Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
Pregnancy:
Doxorubicin hydrochloride is suspected to cause serious birth defects when administered during pregnancy.
Therefore, Lipodox Liposomal should not be used during pregnancy unless clearly necessary.
Women of childbearing potential/contraception in men and women:
Due to the genotoxic potential of doxorubicin hydrochloride (see section 5.3), women of childbearing potential should use effective contraceptive measures while being treated with Lipodox Liposomal and for 8 months following completion of treatment.
Men are recommended to use effective contraceptive measures and to not father a child while receiving Lipodox Liposomal and for 6 months following completion of treatment.
Breast-feeding:
It is not known whether Lipodox Liposomal is excreted in human milk. Because many medicinal products, including anthracyclines, are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, therefore mothers must discontinue nursing prior to beginning Lipodox Liposomal treatment.
Health experts recommend that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Fertility:
The effect of doxorubicin hydrochloride on human fertility has not been evaluated (see section 5.3).