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, Caelyx 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 Caelyx 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 Caelyx liposomal and for 6 months following completion of treatment.
Breast-feeding
It is not known whether Caelyx 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 Caelyx 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).