Pregnancy & Lactation : הריון/הנקה

4.6     Fertility, pregnancy and lactation

Impairment of Fertility
Epirubicin could induce chromosomal damage in human spermatozoa. Men undergoing treatment with epirubicin 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. Men, who are treated with epirubicin, should not farther a child during treatment and up to 6 months thereafter.
Epirubicin 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 up to 6 months thereafter and should use effective contraceptive methods.

Experimental data in animals suggest that epirubicin may cause foetal harm when administered to a pregnant woman. If epirubicin is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the foetus.

There are no studies in pregnant women. Epirubicin should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Lactation
It is not known whether epirubicin is excreted in human milk. Because many drugs, including other anthracyclines, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from epirubicin, mothers should discontinue nursing prior to taking this drug.