Women of Childbearing Potential: Women of childbearing potential should be advised to use effective contraception during treatment and for 4 weeks following the final dose of upadacitinib.
Pregnancy: There are no or limited data on the use of upadacitinib in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Upadacitinib was teratogenic in rats and rabbits with effects in bones in rat foetuses and in the heart in rabbit foetuses when exposed in utero.
Upadacitinib is contraindicated during pregnancy (see Contraindications).
If a patient becomes pregnant while taking upadacitinib the parents should be informed of the potential risk to the foetus.
Breast-feeding: It is unknown whether upadacitinib/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of upadacitinib in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
A risk to newborns/infants cannot be excluded.
Upadacitinib should not be used during breast-feeding. A decision must be made whether to discontinue breast-feeding or to discontinue upadacitinib therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: The effect of upadacitinib on human fertility has not been evaluated. Animal studies do not indicate effects with respect to fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).