apremilast: clinical use

Prescribing considerations

• Specialist initiation is required for the licensed inflammatory conditions.
• Review psychiatric history, current mood symptoms and medicines associated with psychiatric effects before and during treatment.
• Assess renal function; severe renal impairment requires product-specific adjustment.
• Monitor underweight patients and children with borderline or low body mass index for clinically significant weight loss.
• Check the individual product licence because paediatric indications differ between selected products.
• Consider lactose content in patients with relevant rare hereditary carbohydrate disorders.

Contraindications and cautions

• Pregnancy
• Hypersensitivity to apremilast or a listed excipient

Monitoring

• Clinical response
• New or worsening depression, behavioural change or suicidal thinking
• Diarrhoea, nausea, vomiting and hydration status
• Body weight, particularly in underweight patients and children with borderline or low body mass index
• Renal function where impairment is present or suspected

Clinical pharmacology

Apremilast is an oral small-molecule PDE4 inhibitor. Increased intracellular cyclic AMP modulates pro-inflammatory and anti-inflammatory mediators rather than fully suppressing individual cytokines.

Formulation and product differences

• The selected Otezla product includes initiation-pack and paediatric presentations; the selected generic product does not establish paediatric use.
• Tablet appearance, lactose content, pack options and storage wording differ between products. Consult the specific supplied product information.

Tablet

Route: Oral

Strengths: 10 mg, 20 mg, 30 mg