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 6-20 times higher than those observed at the clinical dose of 10 mg/kg of durvalumab (based on AUC) was associated with premature delivery, fetal loss (abortion and stillbirth) and an increase in neonatal deaths compared to concurrent control (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 fetal harm when administered to a pregnant woman. Human IgG1 is known to cross the placental barrier. Imfinzi cannot be used during pregnancy, unless this is absolutely required. Women of childbearing potential should use effective contraception during treatment with IMFINZI 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 breastfed 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 breastfed infants from durvalumab, advise a lactating woman not to breastfeed during treatment and for at least 3 months after the last dose.