mitotane at a glance
Medicine class
Adrenal cytotoxic antineoplastic agent
Licensed role
Symptomatic treatment of advanced adrenocortical carcinoma
Monitoring
Specialist blood-level and safety monitoring is essential
Driving
Do not drive or operate machinery because impairment can be substantial
What is mitotane used for?
The selected UK product is licensed for:
Symptomatic treatment of advanced adrenocortical carcinoma that is unresectable, metastatic or has relapsed.
Its effect in non-functioning adrenocortical carcinoma has not been established.
How does mitotane work?
Mitotane selectively damages or suppresses adrenal-cortex cells and interferes with steroid-hormone production. Its precise biochemical mechanism remains uncertain; proposed effects include disruption of mitochondrial function and cholesterol handling, leading to adrenal-cell stress and death.
mitotane preparations and strengths
Tablet
Route: Oral
Strengths: 500 mg
How to take mitotane
Follow the specialist team's instructions. Practical administration points include:
Swallow the tablets with a glass of water during meals containing fat, which improves absorption.
Do not use tablets showing signs of deterioration.
Only the patient or caregiver should handle them; caregivers should wear disposable gloves, and pregnant people should not handle them.
Do not drive or operate machinery while taking mitotane.
mitotane side effects
Common or expected effects
- Nausea, vomiting, diarrhoea or abdominal discomfort
- Reduced appetite
- Sleepiness, fatigue or muscle weakness
- Dizziness, tingling, confusion or coordination problems
- Skin rash or inflammation of mucosal surfaces
- Raised cholesterol, triglycerides or liver enzymes
- Reduced white blood-cell count
- Adrenal insufficiency
Get urgent medical advice
- Symptoms of acute adrenal insufficiency, including marked weakness, vomiting, abdominal pain, confusion or fainting
- New or worsening problems with speech, memory, movement, balance or coordination
- Yellow skin or eyes, dark urine or severe itching suggesting liver injury
- Breathlessness, pronounced pallor, unusual bleeding or bruising suggesting a blood disorder
- Severe allergic reaction
mitotane in pregnancy
Mitotane is not recommended during pregnancy because limited human evidence suggests a risk of fetal adrenal abnormalities. Effective contraception is required during treatment and after stopping while mitotane remains detectable, which may take several months. Anyone who becomes pregnant or is planning pregnancy should contact the specialist team promptly.
mitotane while breastfeeding
Breastfeeding is contraindicated during treatment and after treatment while mitotane remains detectable in the blood, because it is likely to enter breast milk and could cause serious effects in the infant.
mitotane interactions
Mitotane has persistent enzyme-inducing effects, so the specialist or pharmacist should review all prescribed, non-prescribed and herbal products.
Spironolactone
Must not be combined with mitotane because it may block mitotane's action.
Warfarin and other coumarin anticoagulants
Mitotane accelerates their metabolism, so anticoagulant effect and requirements can change and need close monitoring.
CYP3A4 substrates, including sunitinib, etoposide and midazolam
Mitotane can alter their blood concentrations through enzyme induction, including after mitotane has been stopped.
Common questions about mitotane
Answers are fully visible for fast scanning and source review.
Why is mitotane prescribed for adrenal cancer?
It targets adrenal-cortex cells and is licensed to relieve symptoms of advanced adrenocortical carcinoma that cannot be removed, has spread or has returned.
Should mitotane be taken with food?
Yes. Swallow it with water during a meal containing fat because fat improves its absorption.
Why are blood tests needed with mitotane?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.