Imjudo Use In Pregnancy & Lactation

Pregnancy: In animal reproduction studies, administration of tremelimumab to pregnant cynomolgus monkeys during the period of organogenesis was not associated with maternal toxicity or any effects on pregnancy maintenance or embryofoetal development (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no data on the use of tremelimumab in pregnant women. Based on its mechanism of action, tremelimumab has the potential to impact pregnancy maintenance and may cause foetal harm when administered to a pregnant woman. Human IgG2 is known to cross the placental barrier. Tremelimumab 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 tremelimumab in human milk, the absorption and effects on the breastfed infant, or the effects on milk production. Human IgG2 is excreted in human milk. Because of the potential for adverse reactions from tremelimumab in breastfed infants, lactating women are advised not to breastfeed during treatment and for at least 3 months after the last dose.
Fertility: There are no data on the potential effects of tremelimumab on fertility in humans.