Effects of Tofacitinib on the Fetus

In perinatal and postnatal studies in rats, (Tofacitinib resulted in decreased live litter size, postnatal survival, and pup body weight at exposures that were approximately 73 times the recommended dose of 5 mg twice daily and approximately 36 times the maximum recommended dose of 10 mg twice daily. There are currently no data on the presence of tofacitinib in breast milk and the effects on the breastfed infant or on milk production, and the available data on the use of tofacitinib in pregnant women are insufficient to determine a drug-related risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Breastfeeding is not recommended for patients during treatment and for at least 18 hours after the last dose of tofacitinib tablets, extended-release tablets, or oral solution, or for 36 hours after the last dose of tofacitinib.