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Mitotane Pregnancy and Breastfeeding Warnings

Mitotane is also known as: Lysodren

Medically reviewed on November 13, 2017

Mitotane Pregnancy Warnings

Abnormal pregnancy outcomes such as preterm births, early pregnancy loss, fetal adrenal abnormalities have been reported in patients exposed to this drug during pregnancy. Animal reproduction studies with this drug have not been conducted, but animal studies with similar substances have shown evidence of reproductive toxicity.

US 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.

This drug can cause fetal harm; it should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus.

US FDA pregnancy category: D

Comments: Women of childbearing potential should be advised not to get pregnant during therapy due to the potential hazard to a fetus/potential risk for pregnancy loss, and they should use effective contraception during treatment and after treatment discontinuation for as long as plasma levels of this drug are detectable.

See references

Mitotane Breastfeeding Warnings

-Breastfeeding is contraindicated during treatment and after treatment cessation for as long as plasma levels of this drug are detectable. (UK)
-Breastfeeding should be discontinued during treatment and after treatment cessation for as long as plasma levels of this drug are detectable. (US)

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Lysodren (mitotane)." Bristol-Myers Squibb, Princeton, NJ.

References for breastfeeding information

  1. "Product Information. Lysodren (mitotane)." Bristol-Myers Squibb, Princeton, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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