Pregnancy: Doxorubicin hydrochloride is suspected to cause serious birth defects when administered during pregnancy. Therefore, Caelyx pegylated liposomal should not be used during pregnancy unless clearly necessary.
Women of child-bearing potential: Women of child-bearing potential must be advised to avoid pregnancy while they or their male partner are receiving Caelyx pegylated liposomal and in the six months following discontinuation of Caelyx pegylated liposomal therapy (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Breast-feeding: It is not known whether Caelyx pegylated 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 pegylated 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 Pharmacology: Toxicology: Preclinical safety data under Actions).