Cibinqo Use In Pregnancy & Lactation

Women of childbearing potential: Women of reproductive potential should be advised to use effective contraception during treatment and for 1 month following the final dose of CIBINQO. Pregnancy planning and prevention for females of reproductive potential should be encouraged.
Pregnancy: There are no or limited amount of data on the use of abrocitinib in pregnant women. Studies in animals have shown reproductive toxicity. Abrocitinib has been shown to cause embryo-foetal lethality in pregnant rats and rabbits, skeletal variations in the foetuses of pregnant rats and rabbits, and to affect parturition and peri/postnatal development in rats (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). CIBINQO is contraindicated during pregnancy (see Contraindications).
Breast-feeding: There are no data on the presence of abrocitinib in human milk, the effects on the breast-fed infant, or the effects on milk production. Abrocitinib was secreted in milk of lactating rats. A risk to newborns/infants cannot be excluded and CIBINQO is contraindicated during breast-feeding (see Contraindications).
Fertility: Based on the findings in rats, oral administration of CIBINQO may result in temporary reduced fertility in females of reproductive potential. The effects on female rat fertility were reversible 1 month after cessation of abrocitinib oral administration (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).