Use in pregnancy Category D: Studies have shown paclitaxel to be toxic to embryos and foetuses in rabbits at an intravenous dose of 3 mg/kg (33 mg/m2) given during organogenesis. Paclitaxel is toxic to rat foetuses at a dose of 1 mg/kg (6 mg/m2). Examination revealed that no gross external, soft tissue or skeletal alterations occurred.
Category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.
Use in lactation: The evidence from many drugs would suggest that paclitaxel could be excreted in breast milk, though this is not known. Because infants receiving the drug could experience serious adverse effects, breastfeeding should be discontinued while the mother is undergoing treatment.