Jemperli Use In Pregnancy & Lactation

Women of childbearing potential/Contraception: There is a risk associated with the administration of dostarlimab to women of childbearing potential. Women of childbearing potential must use effective contraception during treatment with dostarlimab and until 4 months after the last dose of dostarlimab.
Pregnancy: There are no or limited amount of data on the use of dostarlimab in pregnant women. Based on its mechanism of action, dostarlimab can cause foetal harmful pharmacological effects when administered during pregnancy.
Animal reproduction and development studies have not been conducted with dostarlimab; however, inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing foetus resulting in foetal death (see Pharmacology: Toxicology: Preclinical safety data under Actions). Human immunoglobulins (IgG4) are known to cross the placental barrier, and therefore, being an IgG4, dostarlimab has the potential to be transmitted from the mother to the developing foetus.
JEMPERLI is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is unknown whether dostarlimab/metabolites are excreted in human milk.
A risk to the newborns/infants cannot be excluded.
JEMPERLI should not be used during breast-feeding and breast-feeding should be avoided for at least 4 months after the last dose of dostarlimab.
Fertility: Fertility studies have not been conducted with dostarlimab (see Pharmacology: Toxicology: Preclinical safety data under Actions).