Pregnancy: Pregnancy Category B.
Risk Summary: Adequate and well controlled studies with ALOXI have not been conducted in pregnant women. In animal reproduction studies, no effects on embryo-fetal developments were observed with the administration of oral palonosetron during the period of organogenesis at doses up to 1894 and 3789 times the recommended human intravenous dose in rats and rabbits, respectively. Because animal reproduction studies are not always predictive of human response, ALOXI should be used during pregnancy only if clearly needed.
Animal Data: In animal studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron at doses up to 60 mg/kg/day (1894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral doses up to 60 mg/kg/day (3789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis.
Nursing Mothers: It is not known whether ALOXI is present in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants and the potential for tumorigenicity shown for palonosetron in the rat carcinogenicity study [see Pharmacology: Nonclinical Toxicology: Carcinogenesis, Mutagenesis, Impairment of Fertility under Actions], a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.