Litfulo Use In Pregnancy & Lactation

Women of childbearing potential: Ritlecitinib is not recommended in women of childbearing potential not using contraception. Women of childbearing potential have to use effective contraception during treatment and for 1 month following the final dose of LITFULO.
Pregnancy: There are no or limited data from the use of ritlecitinib in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Ritlecitinib was teratogenic in rats and rabbits at high doses (see Pharmacology: Toxicology: Preclinical safety data under Actions). LITFULO is contraindicated during pregnancy (see Contraindications).
Breast-feeding: Available pharmacodynamic/toxicological data in animals have shown excretion of ritlecitinib in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to newborns/infants cannot be excluded. LITFULO is contraindicated during breast-feeding (see Contraindications).
Fertility: The effect of ritlecitinib on human fertility has not been evaluated. There were no effects on fertility in rats at clinically relevant exposure (see Pharmacology: Toxicology: Preclinical safety data under Actions).