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 Abrocitinib (Cibinqo). Consider pregnancy planning and prevention for females of reproductive potential.
Pregnancy: The limited human data on use of Abrocitinib (Cibinqo) in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. In embryo-fetal development studies, oral administration of Abrocitinib (Cibinqo) to pregnant rats during organogenesis resulted in fetotoxicity at exposures equal to 17 times the unbound AUC at the maximum recommended human dose (MRHD) of 200 mg once daily. In embryo-fetal development studies, oral administration of Abrocitinib (Cibinqo) to pregnant rabbits did not result in fetotoxicity at exposures equal to 4 times the unbound AUC at the MRHD of 200 mg. In a pre and postnatal development study in pregnant rats, Abrocitinib (Cibinqo) oral administration during gestation and through lactation resulted in lower postnatal survival and lower offspring body weights at exposures greater than or equal to 11 times the unbound AUC at the MRHD of 200 mg once daily (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). Abrocitinib (Cibinqo) should not be used during pregnancy unless clearly necessary.
Breastfeeding: There are no data on the presence of Abrocitinib (Cibinqo) in human milk, the effects on the breastfed infant, or the effects on milk production. Abrocitinib (Cibinqo) was secreted in milk of lactating rats. A risk to newborns/infants cannot be excluded and Abrocitinib (Cibinqo) should not be used during breastfeeding.
Fertility: Based on the findings in rats, oral administration of Abrocitinib (Cibinqo) may result in temporary reduced fertility in females of reproductive potential. These effects on female rat fertility were reversible 1 month after cessation of Abrocitinib (Cibinqo) oral administration (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).