Pregnancy: In animal testing, paclitaxel was embryotoxic and foetotoxic and reduced fertility.
There is no experience in pregnant women. As with other cytotoxic substances, paclitaxel can cause harm to the foetus.
The drug is contraindicated during pregnancy (see Contraindications).
Patients should be instructed to avoid pregnancy during Taxol treatment and to consult the treating physician immediately if a pregnancy occurs.
Lactation: It is not known whether paclitaxel is excreted into breast milk. Therefore, Taxol is contraindicated during lactation (see Contraindications).
Fertility: Given the mutagenic potential of Taxol, effective contraception is required in both male and female patients during treatment and for up to six months after the end of treatment. As Taxol can impair male fertility, cryoconservation of sperm may be considered for the purposes of fathering children later (see Pharmacology: Toxicology: Preclinical Data under Actions).