Pancreatic, thyroid, and other endocrine cancers:

Indications for: LYSODREN

Inoperable adrenal cortical carcinoma.

Adult Dosage:

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.

Children Dosage:

Not established.

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 Classification:

Adrenal cytotoxic agent.

LYSODREN Interactions:

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

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.

Generic Drug Availability:


How Supplied: