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Mitotane Pregnancy and Breastfeeding Warnings

Mitotane is also known as: Lysodren

Mitotane Pregnancy Warnings

Animal reproduction studies have not been conducted. Mitotane can cause fetal harm when administered to a pregnant woman. Abnormal pregnancy outcomes such as preterm births and early pregnancy loss have been reported. The use of mitotane has rarely been associated with (reversible) primary hypogonadism and impotence in males. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: D Can cause fetal harm but potential benefits may warrant use of the drug in pregnant women despite potential risks. Advise women of childbearing potential to use effective contraception during treatment and after discontinuation of treatment for as long as mitotane plasma levels are detectable.

Mitotane Breastfeeding Warnings

Breastfeeding is not recommended during therapy and for as long as mitotane plasma levels are detectable. Excreted into human milk: Yes Excreted into animal milk: Data not available The effects in the nursing infant are unknown.

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