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9-cis Retinoic Acid (Pan-Retinoic Acid Receptor Agonist) Pregnancy: CONTRAINDICATED — teratogenic; mandatory Pregnancy Prevention Programme; effective contraception ×4 weeks before, during, and ×4 weeks after treatment

Alitretinoin

Brand names: Toctino

Adult dose

Dose: 30 mg once daily with main meal; reduce to 10 mg if not tolerated
Route: Oral
Frequency: Once daily (with food)
Max: 30 mg/day; maximum 24-week treatment course
Severe chronic hand eczema (CHE) refractory to potent topical corticosteroids; reassess response at 12 weeks — continue only if clear/almost clear; maximum 24 weeks per course

Paediatric dose

Dose: Not established N/A/kg
Route: N/A
Frequency: N/A
Max: N/A
Not licensed in paediatrics

Dose adjustments

Renal

No dose adjustment required

Hepatic

Contraindicated in severe hepatic impairment

Paediatric weight-based calculator

Not licensed in paediatrics

Clinical pearls

  • BACH trial (Ruzicka et al. NEJM 2004): alitretinoin 30 mg achieved clear/almost clear hands in 48% vs 17% placebo in severe CHE — NICE TA177 approved; significant improvement in a condition with high occupational impact and treatment-refractory course
  • Pregnancy Prevention Programme (PPP) is mandatory — same stringent requirement as isotretinoin: negative pregnancy test before prescribing, monthly tests during, contraception ×4 weeks before, during, and ×4 weeks after; prescriber and pharmacist registration required
  • Alitretinoin vs isotretinoin for CHE: alitretinoin (9-cis RA) is specifically licensed for CHE; isotretinoin (13-cis RA) is used for acne; distinct retinoid receptor binding profiles; for severe CHE, alitretinoin is preferred and NICE-approved
  • Headache: most common side effect — frequently benign and self-limiting; if associated with visual disturbance or papilloedema, stop immediately and refer for raised intracranial pressure assessment (particularly if on tetracycline concurrently)
  • Occupational chronic hand eczema: nurses, hairdressers, food handlers most commonly affected — successful treatment of severe CHE reduces sick leave and occupational disability; should be used alongside allergen/irritant avoidance

Contraindications

  • Pregnancy (teratogenic — Pregnancy Prevention Programme mandatory)
  • Breastfeeding
  • Severe hepatic impairment
  • Severely elevated lipids
  • Vitamin A supplementation concurrently
  • Hypersensitivity to retinoids

Side effects

  • Headache (most common)
  • Mucocutaneous dryness (lips, skin, eyes)
  • Hyperlipidaemia (triglycerides > cholesterol)
  • Elevated transaminases
  • Teratogenicity
  • Arthralgia
  • Flushing

Interactions

  • Vitamin A supplements — additive toxicity; avoid
  • Tetracyclines — combined with retinoids, risk of benign intracranial hypertension; avoid combination
  • Methotrexate — additive hepatotoxicity

Monitoring

  • Pregnancy test (monthly)
  • Lipid profile (before, at 4 weeks, then every 8 weeks)
  • LFTs (before, at 4 weeks, then every 8 weeks)
  • Response assessment at 12 weeks (continue only if clear/almost clear)

Reference: BNFc; BNF 90; BACH trial (Ruzicka et al. NEJM 2004); NICE TA177; MHRA SPC Toctino; BAD Chronic Hand Eczema Guideline (2022). Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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