Newtaxel-A Use In Pregnancy & Lactation

Docetaxel can cause fetal harm when administered to pregnant women. Studies in both rats and rabbits at doses ≥0.3 and 0.03 mg/kg/day, 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 or potential risk for loss of the pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Docetaxel.
It is not known whether Docetaxel is excreted in human milk. Because many drugs are excreted inhuman milk, and because of the potential for serious adverse reactions in nursing infants from Docetaxel, a decision should be made whether to discontinue nursing or to discontinue the drug,taking into account the importance of the drug to the mother.