Loading
A relative of the insecticide DDT that is the only drug specific to adrenal cortex cancer; it needs blood-level monitoring and permanent steroid replacement.
Approved 1970. Adjuvant use for high-risk resected ACC (Terzolo 2007; ADIUVO 2023 negative for low risk), monotherapy for indolent advanced disease, and combined with EDP chemotherapy (FIRM-ACT). Therapeutic range 14-20 mg/L; toxicities include neurologic effects, GI intolerance, adrenal insufficiency (hydrocortisone replacement at higher doses), CYP3A4 induction affecting other drugs.
Metabolised in adrenocortical cells to an acyl chloride that binds mitochondrial proteins and inhibits steroidogenesis (SOAT1 inhibition causes ER stress); cytotoxic to adrenocortical tissue.
1.Mitotane acts on its target, the hormone receptor or the enzyme that makes the hormone.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. Adrenocortical carcinoma is rare enough that most plans cover on diagnosis.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE search: mitotane. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
| Region | Year | Indication |
|---|---|---|
| US | 1970 | Inoperable adrenocortical carcinoma (functional and non-functional) |
| EU | 2004 | Advanced adrenocortical carcinoma |
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Adjuvant mitotane may be withheld in low-grade localised adrenocortical carcinoma, given the good prognosis and the drug's toxicity.
The standard-of-care rows on both adrenocortical carcinoma pages, from who gets mitotane after surgery to the EDP-M regimen, follow this guideline.
EDP-mitotane is the first-line chemotherapy for adrenocortical carcinoma that cannot be removed, and the comparator arm for new trials; outcomes remain poor and better drugs are needed.
Query for this drug: (TITLE:"Mitotane" OR ABSTRACT:"Mitotane" OR TITLE:"Lysodren" OR ABSTRACT:"Lysodren") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Mitotane, not a curated reading list.
Shares Advanced and metastatic adrenocortical carcinoma (ENSAT stage IV or unresectable), Adrenocortical carcinoma, Cytotoxic chemotherapy.
Shares Adrenalectomy, Advanced and metastatic adrenocortical carcinoma (ENSAT stage IV or unresectable), Cytotoxic chemotherapy.
Shares Adrenalectomy, Localised adrenocortical carcinoma (ENSAT stage I to III, resectable).