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Lysodren
Mitotane
$2904.00
500mg · 3 × 100 tablets · 3 months supply
BrandBranded medicine· By C.T.S
$968.00 per month
How long a supply?
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Annual cost
$10648a year at this pack size
Prescription required
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FDA boxed warningAdrenal crisis in the setting of shock, severe trauma or infection
Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death.
If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs.
About Lysodren
Overview
Lysodren (mitotane) is a prescription medicine supplied as tablets. It is used to treat adrenocortical carcinoma, a cancer of the outer layer of the adrenal gland, that cannot be treated with surgery, whether or not the cancer produces hormones. Mitotane suppresses this outer layer and changes how the body processes steroid hormones, although its exact mechanism of action is unknown.
What it treats
- Inoperable adrenocortical carcinoma (cancer of the adrenal cortex), whether hormone-producing (functional) or non-hormone-producing (nonfunctional).
Safety information
Side effects
Common side effects include loss of appetite, upper abdominal discomfort, nausea, vomiting, diarrhea, dizziness, a spinning sensation (vertigo), rash, high cholesterol or triglyceride levels, an underactive thyroid, and reduced free testosterone levels in males. Serious side effects include adrenal insufficiency and adrenal crisis, nervous system toxicity, large ovarian cysts in premenopausal women, liver toxicity, blood disorders, and prolonged bleeding time. Contact a doctor promptly if you experience changes in behavior or nervous system symptoms, unusual bleeding, or other suspected serious side effects. Do not drive or operate hazardous machinery if you have nervous system side effects. Contact your doctor promptly if you develop an infection, experience shock or a serious injury, or have adrenal insufficiency. The label advises temporarily withholding Lysodren in these situations; steroid replacement may be needed. Tell your doctor if surgery is planned because Lysodren can prolong bleeding time. Lysodren can harm an unborn baby. Use effective nonhormonal contraception if you could become pregnant, and contact your doctor if pregnancy occurs. Regular monitoring may include mitotane blood levels, liver function, blood counts, behavioral and neurological assessments, and pelvic ultrasound in premenopausal women.
FDA boxed warning
Adrenal crisis in the setting of shock, severe trauma or infection
Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death.
If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The label lists no formal contraindications. However, Lysodren is not recommended for people with severe liver or kidney impairment. Mild to moderate liver or kidney impairment requires frequent monitoring of mitotane blood levels and possible treatment adjustment. Treatment should be temporarily withheld during shock, trauma, infection or adrenal insufficiency. Steroid replacement may be needed because of the risk of adrenal insufficiency and adrenal crisis. Other conditions requiring caution include: - Nervous system effects: regular checks of behaviour, nervous system function and mitotane blood levels are needed. Do not drive or operate hazardous machinery if these effects occur. - Large ovarian cysts in premenopausal women: pelvic ultrasound monitoring is needed before and during treatment. - Liver toxicity and effects on blood cells: liver function tests and complete blood counts are needed before and during treatment. - Prolonged bleeding time: this risk should be considered when surgery is planned. Lysodren can harm an unborn baby. Women who could become pregnant should use effective nonhormonal contraception. Do not breastfeed during treatment.
Interactions
Avoid taking Lysodren with spironolactone, hormonal contraceptives, warfarin or certain medicines processed by the enzyme CYP3A. If you use any of these, discuss them with your doctor, who can check which medicines need to be avoided.
Using Lysodren
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label LYSODREN (MITOTANE) TABLET [ESTEVE PHARMACEUTICALS, S.A.] (DailyMed, retrieved 19 September 2026).
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