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Indication and Important Safety Information

LYSODREN® is an adrenal cytotoxic agent indicated for the treatment of inoperable, functional or nonfunctional, adrenal cortical carcinoma.

Warning/Adrenal crisis in the setting of shock or severe trauma:  In patients taking LYSODREN®, adrenal crisis occurs in the setting of shock or severe trauma and response to shock is impaired. Administer hydrocortisone, monitor for escalating signs of shock and discontinue LYSODREN® until recovery.

CNS Toxicity: CNS toxicity, including sedation, lethargy, and vertigo, occurs with LYSODREN® treatment. Mitotane plasma concentrations exceeding 20 mcg/mL are associated with a greater incidence of toxicity.
Adrenal Insufficiency: Treatment with LYSODREN® can cause adrenal insufficiency. Institute steroid replacement as clinically indicated.

Measure free cortisol and corticotropin (ACTH) levels to achieve optimal steroid replacement.
Embryo-Fetal Toxicity: LYSODREN® can cause fetal harm when administered to a pregnant woman. Abnormal pregnancy outcomes, such as preterm births and early pregnancy loss, can occur in patients exposed to mitotane during pregnancy. Advise females of reproductive potential to use effective contraception during treatment with LYSODREN® and after discontinuation of treatment for as long as mitotane plasma levels are detectable.
Ovarian Macrocysts in Premenopausal Women: Ovarian macrocysts, often bilateral and multiple, have been reported in premenopausal patients receiving LYSODREN®. Complications from these cysts, including adnexal torsion and hemorrhagic cyst rupture, have been reported. In some cases, improvement after mitotane discontinuation has been described.
Lactation: Mitotane is excreted in human milk; however, the effect of LYSODREN® on the breastfed infant, or effect on milk production is unknown.

Because of the potential for serious adverse reactions in the breastfed infant, advise nursing women that breastfeeding is not recommended during treatment with LYSODREN® and after discontinuation of treatment for as long as mitotane plasma levels are detectable.
Hepatic Impairment: Administer LYSODREN® with caution to patients with hepatic impairment.

Common adverse reactions (³15%) include: anorexia, nausea, vomiting and diarrhea; depression, dizziness or vertigo; and rash. LYSODREN® is a cytotoxic drug. Follow applicable special handling and disposal procedures.

Please see full Prescribing Information, including BOXED WARNING, for LYSODREN® (mitotane) tablets.

To report SUSPECTED ADVERSE REACTIONS, contact Direct Success Pharmacy, Inc. at 1-844-LYSODREN (1-844-597-6373) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Last updated: June 2019; LYS – WEB – 0619 – US