Formulary
Apremilast: Indications, Dosing, Side Effects and Interactions
Apremilast inhibits the activity of phosphodiesterase type-4 (PDE4) which results in suppression of pro-inflammatory mediator synthesis and promotes...
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Apremilast: Indications, Dosing, Side Effects and Interactions
Apremilast inhibits the activity of phosphodiesterase type-4 (PDE4) which results in suppression of pro-inflammatory mediator synthesis and promotes...
Drug action
Apremilast inhibits the activity of phosphodiesterase type-4 (PDE4) which results in suppression of pro-inflammatory mediator synthesis and promotes anti-inflammatory mediators.
Indications and dose
**Active psoriatic arthritis (in combination with disease-modifying antirheumatic drugs or alone) in patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy,Moderate to severe chronic plaque psoriasis that has not responded to standard systemic treatments or photochemotherapy, or when these treatments cannot be used because of intolerance or contra-indications**
- **Adult** (By Mouth): Initially 10 mg daily on day 1, then 10 mg twice daily on day 2, then 10 mg in the morning and 20 mg in the evening on day 3, then 20 mg twice daily on day 4, then 20 mg in the morning and 30 mg in the evening on day 5, then maintenance 30 mg twice daily, doses should be taken approximately 12 hours apart; review treatment if no response within 24 weeks of initiation.
Cautions
Concomitant use of drugs likely to cause psychiatric symptoms; history of psychiatric illness; low body-weight-consider discontinuation if weight loss is unexplained or clinically significant
Contraindications
Active psoriatic arthritis (in combination with disease-modifying antirheumatic drugs or alone) in patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy, Moderate to severe chronic plaque psoriasis that has not responded to standard systemic treatments or photochemotherapy, or when these treatments cannot be used because of intolerance or contra-indications for apremilast By mouth Adult Initially 10 mg daily on day 1, then 10 mg twice daily on day 2, then 10 mg in the morning and 20 mg in the evening on day 3, then 20 mg twice daily on day 4, then 20 mg in the morning and 30 mg in the evening on day 5, then maintenance 30 mg twice daily, doses should be taken approximately 12 hours apart; review treatment if no response within 24 weeks of initiation.
Side effects
Common or very common Appetite decreased; back pain; cough; depression; diarrhoea; fatigue; gastrointestinal discomfort; gastrointestinal disorders; headaches; increased risk of infection; insomnia; nausea; vomiting Uncommon Gastrointestinal haemorrhage; rash; suicidal behaviours; weight decreased
Interactions
**Other interactions (12):**
- Co-administration of strong cytochrome P450 3A4 (CYP3A4) enzyme inducer, rifampicin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of apremilast.
- Therefore, the use of strong CYP3A4 enzyme inducers (e.g.
- John's Wort) with apremilast is not recommended.
- Co-administration of apremilast with multiple doses of rifampicin resulted in a decrease in apremilast area-under-the-concentration time curve (AUC) and maximum serum concentration (C max ) by...
- Apremilast exposure is decreased when administered concomitantly with strong inducers of CYP3A4 (e.g.
- In clinical studies, apremilast has been administered concomitantly with topical therapy (including corticosteroids, coal tar shampoo and salicylic acid scalp preparations) and UVB phototherapy.
Pregnancy
Avoid-teratogenic in animal studies.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Renal impairment
Dose adjustments Reduce dose if eGFR less than 30 mL/minute/1.73 m 2 ; consult product literature for initial dose titration. M See Prescribing in renal impairment .
Medicinal forms
Tablet
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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