Lysodren Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Lysodren Indications
Indications
Inoperable adrenocortical carcinoma.
Lysodren Dosage and Administration
Adult
Swallow whole. Take with food. 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
Lysodren Contraindications
Not Applicable
Lysodren Boxed Warnings
Boxed Warning
Adrenal crisis in the setting of shock, severe trauma, or infection.
Lysodren Warnings/Precautions
Warnings/Precautions
Risk for adrenal insufficiency and adrenal crisis. Temporarily withhold and give exogenous steroids until recovery during shock, trauma, infection, or adrenal suppression. Withhold treatment prior to planned surgeries. CNS toxicity (esp. mitotane levels >20mg/L). Monitor closely for infections, behavioral and neurologic assessments. Monitor mitotane plasma levels periodically (eg, monthly); consider monitoring levels every 2 weeks after starting treatment, dose adjustments, and regularly (every 2 months) after discontinuation. Evaluate thyroid function if cognitive dysfunction occurs. Ovarian macrocysts in premenopausal women. Perform pelvic ultrasound in premenopausal women at baseline and in regular intervals. Hepatotoxicity. Hematologic toxicity. Monitor LFTs, CBCs including neutrophils prior to initiation, at dose titration, and periodically during treatment. Platelet function disorders. Prolonged bleeding time. Perform ADP-inducted platelet aggregometry testing prior to surgery or dental procedures. Overweight or recent weight loss; monitor mitotane levels closely. Hepatic or renal impairment (mild or moderate): monitor closely and adjust dose; (severe): not recommended. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective nonhormonal contraception during and after discontinuation until mitotane levels are undetectable. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended.
Lysodren Pharmacokinetics
Elimination
Lysodren Interactions
Interactions
Avoid concomitant certain CYP3A4 substrates; if unavoidable, adjust substrate dosage. Avoid concomitant warfarin; if unavoidable, monitor INR frequently and adjust dose. Avoid concomitant hormonal contraceptives. May interfere with hormonal assays by increased plasma levels of hormone binding proteins (eg, sex hormone-binding globulin, corticosteroid-binding globulin).
Lysodren Adverse Reactions
Adverse Reactions
Anorexia, epigastric discomfort, nausea, vomiting, diarrhea, depression, dizziness, vertigo, rash, hypercholesterolemia, hypertriglyceridemia, hypothyroidism, decreased blood free testosterone in males.
Lysodren Clinical Trials
See Literature
Lysodren Note
Not Applicable
Lysodren Patient Counseling
See Literature