Effects on fertility: Following treatment with intravenous paclitaxel at a dose of 1 mg/kg (6 mg/m2), rats showed decreased fertility and toxicity in unborn offspring. Paclitaxel administered intravenously to rabbits during organogenesis at a dose of 3 mg/kg (33 mg/m2) was toxic to both mother and foetus.
Infertility in females and males: Based on findings in animal studies, ANZATAX may impair fertility in females and males of reproductive potential.
Use in pregnancy (Category D1): Paclitaxel is a cytotoxic agent that can produce spontaneous abortion, foetal loss and birth defects and may cause foetal harm when administered to a pregnant woman. 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) and produced low fertility and foetal toxicity in rats. Examination revealed that no gross external, soft tissue or skeletal alterations occurred. There are no studies in pregnant women.
Women of childbearing potential should have a pregnancy test prior to starting treatment with ANZATAX. These women should be strongly advised to use effective contraception throughout therapy and for at least six months after the last dose of ANZATAX. If paclitaxel is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard.
1 Category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human foetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.
Females and males of reproductive potential: Males: Based on findings in genetic toxicity and animal reproduction studies, males should be advised to use effective contraception in order to avoid fathering a child during treatment and for at least three months after the last dose of ANZATAX.
Females: Women of childbearing potential should be advised to use effective contraception in order to avoid becoming pregnant during treatment and for at least six months after the last dose of ANZATAX.
Use in lactation: It is not known whether paclitaxel is excreted in human milk. 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.