LYSODREN Rx

Indications for LYSODREN:

Inoperable adrenal cortical carcinoma.

Adult:

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:

Not established.

Warnings/Precautions:

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.

Interactions:

Concomitant oral anticoagulants, CYP3A4 substrates; monitor for change in dose requirements.

Pharmacological Class:

Adrenal cytotoxic agent.

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.

How Supplied:

Tabs—100