Imfinzi Use In Pregnancy & Lactation

Pregnancy: In animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys from the confirmation of pregnancy through delivery at exposure levels approximately 22 times higher than those observed at the clinical dose of 10 mg/kg of durvalumab (based on AUC) was not associated with maternal toxicity or effects on embryofoetal development, pregnancy outcome or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no data on the use of durvalumab in pregnant women. Based on its mechanism of action, durvalumab has the potential to impact maintenance of pregnancy and may cause foetal harm when administered to a pregnant woman. Human IgG1 is known to cross the placental barrier. Durvalumab is not recommended during pregnancy and in women of childbearing potential not using effective contraception during treatment and for at least 3 months after the last dose.
Breast-feeding: There is no information regarding the presence of durvalumab in human milk, the absorption and effects on the breast-fed infant, or the effects on milk production. Human IgG is excreted in human milk. In animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys was associated with dose-related low level excretion of durvalumab in breast milk. Because of the potential for adverse reactions in breast-fed infants from durvalumab, advise a lactating woman not to breast-feed during treatment and for at least 3 months after the last dose.
Fertility: There are no data on the potential effects of durvalumab on fertility in humans. In repeat-dose toxicology studies with durvalumab in sexually mature cynomolgus monkeys of up to 3 months duration, there were no notable effects on the male and female reproductive organs.