Pregnancy & Lactation : הריון/הנקה

4.6      Fertility, pregnancy and lactation
Pregnancy
There are limited amount data from the use of idarubicin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
Idarubicin should not be used during pregnancy unless only if the potential benefit justifies the potential risk to the foetus. The patient should be informed of the potential hazard to the foetus.
Women of childbearing potential/ Contraception in males and females
Women of child bearing potential should be advised not to become pregnant and to use effective contraception during treatment with idarubicin 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 and for at least 3.5 months after the last dose (see section 4.4).
Breast-feeding
It is not known whether idarubicin passes into breast milk. As other anthracyclines are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from idarubicin, women should be advised not to breastfeed during treatment with idarubicin and for at least 14 days after the last dose.
Fertility
Idarubicin can cause chromosome damage in human spermatozoa and/or infertility. For these reasons, men treated with idarubicin should use effective contraceptive methods for at least 3.5 months after the last dose (see section 4.4). Both men and women should seek advice on fertility preservation before treatment.