AM + 20 mg PM; Day 5 20 mg AM + 30 mg PM; Day 6 onward 30 mg twice daily). Safety and efficacy not established in children with moderate to severe plaque psoriasis below 6 years of age or under 20 kg, or in other paediatric indications. Elderly: no dose adjustment required. Hepatic impairment: no dose adjustment necessary. Underweight patients and paediatric patients with borderline to low BMI should have body weight monitored regularly.

Dose adjustments

Renal

Adults: no dose adjustment in mild or moderate renal impairment; reduce to 30 mg once daily in severe renal impairment (creatinine clearance less than 30 mL/min by Cockcroft-Gault), titrating using only the AM schedule of Table 1 and skipping the PM doses. Paediatric patients 6 years and older: no adjustment in mild or moderate impairment; in severe renal impairment reduce to 30 mg once daily if at least 50 kg and to 20 mg once daily if 20 kg to less than 50 kg, titrating using only the AM schedule of Table 2 for the appropriate weight band.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Pregnancy

Side effects

Diarrhoea — very common (15.7% in PsA/psoriasis; 41.3% in Behçet's disease); severe cases with hospitalisation reported post-marketing
Nausea — very common (13.9% in PsA/psoriasis; 19.2% in Behçet's disease); vomiting common
Upper respiratory tract infection — very common (8.4%); bronchitis and nasopharyngitis common
Headache including tension headache — very common (7.9% / 7.2%); migraine common
Psychiatric: insomnia and depression common; suicidal ideation and behaviour, anxiety and mood altered uncommon
Decreased appetite and weight decrease; back pain and fatigue common

Interactions

Strong CYP3A4 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, St John's Wort) — not recommended; rifampicin reduced apremilast systemic exposure and may cause loss of efficacy

Clinical monograph

How it works

It inhibits phosphodiesterase-4, raising intracellular cyclic AMP and thereby reducing production of pro-inflammatory cytokines involved in psoriatic inflammation.

Prescribing in practice

Monitor for new or worsening depression and suicidal ideation, and review continued treatment if these occur.
Diarrhoea, nausea and weight loss are common, particularly early in treatment, and dose titration improves tolerability.
Dose adjustment is required in severe renal impairment.

Monitoring

No specific blood monitoring is mandated, but monitor body weight and mental health during treatment.

Counselling the patient

Gastrointestinal upset is common when starting and usually settles; the dose is increased gradually at the outset.
Report low mood, anxiety or thoughts of self-harm to your clinician.
Tell your team if you experience unexplained or marked weight loss.

Evidence & guidelines

NICE recommends apremilast within its marketing authorisation for plaque psoriasis and psoriatic arthritis in specified circumstances.

Reference: ESTEEM 1 & 2 trials (Papp et al. JAAD 2015); RELIEF trial (Hatemi et al. NEJM 2019); NICE TA785; MHRA SPC Otezla; NICE TA781 (Behçet's); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways