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Trametinib Pregnancy and Breastfeeding Warnings

Trametinib is also known as: Mekinist

Trametinib Pregnancy Warnings

Trametinib is embryotoxic and abortifacient in rabbits at exposures 0.3 times the human clinical exposure at the recommended dose. There are no controlled data in human pregnancy. 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 Trametinib can cause fetal harm. 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 the fetus. Comments: Female patients of reproductive potential should use a highly effective method of contraception during treatment and for 4 months after treatment.

Trametinib Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue trametinib, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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