Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS Trading as Stiefel
Toctino is indicated for use in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids.
Patients in whom the eczema has predominantly hyperkeratotic features are more likely to respond to treatment than in those in whom the eczema predominantly presents as pompholyx (see section 5.1).
Toctino should only be prescribed by dermatologists, or physicians with experience in the use of systemic retinoids who have full understanding of the risks of systemic retinoid therapy and monitoring requirements. Prescriptions of Toctino for women of childbearing potential should be limited to 30 days of treatment and continuation of treatment requires a new prescription. Ideally, pregnancy testing, issuing a prescription and dispensing of Toctino should occur on the same day.
The recommended dose for Toctino is 10 mg or 30 mg once daily.
The recommended starting dose for Toctino is 30 mg once daily. A dose reduction to 10 mg once daily may be considered in patients with unacceptable adverse reactions to the 30 mg dose. In studies investigating 10 mg and 30 mg daily doses, both doses resulted in clearing of the disease. The 30 mg dose provided a more rapid response and a higher response rate. The 10 mg daily dose was associated with fewer adverse events (see section 5.1).
A treatment course of Toctino may be given for 12 to 24 weeks depending on response. Discontinuation of therapy is recommended in patients who have achieved clear or almost clear hands earlier than 24 weeks (see section 5.1). Discontinuation of therapy should also be considered for patients who still have severe disease after the initial 12 weeks of continuous treatment.
In the event of relapse, patients may benefit from further treatment courses of Toctino (see section 5.1).
The capsules should be taken with a main meal once daily, preferably at the same time each day (see section 5.2).
Toctino should not be prescribed if the patient’s eczema can be adequately controlled by standard measures, including skin protection, avoidance of allergens and irritants, and treatment with potent topical corticosteroids.
Toctino is not recommended for use in patients under 18 years of age.
Toctino is contraindicated in patients with severe or end stage renal impairment (see section 4.3).
Toctino is not recommended for use in patients with moderate renal impairment as there is insufficient data (see section 5.2).
No alteration of dosage or dosing frequency is required in patients with mild renal impairment (see section 5.2).
Toctino is contraindicated in patients with hepatic impairment (see section 4.3).
No alteration of dosage and dosing frequency is required in patients over 65 years (see section 5.2).
Alitretinoin is a derivative of vitamin A. Alitretinoin has been administered in oncological clinical studies at dosages of more than 10-times of the therapeutic dosage given for chronic hand eczema. The adverse effects observed were consistent with retinoid toxicity, and included severe headache, diarrhoea, facial flushing, hypertriglyceridemia. These effects were reversible.
3 years.
Do not store above 30°C. Store in the original package. Keep the blister in the outer carton in order to protect from light.
PVC/PE/PVDC/Aluminum blisters. Pack sizes of 30 capsules, soft.
Any unused medicinal product or waste material should be disposed in accordance with local requirements.
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