Kadcyla Use In Pregnancy & Lactation

Pregnancy: No clinical studies of Kadcyla in pregnant women have been performed. No reproductive and developmental toxicology studies have been conducted with Kadcyla.
Trastuzumab, a component of Kadcyla, can cause fetal harm or death when administered to a pregnant woman. In the post-marketing setting, cases of oligohydramnios, some associated with fatal pulmonary hypoplasia, have been reported in pregnant women receiving trastuzumab. Animal studies of maytansine, a closely related chemical entity of the same maytansinoid class as DM1, suggest that DM1, the microtubule inhibiting cytotoxic drug component of Kadcyla, is expected to be teratogenic and potentially embryotoxic.
Administration of Kadcyla to pregnant women is not recommended. Women who become pregnant must contact their doctor and should be advised of the possibility of harm to the fetus. If a pregnant woman is treated with Kadcyla, close monitoring by a multidisciplinary team is recommended.
Labor and Delivery: The safe use of Kadcyla during labor and delivery has not been established.
Lactation: It is not known whether Kadcyla is excreted in human breast milk. Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Kadcyla, women should discontinue nursing prior to initiating treatment with Kadcyla. Women may begin nursing 7 months following the last dose of Kadcyla.