Apremilast

Source: UK SPC (eMC) for Apremilast 10 mg, 20 mg, 30 mg Film-coated Tablets (treatment initiation pack), §4.2 (https://www.medicines.org.uk/emc/product/101884/smpc). The same 30 mg twice daily maintenance dose applies to all three adult indications: psoriatic arthritis, psoriasis and Behcet's disease. INITIAL TITRATION IS REQUIRED (SPC Table 1, adults): Day 1 - 10 mg in the morning; Day 2 - 10 mg AM and 10 mg PM; Day 3 - 10 mg AM and 20 mg PM; Day 4 - 20 mg AM and 20 mg PM; Day 5 - 20 mg AM and 30 mg PM; Day 6 and thereafter - 30 mg AM and 30 mg PM. No re-titration is required after initial titration. MISSED DOSE: take the next dose as soon as possible; if it is close to the time of the next dose, skip the missed dose and take the next dose at the regular time. DURATION / REVIEW: during pivotal trials the greatest improvement was observed within the first 24 weeks of treatment for psoriatic arthritis and psoriasis and within the first 12 weeks for Behcet's disease; if a patient shows no evidence of therapeutic benefit after this period, treatment should be reconsidered, and response should be evaluated on a regular basis. PRESCRIBER: treatment should be initiated by specialists experienced in the diagnosis and treatment of psoriasis, psoriatic arthritis or Behcet's disease. ELDERLY: no dose adjustment required. HEPATIC IMPAIRMENT: no dose adjustment necessary. SEVERE RENAL IMPAIRMENT: see renalAdjustment - note that titration in this group uses only the AM schedule and the PM doses are skipped. UNDERWEIGHT PATIENTS: patients who are underweight (and paediatric patients with a borderline to low body mass index at the start of treatment) should have their body weight monitored regularly; in the event of unexplained and clinically significant weight loss they should be evaluated and discontinuation considered. PAEDIATRIC (body-weight-band dosing, NOT a per-kg dose, so it is not expressed as mg/kg): for paediatric patients 6 years of age and older with moderate to severe plaque psoriasis the recommended dose is 20 mg twice daily for those who weigh from 20 kg to less than 50 kg, and 30 mg twice daily for those who weigh at least 50 kg, following the initial titration in SPC Table 2 (both weight bands: Day 1 10 mg AM; Day 2 10 mg AM and 10 mg PM; Day 3 10 mg AM and 20 mg PM; Day 4 20 mg AM and 20 mg PM; Day 5 onwards 20 mg AM and 20 mg PM for 20 kg to less than 50 kg, or 20 mg AM then 30 mg PM from Day 5 and 30 mg twice daily from Day 6 for 50 kg or more). In paediatric patients 6 years and older with severe renal impairment (creatinine clearance less than 30 mL/min by Cockcroft-Gault) the dose should be reduced to 30 mg once daily for those weighing at least 50 kg and to 20 mg once daily for those weighing 20 kg to less than 50 kg, titrating using only the AM schedule. Safety and efficacy have not been established in children with moderate to severe plaque psoriasis below the age of 6 years or with a body weight less than 20 kg, or in other paediatric indications, and no data are available. Verify any under-18 dosing against a children's formulary. US CROSS-CHECK (openFDA, Otezla/Otezla XR, Amgen, label date 2025-08-22): the same 30 mg twice daily maintenance dose after the same 5-day titration, and additionally an extended-release presentation (OTEZLA XR 75 mg once daily) that is not part of the fetched UK SPC; the US label also approves paediatric psoriatic arthritis from 6 years and at least 20 kg. Do not carry the XR regimen onto this page without a UK source.