Schedule H

Oral

• Soft gelatin capsules: 10 mg

• Soft gelatin capsules: 30 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Chronic Severe Refractory Hand Eczema (CHE)

Adults — Unresponsive to potent topical corticosteroids:

Parameter Dose

Starting dose 30 mg orally once daily with food

Titration Down-titrate to 10 mg once daily if dose-limiting adverse effects occur (headache, hyperlipidaemia, mucocutaneous dryness)

Usual maintenance dose 30 mg once daily

Maximum dose 30 mg/day

Duration: Up to 24 weeks; discontinue earlier if complete remission achieved.

Clinical notes:

• Must be prescribed and monitored by dermatologists only

• Exclude other causes of hand dermatitis (psoriasis, tinea manuum, contact dermatitis) before initiation

• Effective contraception mandatory in women of childbearing potential

• Response assessment typically at 12–24 weeks

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes Evidence Basis

Cutaneous T-cell Lymphoma 30 mg/day orally (continuous or intermittent) Variable based on response OFF-LABEL; Specialist only (Dermatology/Oncology) Phase II studies; not standard practice in India

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not applicable — Alitretinoin is not approved for use in patients below 18 years of age due to lack of safety and efficacy data.

Secondary Indications — Paediatrics (Off-label)

Not applicable — No established off-label paediatric indications.

Age restriction: Not recommended below 18 years of age. Use only under exceptional circumstances with specialist dermatologist supervision in patients approaching adulthood with severe refractory disease and no alternatives.

Severity Recommendation

Dialysis Avoid; no data available

• Pregnancy (highly teratogenic — all trimesters)

• Women of childbearing potential not using effective contraception (two reliable methods required)

• Breastfeeding

• Severe hepatic impairment

• Uncontrolled hyperlipidaemia (hypertriglyceridaemia or hypercholesterolaemia)

• Uncontrolled hypothyroidism

• Hypervitaminosis A

• Hypersensitivity to alitretinoin, other retinoids, or excipients (including soya or peanut allergy — capsules contain soya)

• Concurrent use with tetracyclines (risk of pseudotumour cerebri)

• Concurrent high-dose vitamin A supplementation

• Pre-existing hyperlipidaemia — optimise lipid levels before initiation

• History of depression or psychiatric disorders — monitor mood closely

• Thyroid dysfunction — may affect treatment response; optimise thyroid function

• Diabetes mellitus — may impair glucose tolerance

• Contact lens wearers — increased dry eye risk

• History of pancreatitis

• Concurrent phototherapy or significant sun exposure — increased photosensitivity

• Elderly patients with reduced hepatic or renal reserve

Parameter Recommendation

Risk category Contraindicated (Category X equivalent) — Highly teratogenic

Overall safety Causes severe fetal malformations (craniofacial, cardiac, CNS abnormalities); absolute contraindication

Contraception requirements Two reliable methods of contraception required: starting 1 month before treatment, throughout treatment, and for 1 month after discontinuation

Pregnancy testing Negative pregnancy test required before initiation; repeat monthly during treatment

Preferred alternatives Potent topical corticosteroids, tacrolimus ointment, or cyclosporine (under specialist supervision)

What to monitor Monthly pregnancy tests mandatory throughout treatment

Parameter Recommendation

Compatibility Contraindicated during breastfeeding

Drug levels in milk Expected to be excreted; potential for serious adverse effects in infant

Preferred alternatives Potent topical corticosteroids, topical calcineurin inhibitors

Resumption of breastfeeding Only after at least 1 month following complete drug discontinuation

• Starting dose: 10 mg once daily (lower end of dose range)

• Titration: Slower titration; assess tolerability before dose escalation to 30 mg

• Extra risks:

• Increased susceptibility to hyperlipidaemia

• Reduced hepatic and renal reserve — monitor function more frequently

• Fall risk from headache, dizziness, or visual disturbance

• Higher risk of mucocutaneous adverse effects

Drug/Class Interaction Recommendation

Tetracyclines (doxycycline, minocycline) Risk of pseudotumour cerebri (benign intracranial hypertension) Avoid combination — contraindicated

Vitamin A supplements or retinoid-containing products Additive hypervitaminosis A toxicity Avoid concurrent use

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin) May increase alitretinoin plasma levels Avoid or use with close monitoring

Progestogen-only contraceptives (minipills) Reduced contraceptive efficacy Do not rely solely on minipills; use two methods including barrier contraception

Drug/Class Interaction Recommendation

Statins Additive risk of myopathy; potential hepatotoxicity Monitor LFTs and lipid profile; may be needed to manage retinoid-induced hyperlipidaemia

Fibrates May be required for hypertriglyceridaemia management Monitor lipids and LFTs closely

Enzyme-inducing antiepileptics (carbamazepine, phenytoin, phenobarbital) CYP induction may reduce alitretinoin levels; may also reduce hormonal contraceptive efficacy Monitor efficacy; ensure adequate contraception

Oral anticoagulants (warfarin) Potential alteration in hepatic metabolism Monitor INR closely

• Headache (very common)

• Dry lips, cheilitis

• Dry skin, xerosis

• Dry eyes, conjunctivitis

• Flushing, erythema

• Hypertriglyceridaemia, hypercholesterolaemia

• Elevated transaminases (transient)

• Hair thinning, alopecia

• Arthralgia, myalgia

• Teratogenicity — Absolute contraindication in pregnancy; causes severe fetal malformations

• Benign intracranial hypertension (pseudotumour cerebri) — Presents with persistent headache, visual disturbances, papilloedema; requires immediate discontinuation

• Depression, suicidal ideation — Monitor mood; discontinue if significant psychiatric symptoms develop

• Hepatotoxicity — Marked liver enzyme elevation; requires dose reduction or discontinuation

• Pancreatitis — Secondary to severe hypertriglyceridaemia; discontinue immediately

• Severe hyperlipidaemia — Triglycerides >800 mg/dL associated with pancreatitis risk

Phase Parameters

Baseline Pregnancy test (women of childbearing potential — must be negative); LFTs; Fasting lipid profile; Thyroid function tests; Renal function; CBC; Psychiatric history assessment

After initiation Lipid profile and LFTs: Every 4 weeks; Pregnancy test: Monthly (women); Clinical assessment for headache and visual symptoms at each visit

Long-term Lipid profile and LFTs: Monthly throughout treatment duration; Periodic mental health assessment; Ophthalmological evaluation if visual symptoms or persistent headache

• Toctino® (Galderma)

• Alitrex® (Sun Pharma)

• Aletro® (Torrent)

• Handvate® (Indoco)

Note: Not included in NLEM; not under NPPA price control. Available via private retail; typically restricted to dermatology prescription.

• Prefer 30 mg daily as initial dose for optimal efficacy — reduce to 10 mg only if adverse effects are dose-limiting

• Structured contraception counselling and documentation is mandatory before prescribing to women of childbearing potential

• Therapeutic effect typically seen after 4–8 weeks — reassess at 12 weeks if no improvement; do not discontinue prematurely

• Differentiate chronic hand eczema from palmoplantar psoriasis, tinea manuum, and contact dermatitis before initiating therapy

• Counsel patients on skin hydration and lip care (emollients, lip balm) to manage mucocutaneous dryness

• Lipid abnormalities are common — baseline optimisation and ongoing monitoring essential; may require lipid-lowering therapy during treatment

alitretinoin; hand eczema; retinoid; dermatology; teratogenic; pregnancy-contraindicated; hyperlipidaemia; Schedule H; specialist-only; NLEM-excluded

RxIndia v1.0 — 09 Apr 2025

• CDSCO approved product inserts

• AIIMS Dermatology protocols

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Indian Journal of Dermatology, Venereology and Leprology (clinical practice reviews)

• Prescribing information from marketed Indian brands

• European RCTs (for off-label cutaneous T-cell lymphoma indication — marked accordingly)