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There are no adequate and well-controlled studies on the use of XELJANZ in pregnant women. Tofacitinib has been shown to be teratogenic in rats and rabbits, and have effects in rats on female fertility, parturition, and peri/post-natal development (see Pharmacology: Toxicology: Non-clinical safety data under Actions). XELJANZ should not be used during pregnancy unless clearly necessary.
Women of reproductive potential should be advised to use effective contraception during treatment with XELJANZ and for at least 4 weeks after the last dose.
Based on published data, tofacitinib is present in human milk. Information on the effects of tofacitinib on the breastfed infant from published literature and post-marketing data is limited to a small number of cases with no causally related adverse events. There are no data on the effects on milk production. Women should not breastfeed while treated with XELJANZ.
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