Mitotane
- Atc Codes:L01XX23
- CAS Codes:53-19-0
- PHARMGKB ID:53-19-0
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Unlabeled Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Drug Interactions
- Nutrition/Nutraceutical Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Lysodren; Belgium: Lysodren; Bulgaria: Lysodren; Cyprus: Lysodren; Czech Republic: Lysodren; Denmark: Lysodren; Estonia: Lysodren; Finland: Lysodren; France: Lysodren; Germany: Lysodren; Greece: Lysodren; Hungary: Lysodren; Ireland: Lysodren; Italy: Lysodren; Latvia: Lysodren; Lithuania: Lysodren; Luxembourg: Lysodren; Malta: Lysodren; Netherlands: Lysodren; Poland: Lysodren; Portugal: Lysodren; Romania: Lysodren; Slovakia: Lysodren; Slovenia: Lysodren; Spain: Lysodren; Sweden: Lysodren; UK: Lysodren.
North America
Canada: Lysodren; USA: Lysodren.
Latin America
Brazil: Lisodren.
Asia
Japan: Opeprim.
Drug combinations
Chemistry
Mitotane: C~14~H~10~Cl~4~. Mw: 320.04. (1) Benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]-, (±)-; (2)(±)-1,1-Dichloro-2-(o-chlorophenyl)-2-(p-chlorophenyl)ethane. CAS-53-19-0 (1968).
Pharmacologic Category
Other Antineoplastic Agents. (ATC-Code: L01XX23).
Mechanism of action
Causes adrenal cortical atrophy. Affects mitochondria in adrenal cortical cells and decreases production of cortisol. Also alters peripheral metabolism of steroids.
Therapeutic use
Treatment of adrenocortical carcinoma.
Pregnancy and lactiation implications
There are as yet no adequate, well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Not recommended during lactation.
Unlabeled use
Treatment of Cushing’s syndrome.
Contraindications
Hypersensitivity to mitotane or any component of the formulation.
Warnings and precautions
Hazardous agent. Acute adrenal insufficiency may occur in face of shock, trauma, or infection. Neurotoxicity might occur with long-term (>2 years) use. Use with caution in hepatic impairment (metabolism may be decreased). Tumor tissues should be removed from metastatic masses prior to initiation of treatment (rapid cytotoxic effect may cause tumor hemorrhage). Steroid replacement with glucocorticoid, sometimes mineralocorticoid, necessary.