Fertility: Epirubicin hydrochloride could induce chromosomal damage in human spermatozoa. Men undergoing treatment with epirubicin hydrochloride should use effective contraceptive methods and if appropriate and available, seek advice on sperm preservation due to the possibility of irreversible infertility caused by therapy.
Epirubicin hydrochloride may cause amenorrhoea or premature menopause in premenopausal women.
Pregnancy: Women of child-bearing potential should be advised to avoid becoming pregnant during treatment and should use effective contraceptive methods.
Experimental data in animals suggest that epirubicin hydrochloride may cause foetal harm when administered to a pregnant woman. If epirubicin hydrochloride is used during pregnancy or if the patient becomes pregnant while taking this medicinal product, the patient should be apprised of the potential hazard to the foetus.
There are no studies in pregnant women. Epirubicin hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Breast-feeding: It is not known whether epirubicin hydrochloride is excreted in human milk. Because many medicinal products, including other anthracyclines, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from epirubicin hydrochloride, mothers should discontinue nursing prior to taking this medicinal product.