Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Lysodren Generic Name & Formulations
Legal Class
Rx
General Description
Mitotane 500mg; scored tabs.
Pharmacological Class
Adrenal cytotoxic agent.
How Supplied
Tabs—100
Manufacturer
Generic Availability
NO
Lysodren Indications
Indications
Inoperable adrenal cortical carcinoma.
Lysodren Dosage and Administration
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.
Lysodren Contraindications
Not Applicable
Lysodren Boxed Warnings
Boxed Warning
Adrenal crisis in the setting of shock or severe trauma.
Lysodren Warnings/Precautions
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
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
