Onivyde Use In Pregnancy & Lactation

Women of childbearing potential/contraception in males and females: Women of childbearing potential should use effective contraception during ONIVYDE pegylated liposomal treatment and 7 months thereafter. Males should use condoms during ONIVYDE pegylated liposomal treatment and 4 months thereafter.
Pregnancy: There are no adequate data on the use of ONIVYDE pegylated liposomal in pregnant women. ONIVYDE pegylated liposomal can cause harm to the foetus when administered to the pregnant woman, as the main ingredient irinotecan has been shown to be embryotoxic and teratogenic in animals (see Pharmacology: Toxicology: Preclinical safety data under Actions). Therefore, based on results from animal studies and the mechanism of action of irinotecan, ONIVYDE pegylated liposomal should not be used during pregnancy unless clearly necessary. If ONIVYDE pegylated liposomal is used during pregnancy or if the patient becomes pregnant while receiving therapy, the patient should be informed about the potential hazard to the foetus.
Breast-feeding: It is unknown whether ONIVYDE pegylated liposomal or its metabolites are excreted into human milk. Because of the potential for serious adverse reactions of ONIVYDE pegylated liposomal in breast-feeding infants, ONIVYDE pegylated liposomal is contraindicated during breast-feeding (see Contraindications). Patients should not breast-feed until one month after the last dose.
Fertility: There are no data on the impact of ONIVYDE pegylated liposomal on human fertility. Non-liposomal irinotecan was shown to cause atrophy of male and female reproductive organs after multiple daily irinotecan doses in animals (see Pharmacology: Toxicology: Preclinical safety data under Actions). Prior to starting the administration of ONIVYDE pegylated liposomal, consider advising patients on the preservation of gametes.