Women of childbearing potential: Patients of child-bearing potential should be advised to use effective contraception while on treatment.
Pregnancy: Faslodex is contraindicated in pregnancy (see Contraindications). Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit. Studies in animals have shown reproductive toxicity including an increased incidence of foetal abnormalities and deaths (see Pharmacology: Toxicology: Preclinical safety data under Actions). If pregnancy occurs while taking Faslodex, the patient must be informed of the potential hazard to the foetus and potential risk for loss of pregnancy.
Breastfeeding: Breastfeeding must be discontinued during treatment with Faslodex. Fulvestrant is excreted in milk in lactating rats. It is not known whether fulvestrant is excreted in human milk. Considering the potential for serious adverse reactions due to fulvestrant in breast-fed infants, use during lactation is contraindicated (see Contraindications).
Fertility: The effects of Faslodex on fertility in humans has not been studied.