• Pancreatic, thyroid, and other endocrine cancers

Lysodren Generic Name & Formulations

General Description

Mitotane 500mg; scored tabs.

Pharmacological Class

Adrenal cytotoxic agent.

How Supplied



Generic Availability


Lysodren Indications


Inoperable adrenal cortical carcinoma.

Lysodren Dosage and Administration


2–6g/day in divided doses (3–4 times/day). Doses may be increased incrementally to achieve a blood concentration of 14–20mg/L, or as tolerated. Dose modifications: see full labeling.


Not established.

Lysodren Contraindications

Not Applicable

Lysodren Boxed Warnings

Boxed Warning

Adrenal crisis in the setting of shock or severe trauma.

Lysodren Warnings/Precautions


Discontinue until recovery if adrenal crisis occurs in shock or severe trauma. CNS toxicity (esp. with high doses). Adrenal insufficiency: give steroid replacement as clinically indicated; measure free cortisol and ACTH levels. Ovarian macrocysts in premenopausal women. Hepatic impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and after discontinuation until mitotane levels are undetectable. Pregnancy: avoid. Nursing mothers: not recommended.

Lysodren Pharmacokinetics

See Literature

Lysodren Interactions


Avoid concomitant certain CYP3A4 substrates; increase substrate dosage if unavoidable. Concomitant warfarin; monitor coagulation tests and adjust dose.

Lysodren Adverse Reactions

Adverse Reactions

Anorexia, nausea, vomiting, diarrhea, depression, dizziness, vertigo, rash, neutropenia, growth retardation, hypothyroidism, confusion, headache, ataxia, mental impairment, weakness, dysarthria, maculopathy, hepatitis, elevated liver enzymes, gynecomastia, hypercholesterolemia, hypertriglyceridemia.

Lysodren Clinical Trials

See Literature

Lysodren Note

Not Applicable

Lysodren Patient Counseling

See Literature