Imjudo Use In Pregnancy & Lactation

Women of childbearing potential/Contraception: Women of childbearing potential should use effective contraception during treatment with tremelimumab and for at least 3 months after the last dose of tremelimumab.
Pregnancy: There are no data on the use of tremelimumab in pregnant women. Based on its mechanism of action, and placental transfer of human IgG2, tremelimumab has the potential to impact maintenance of pregnancy and may cause foetal harm when administered to a pregnant woman. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. (See Pharmacology: Toxicology: Preclinical safety data under Actions.) Tremelimumab (IMJUDO) 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 breast-fed infant, or the effects on milk production. Human IgG2 is known to be excreted in human milk. A risk to the breastfed child cannot be excluded. Breast-feeding should be discontinued during treatment with Tremelimumab (IMJUDO) 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 or animals. However, mononuclear cell infiltration in prostate and uterus was observed in repeat-dose toxicity studies (see Pharmacology: Toxicology: Preclinical safety data under Actions). The clinical relevance of these findings for fertility is unknown.