Alitretinoin

Indication: severe chronic hand eczema in adults that is unresponsive to treatment with potent topical corticosteroids. Both 10 mg and 30 mg cleared disease in studies; 30 mg gave a more rapid response and a higher response rate, 10 mg was associated with fewer adverse events. Duration: a treatment course may be given for 12 to 24 weeks depending on response; discontinuation is recommended in patients who achieve clear or almost clear hands earlier than 24 weeks, and should also be considered in patients who still have severe disease after the initial 12 weeks of continuous treatment. Retreatment: in the event of relapse, patients may benefit from further treatment courses. Prescribing restrictions: should only be prescribed by dermatologists, or physicians with experience in the use of systemic retinoids who have full understanding of the risks and monitoring requirements. For women of childbearing potential, prescriptions are limited to 30 days of treatment and continuation requires a new prescription; pregnancy testing, issuing the prescription and dispensing should ideally occur on the same day, and dispensing should occur within a maximum of 7 days of the prescription. Should not be prescribed if the patient's eczema can be adequately controlled by standard measures (skin protection, avoidance of allergens and irritants, potent topical corticosteroids). Paediatric: 'Alitretinoin is not recommended for use in patients under 18 years of age' — no paediatric dose is stated. Hepatic impairment: contraindicated. Elderly: no alteration of dosage or dosing frequency required in patients over 65 years. SOURCE SCOPE: this entry is from the UK SPC for Alitretinoin 10 mg capsules, soft (oral, severe chronic hand eczema). The US record in the same bundle is a different product, route and indication (a topical alitretinoin gel for cutaneous Kaposi sarcoma) and was deliberately NOT used for this monograph.