Zavedos Use In Pregnancy & Lactation

(See Pharmacology: Toxicology: Preclinical safety data under Actions).
Impairment of Fertility: Idarubicin hydrochloride can induce chromosomal damage in human spermatozoa. For this reason, males undergoing treatment with idarubicin hydrochloride should use effective contraceptive methods. Both men and women should seek advice on fertility preservation before treatment.
Pregnancy: The embryotoxic potential of idarubicin hydrochloride has been demonstrated in both in vitro and in vivo studies. However, there are no adequate and well-controlled studies in pregnant women.
Idarubicin hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The patient should be informed of the potential hazard to the fetus.
Women of Childbearing Potential/Contraception in Males and Females: Women of childbearing potential should be advised to avoid becoming pregnant during treatment. Women of childbearing potential should be advised to use effective contraception during treatment with idarubicin hydrochloride and for at least 6.5 months after the last dose. Men with female partners of childbearing potential should be advised to use effective contraception during treatment with idarubicin hydrochloride and for at least 3.5 months after the last dose.
Lactation: It is not known whether idarubicin hydrochloride or its metabolites are 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 idarubicin, advise lactating women not to breastfeed during treatment with idarubicin and for at least 14 days after last dose.