Drug Action
Acitretin is a metabolite of etretinate.
PDF page 1349
Drug reference
Acitretin is a metabolite of etretinate.
PDF page 1349
Severe extensive psoriasis resistant to other forms of therapy (under expert supervision) | Palmoplantar pustular psoriasis (under expert supervision) | Severe congenital ichthyosis (under expert supervision) ▶BY MOUTH ▶Adult: Initially 25–30 mg daily for 2–4 weeks, then adjusted according to response to 25–50 mg daily, increased to up to 75 mg daily, dose only increased to 75 mg daily for short periods in psoriasis Severe Darier’s disease (keratosis follicularis) (under expert supervision) ▶BY MOUTH ▶Adult: Initially 10 mg daily for 2–4 weeks, then adjusted according to response to 25–50 mg daily
PDF page 1349
Hyperlipidaemia
PDF page 1350
Avoid excessive exposure to sunlight and unsupervised use of sunlamps. diabetes (can alter glucose tolerance—initial frequent blood glucose checks). do not donate blood during and for 3 years after stopping therapy (teratogenic risk). history of depression (risk of neuropsychiatric reactions). in children use only in Skin exceptional circumstances and monitor growth parameters and bone development (premature epiphyseal closure reported). investigate atypical musculoskeletal symptoms
PDF page 1350
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. Each prescription for oral acitretin 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.
PDF page 1350
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.
PDF pages 1349, 1350
→Appendix 1: retinoids
PDF page 1350
▶Common or very common Abdominal pain. arthralgia. brittle nails. conjunctivitis. diarrhoea. dry mouth. gastrointestinal disorder. haemorrhage. hair texture abnormal. headache. increased risk of infection. mucosal abnormalities. myalgia. nausea. oral disorders. peripheral oedema. skin reactions. thirst. vomiting. xerophthalmia ▶Uncommon Dizziness. hepatic disorders. photosensitivity reaction. vision disorders ▶Rare or very rare Bone pain. exostosis. idiopathic intracranial hypertension. peripheral neuropathy ▶Frequency not known Angioedema. capillary leak syndrome. drowsiness. dysphonia. flushing. glucose tolerance impaired. granuloma. hearing impairment. hyperhidrosis. malaise. pyogenic granuloma. retinoic acid syndrome. taste altered. tinnitus SIDE-EFFECTS, FURTHER INFORMATION Exostosis Skeletal hyperostosis and extra-osseous calcification reported following long-term treatment with etretinate (of which acitretin is a metabolite) and premature epiphyseal closure in children. Benign intracranial hypertension Discontinue if severe headache, nausea, vomiting, or visual disturbances occur.
PDF page 1350
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 (including those with a history of infertility), exclude pregnancy up to 3 days before treatment, every month during treatment, and every 1–3 months for 3 years after stopping treatment. Treatment should be started on day 2 or 3 of menstrual cycle. Females of childbearing age must practise effective contraception for at least 1 month before starting treatment, during treatment, and for at least 3 years after stopping treatment. Females 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 seek medical attention immediately if they become pregnant during treatment or within 3 years of stopping treatment. They should also be advised to avoid alcohol during treatment and for 2 months after stopping treatment.
PDF page 1350
Manufacturer advises avoid—teratogenic.
PDF page 1350
Avoid.
PDF page 1350
Manufacturer advises avoid in severe impairment.
PDF page 1350
Avoid in severe impairment; increased risk of toxicity.
PDF page 1350
▶Monitor serum-triglyceride and serum-cholesterol concentrations before treatment, 1 month after starting, then every 3 months. ▶Check liver function at start, then every 2–4 weeks for first 2 months and then every 3 months.
PDF page 1350
There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension, oral solution Capsule CAUTIONARY AND ADVISORY LABELS 10, 11, 21 ▶Acitretin (Non-proprietary) Acitretin 10 mg Acitretin 10mg capsules | 60 capsule P £26.98 DT = £26.98 Acitretin 25 mg Acitretin 25mg capsules | 60 capsule P £55.24 DT = £43.75 ▶Neotigason (Teva UK Ltd) Acitretin 10 mg Neotigason 10mg capsules | 60 capsule P £17.30 DT = £26.98 Acitretin 25 mg Neotigason 25mg capsules | 60 capsule P £43.00 DT = £43.75
PDF page 1350
Risk of neuropsychiatric reactions The MHRA advises patients and carers to seek medical attention if changes in mood or behaviour occur. Pregnancy Prevention Programme Pharmacists must ensure that female patients have a patient card—see also Important safety information.
PDF page 1350
Initially 25–30 mg daily for 2–4 weeks, then
First-line fragment. Read the complete Indications and Dose section above.
PDF page 1349
Initially 10 mg daily for 2–4 weeks, then
First-line fragment. Read the complete Indications and Dose section above.
PDF page 1349