Impairment of Fertility: Daunorubicin could induce chromosomal damage in human spermatozoa. Men undergoing treatment with daunorubicin should use effective contraceptive methods.
Pregnancy: Like most other anticancer drugs, daunorubicin has shown teratogenic, mutagenic and carcinogenic potential in animals. According to experimental data, the drug must be considered as a potential cause of fetal malformations when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women, although a few women who received daunorubicin during the second and third trimesters of pregnancy have delivered apparently normal infants.
As a general rule, it is recommended that daunorubicin not be administered to patients who are pregnant. If the drug is used during pregnancy, or if the patient becomes pregnant while receiving the drug, the woman should be informed of the potential hazard to the fetus. Women of child-bearing potential who have to undergo daunorubicin therapy should be apprised of the potential hazard to the fetus and should be advised to avoid becoming pregnant during treatment. Daunorubicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether daunorubicin is excreted in human milk. As a general rule, it is recommended that daunorubicin not be administered to mothers who are breast-feeding.