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U.S. Department of Health and Human Services

Safety

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Lysodren (Mitotane) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

November 2013

Summary View

WARNINGS

  • Literature reports suggest that mitotane plasma concentrations exceeding 20 mcg/mL are associated with a greater incidence of high grade central nervous system toxicity.
  • Since Lysodren increases hormone binding proteins, measurement of free cortisol and corticotropin (ACTH) levels may be useful in achieving optimal steroid replacement.

PRECAUTIONS

General
  • Prolonged bleeding time has been reported in patients treated with Lysodren. Consider this possibility prior to any surgical intervention.
Drug Interactions
  • Lysodren is a strong inducer of cytochrome P-450 3A4 (CYP3A4). Monitor patients for a change in dosage requirements for the concomitant drug when administering Lysodren to patients receiving drugs that are substrates of CYP3A4…
Pregnancy – Pregnancy Category D
  • Lysodren can cause fetal harm when administered to a pregnant woman…
Nursing Mothers
  • Mitotane has been detected in breast milk. Because of the potential for serious adverse reactions in nursing infants from mitotane, advise women to discontinue nursing during Lysodren therapy and after treatment discontinuation for as long as mitotane plasma levels are detectable.

ADVERSE REACTIONS

  • Infrequently occurring side effects involve the eye (visual blurring, diplopia, lens opacity, toxic retinopathy); the genitourinary system (hematuria, hemorrhagic cystitis, and albuminuria); cardiovascular system (hypertension, orthostatic hypotension, and flushing); and some miscellaneous effects including generalized aching, hyperpyrexia, and lowered protein bound iodine (PBI)…