Lysodren Generic Name & Formulations
Mitotane 500mg; scored tabs.
Adrenal cytotoxic agent.
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.
Lysodren Boxed Warnings
Adrenal crisis in the setting of shock or severe trauma.
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.
Avoid concomitant certain CYP3A4 substrates; increase substrate dosage if unavoidable. Concomitant warfarin; monitor coagulation tests and adjust dose.
Lysodren 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
Lysodren Patient Counseling