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Ado-trastuzumab emtansine Pregnancy and Breastfeeding Warnings

Ado-trastuzumab emtansine is also known as: Kadcyla

Ado-trastuzumab emtansine Pregnancy Warnings

FDA pregnancy category: D Use of ado-trastuzumab emtansine is not recommended. Comments: Patients should be advised to use effective contraception during treatment and for 6 months following the last dose of ado-trastuzumab emtansine.

There are no adequate and well-controlled studies of ado-trastuzumab emtansine in pregnant women. Use of trastuzumab, the antibody component of ado-trastuzumab emtansine, during pregnancy has resulted in oligohydramnios, associated with fatal pulmonary hypoplasia, skeletal abnormalities and neonatal death. DM1, the cytotoxic component of ado-trastuzumab emtansine, can be expected to cause embryofetal toxicity based on its mechanism of action. If a patient is exposed to ado-trastuzumab emtansine during pregnancy apprise the patient of the potential hazard to the fetus, immediately report exposure to the Genentech Adverse Event Line at 1-888-835-2555 and encourage the patient to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720. 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.

Ado-trastuzumab emtansine Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, 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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