Pregnancy: There are no data on the use of pembrolizumab in pregnant women. Animal reproduction studies have not been conducted with pembrolizumab; however, blockade of PD-L1 signaling has been shown in murine models of pregnancy to disrupt tolerance to the fetus and to result in an increase in fetal loss. These results indicate a potential risk, based on its mechanism of action, that administration of Pembrolizumab (KEYTRUDA) during pregnancy could cause fetal harm, including increased rates of abortion or stillbirth. Human IgG4 (immunoglobulin) is known to cross the placental barrier and pembrolizumab is an IgG4; therefore, pembrolizumab has the potential to be transmitted from the mother to the developing fetus. Pembrolizumab (KEYTRUDA) is not recommended during pregnancy unless the clinical benefit outweighs the potential risk to the fetus. Women of childbearing potential should use effective contraception during treatment with Pembrolizumab (KEYTRUDA) and for at least 4 months after the last dose of Pembrolizumab (KEYTRUDA).
Nursing Mothers: It is unknown whether Pembrolizumab (KEYTRUDA) is secreted in human milk. Because many drugs are secreted in human milk, a decision should be made whether to discontinue breast-feeding or to discontinue Pembrolizumab (KEYTRUDA), taking into account the benefit of breast-feeding for the child and the benefit of Pembrolizumab (KEYTRUDA) therapy for the woman.