9-cis Retinoic Acid (Pan-Retinoic Acid Receptor Agonist) Pregnancy: Absolute contraindication in pregnancy — alitretinoin is a powerful human teratogen inducing a high frequency of severe and life-threatening birth defects, with an increased incidence of spontaneous abortion; contraindicated in nursing mothers. Women of childbearing potential must meet all conditions of the Pregnancy Prevention Programme: effective contraception without interruption from 1 month before starting, throughout treatment and for 1 month after the end of treatment, with pregnancy testing before, ideally monthly during, and 1 month after stopping treatment.

Alitretinoin

Brand names: Toctino

Alitretinoin is an oral retinoid (9-cis-retinoic acid) licensed for severe chronic hand eczema unresponsive to potent topical corticosteroids.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 30 mg once daily (recommended starting dose); a dose reduction to 10 mg once daily may be considered in patients with unacceptable adverse reactions to the 30 mg dose

Route: Oral — 10 mg soft capsules, taken with a main meal

Frequency: Once daily, preferably at the same time each day

Max: 30 mg once daily — SPC §4.2: 'The recommended dose for alitretinoin is 10 mg or 30 mg once daily'

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.

Dose adjustments

Renal

Contraindicated in patients with severe or end stage renal impairment; not recommended in moderate renal impairment as there is insufficient data; no alteration of dosage or dosing frequency is required in mild renal impairment.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Pregnancy — an absolute contraindication
Women of childbearing potential unless all conditions of the Pregnancy Prevention Programme are met
Nursing mothers (breast-feeding)
Hepatic insufficiency
Severe renal insufficiency
Uncontrolled hypercholesterolaemia
Uncontrolled hypertriglyceridaemia
Uncontrolled hypothyroidism
Hypervitaminosis A
Hypersensitivity to alitretinoin, to other retinoids or to any excipient — the capsules contain soya oil, so patients allergic to peanut or soya should not take this medicine
Concomitant treatment with tetracyclines

Side effects

Headache (30 mg: 23.9%; 10 mg: 10.8%)
Increased triglycerides (30 mg: 35.4%; 10 mg: 17.0%) and increased cholesterol (30 mg: 27.8%; 10 mg: 16.7%)
Decreased TSH (30 mg: 8.4%; 10 mg: 6.0%) and decreased free T4 (30 mg: 10.5%; 10 mg: 2.9%)
Erythema (30 mg: 5.5%; 10 mg: 1.7%); dry skin, dry lips, cheilitis, alopecia
Flushing (30 mg: 5.9%; 10 mg: 1.6%) and hypertension
Nausea (30 mg: 5.1%; 10 mg: 2.4%), dry mouth, vomiting
Psychiatric: depression, mood alterations, anxiety; suicide, suicide attempt and suicidal ideation reported

Interactions

Tetracyclines — concomitant treatment is contraindicated (SPC §4.3, cross-referencing §4.5). NOTE: the full §4.5 interactions section was not captured in the source bundle, so this list is incomplete

Clinical monograph

How it works

It activates both retinoic acid and retinoid X nuclear receptors, producing anti-inflammatory and immunomodulatory effects in the skin.

Prescribing in practice

It is highly teratogenic, so women of childbearing potential must be enrolled in a pregnancy prevention programme with effective contraception and pregnancy testing.
It can raise serum lipids and may cause headache and reduced thyroid function, with hepatic effects also reported.
Initiate and supervise treatment under specialist dermatology care.

Monitoring

Monitor pregnancy status, fasting lipids, liver function and thyroid function before and during treatment.

Counselling the patient

Pregnancy must be avoided during treatment and for the specified period afterwards; do not donate blood while taking it.
Report severe or persistent headache, visual disturbance, or mood changes promptly.
Headache and flushing are recognised effects, particularly early in treatment.

Evidence & guidelines

Alitretinoin is recommended by NICE as an option for severe chronic hand eczema refractory to potent topical corticosteroids.

Reference: BACH trial (Ruzicka et al. NEJM 2004); NICE TA177; MHRA SPC Toctino; BAD Chronic Hand Eczema Guideline (2022); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways