Drug reference
Severe chronic hand eczema refractory to potent topical corticosteroids ▶BY MOUTH ▶Adult (prescribed by or under supervision of a consultant dermatologist): 30 mg once daily; reduced if not tolerated to 10 mg once daily for 12–24 weeks total duration of treatment, discontinue if no response after 12 weeks, course may be repeated in those who relapse
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DUE TO INTERACTIONS ▶Manufacturer advises reduce dose to 10 mg once daily with concurrent use of potent inhibitors of CYP3A4, CYP2C8 and moderate inhibitors of CYP2C9.
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Hypervitaminosis A. uncontrolled hyperlipidaemia. uncontrolled hypothyroidism
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Avoid blood donation during treatment and for at least 1 month after stopping treatment. dry eye syndrome. history of depression (risk of neuropsychiatric reactions)
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Prescribing for females of childbearing potential The Pregnancy Prevention Programme is supported by the following materials provided by the manufacturer: Checklists for prescribers and pharmacists, and Patient reminder cards. Skin Each prescription for oral alitretinoin should be limited to a supply of up to 30 days’ treatment. Pregnancy testing should ideally be carried out on the same day as prescription issuing and dispensing.
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NICE decisions ▶Alitretinoin for the treatment of severe chronic hand eczema (August 2009) NICE TA177 Alitretinoin (Toctino ®) is recommended for the treatment of severe chronic hand eczema in adults that has not responded to potent topical corticosteroids. Treatment should be stopped as soon as an adequate response has been achieved (hands clear or almost clear), or if the eczema remains severe after 12 weeks, or if an adequate response has not been achieved by 24 weeks. www.nice.org.uk/guidance/ta177
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MHRA/CHM ADVICE: ORAL RETINOID MEDICINES: REVISED AND SIMPLIFIED PREGNANCY PREVENTION EDUCATIONAL MATERIALS FOR HEALTHCARE PROFESSIONALS AND WOMEN (JUNE 2019) New prescriber checklists, patient reminder cards, and pharmacy checklists are available to support the Pregnancy Prevention Programme in women and girls of childbearing potential taking oral acitretin, alitretinoin, or isotretinoin. Healthcare professionals are reminded that the use of oral retinoids is contra-indicated in pregnancy due to a high risk of serious congenital malformations, and any use in females must be within the conditions of the Pregnancy Prevention Programme (see Conception and contraception and Prescribing and dispensing information). Neuropsychiatric reactions have been reported in patients taking oral retinoids. Healthcare professionals are advised to monitor patients for signs of depression or suicidal ideation and refer for appropriate treatment, if necessary; particular care is needed in those with a history of depression. Patients should be advised to speak to their doctor if they experience any changes in mood or behaviour, and encouraged to ask family and friends to look out for any change in mood.
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→Appendix 1: retinoids
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▶Common or very common Alopecia. anaemia. conjunctivitis. dizziness. dry eye. dry mouth. eye irritation. fatigue. flushing. headache. hypercholesterolaemia. hypertension. hypertriglyceridaemia (risk of pancreatitis if triglycerides above 9 mmol/litre). joint disorders. myalgia. nausea. oral disorders. skin reactions. tinnitus. vomiting ▶Uncommon Bone disorders. cataract. dyspepsia. epistaxis . vision disorders ▶Rare or very rare Anxiety. behaviour abnormal. depression. hair texture abnormal. idiopathic intracranial hypertension. mood altered. nail disorder. photosensitivity reaction. psychotic disorder. suicidal tendencies. vasculitis ▶Frequency not known Inflammatory bowel disease. peripheral oedema SIDE-EFFECTS, FURTHER INFORMATION Dry eyes may respond to lubricating eye ointment or tear replacement therapy. Discontinue treatment if signs or symptoms of idiopathic intracranial hypertension such as headache, nausea, vomiting, papilloedema, or visual disturbances occur. Risk of pancreatitis if triglycerides above 9 mmol/litre— discontinue if uncontrolled hypertriglyceridaemia or pancreatitis.
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The MHRA advises that women and girls of childbearing potential being treated with the oral retinoids acitretin, alitretinoin, or isotretinoin must be supported on a Pregnancy Prevention Programme with regular follow-up and pregnancy testing. Pregnancy prevention Effective contraception must be used. In females of childbearing potential, exclude pregnancy a few days before treatment, every month during treatment (unless there are compelling reasons to indicate that there is no risk of pregnancy), and 4 weeks after stopping treatment. Females must practise effective contraception for at least 1 month before starting treatment, during treatment, and for at least 1 month after stopping treatment. They should be advised to use at least 1 method of contraception but ideally they should use 2 methods of contraception. Oral progestogen-only contraceptives are not considered effective. Barrier methods should not be used alone but can be used in conjunction with other contraceptive methods. Females should be advised to discontinue treatment and to seek prompt medical attention if they become pregnant during treatment or within 1 month of stopping treatment.
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Manufacturer advises avoid—teratogenic.
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Manufacturer advises avoid.
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Manufacturer advises avoid— limited information available.
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Manufacturer advises avoid in severe impairment—no information available.
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Monitor serum lipids (more frequently in those with diabetes, history of hyperlipidaemia, or risk factors for cardiovascular disease)—discontinue if uncontrolled hyperlipidaemia.
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There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 10, 11, 21 EXCIPIENTS: May contain Sorbitol ▶Alitretinoin (Non-proprietary) Alitretinoin 10 mg Alitretinoin 10mg capsules | 30 capsule P £493.72 DT = £493.72 Alitretinoin 30 mg Alitretinoin 30mg capsules | 30 capsule P £493.72 DT = £493.72 ▶Toctino (Stiefel Laboratories (UK) Ltd) Alitretinoin 10 mg Toctino 10mg capsules | 30 capsule P £493.72 DT = £493.72 Alitretinoin 30 mg Toctino 30mg capsules | 30 capsule P £493.72 DT = £493.72
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Risk of neuropsychiatric reactions The MHRA advises patients and carers to seek medical attention if changes in mood or behaviour occur. UV light Manufacturer advises patients to avoid excessive exposure to UV light (including sunlight, solariums)— sunscreen with a high protection factor should be applied. Pregnancy Prevention Programme Pharmacists must ensure that female patients have a patient card—see also Important safety information.
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