mitotane
Lysodren · ATC code L01XX23
Also known as: mitotan
- Key facts
- Active substance
- mitotane
- ATC code
- L01XX23
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Lysodren 500 mg tablets
- Marketing authorisation holder
- Esteve Pharmaceuticals, S.A.
- Information as of
- 2026-10-28
Key facts
Mitotane is an adrenolytic cytotoxic medicine. It is used for the symptomatic treatment of advanced adrenocortical carcinoma.
What it is used for
- Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenocortical carcinoma (Lysodren 500 mg tablets); its effect in non-functional carcinoma is not established.
Dosing
- Adults: start with 2-3 g per day and increase progressively (e.g. every two weeks) until plasma levels reach the therapeutic window of 14-20 mg/L.
- If Cushing's symptoms must be controlled urgently, starting doses of 4-6 g per day may be needed; a starting dose above 6 g/day is generally not recommended.
- Plasma levels above 20 mg/L may cause severe adverse effects (including neurotoxicity) and should not be exceeded; the target level is usually reached in 3 to 5 months.
- Check levels after each dose change and regularly (e.g. every two weeks, later monthly), also after interruption. Consider stopping if there is no clinical benefit after 3 months at the optimal dose.
- Fat-rich food increases absorption. For renal or hepatic impairment, see the full text.
Contraindications
- Hypersensitivity to the active substance or any of the excipients.
- Lactation.
- Concomitant use of spironolactone.
Important warnings
- Large metastatic masses should be surgically removed as far as possible before starting (risk of tumour infarction and haemorrhage).
- Adrenal insufficiency is frequent: steroid replacement may be needed; after shock, severe trauma or infection, stop mitotane temporarily and give steroids.
- Long-term high doses may cause reversible brain damage; regular neurological assessment, especially with levels above 20 mg/L.
- All blood cells can be affected (e.g. leukopenia, anaemia, thrombocytopenia).
- Because of storage in fat tissue, levels may stay elevated for weeks after stopping.
Side effects
- More than 80% of patients had at least one undesirable effect.
- These include adrenal insufficiency, nausea, vomiting, diarrhoea, epigastric discomfort, decreased appetite, hypercholesterolaemia, hypertriglyceridaemia, ataxia, paraesthesia, dizziness, somnolence, confusion, leukopenia, elevated liver enzymes, rash, gynaecomastia and asthenia.
Interactions
- Spironolactone may block the action of mitotane (contraindicated).
- Mitotane is an enzyme inducer: it accelerates metabolism of warfarin and CYP3A4 substrates (e.g. sunitinib, etoposide, midazolam); induction may persist after stopping.
- Caution with central nervous system depressants.
Pregnancy and breastfeeding
- Adrenal abnormalities have been seen in the foetus; not recommended in pregnancy or in women of childbearing potential not using contraception.
- Breast-feeding is contraindicated.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- LysodrenEsteve Pharmaceuticals, S.A. · EMEA/H/C/000521
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Lysodren
- Liechtenstein
- Lysodren
- Norway
- Lysodren
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
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Sources
- European Medicines Agency. Lysodren – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/lysodren-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.