Generic Name and Formulations:
Mitotane 500mg; scored tabs.
Indications for LYSODREN:
Inoperable adrenal cortical carcinoma.
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.
Discontinue temporarily following 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. Pregnancy; avoid. Use effective contraception during and after discontinuation until mitotane levels are undetectable. Nursing mothers: not recommended.
Concomitant oral anticoagulants, CYP3A4 substrates; monitor for change in dose requirements.
Adrenal cytotoxic agent.
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.