Pregnancy: There are no or limited amount of data on the use of CIBINQO in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). CIBINQO is contraindicated during pregnancy (see Contraindications).
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 is encouraged.
Breast-feeding: There are no data on the presence of CIBINQO in human milk, the effects on the breast-fed infant, or the effects on milk production. CIBINQO was secreted in milk of lactating rats. A risk to newborns/infants cannot be excluded and CIBINQO is contraindicated during breast-feeding.
Fertility: Based on the findings in rats, oral administration of 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 CIBINQO oral administration (see Pharmacology: Toxicology: Preclinical safety data under Actions).