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Pregnancy: There are no data from the use of cabazitaxel in pregnant women. Studies in animals have shown reproductive toxicity at maternotoxic doses (see Pharmacology: Toxicology: Preclinical Safety Data under Actions) and that cabazitaxel crosses the placenta barrier (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). As with other cytotoxic medicinal products, cabazitaxel may cause foetal harm in exposed pregnant women.
Cabazitaxel is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: Available pharmacokinetics data in animals have shown excretion of cabazitaxel and its metabolites in milk (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). A risk to the suckling child cannot be excluded.
Cabazitaxel should not be used during breast‑feeding.
Fertility: Animal studies showed that cabazitaxel affected reproductive system in male rats and dogs without any functional effect on fertility (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). Nevertheless, considering the pharmacological activity of taxanes, their genotoxic potential and effect of several compounds of this class on fertility in animal studies, effect on male fertility could not be excluded in human.
Due to potential effects on male gametes and to potential exposure via seminal liquid, men treated with cabazitaxel should use effective contraception throughout treatment and are recommended to continue this for up to 6 months after the last dose of cabazitaxel. Due to potential exposure via seminal liquid, men treated with cabazitaxel should prevent contact with the ejaculate by another person throughout treatment. Men being treated with cabazitaxel are advised to seek advice on conservation of sperm prior to treatment.
