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Mitotane Pregnancy and Breastfeeding Warnings

Mitotane is also known as: Lysodren

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mitotane while you are pregnant. It is not known if Mitotane is found in breast milk. Do not breast-feed while taking Mitotane.

Mitotane Pregnancy Warnings

Mitotane has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been conducted with mitotane. There are no controlled data from human pregnancy studies. It is also not known whether mitotane can cause fetal harm when administered to a pregnant woman. The use of mitotane has rarely been associated with (reversible) primary hypogonadism and impotence in males. Mitotane should only be given during pregnancy when benefit outweighs risk.

Mitotane Breastfeeding Warnings

There are no data on the excretion of mitotane into human milk. Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from mitotane, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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