Daxotel Use In Pregnancy & Lactation

Pregnancy: Category D.
Docetaxel can cause fetal harm when administered to pregnant women. Studies in rats and rabbits at doses of 0.3 and 0.03 mg/kg/day or greater, respectively (about 1/50 and 1/300 the daily maximum recommended human dose on a mg/m² basis), administered during the period of organogenesis, have shown that Docetaxel is embryotoxic and fetotoxic (characterized by intrauterine mortality, increased resorption, reduced fetal weight, and fetal ossification delay). The doses indicated above also caused maternal toxicity.
There are no adequate and well-controlled studies in pregnant women using Docetaxel. If Docetaxel is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during therapy.
Lactation: It is not known whether Docetaxel is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Docetaxel, have the mother discontinue nursing prior to using this drug.