Tofacitinib and Breastfeeding
Breastfeeding should be avoided during tofacitinib treatment and for at least 18 hours after the last dose of immediate-release formulations (or 36 hours after extended-release formulations), as explicitly stated in the FDA drug label. 1
Regulatory and Guideline Recommendations
The FDA-approved prescribing information for tofacitinib (Xeljanz) explicitly advises women not to breastfeed during treatment and for at least 18 hours after the last dose of immediate-release tablets or oral solution, or 36 hours after the last dose of extended-release tablets. 1
The British Society of Gastroenterology 2025 guidelines state that tofacitinib should be avoided during lactation due to insufficient safety data. 2
The American College of Rheumatology and European League Against Rheumatism recommend that all JAK inhibitors, including tofacitinib, should be avoided during breastfeeding due to insufficient data on infant safety. 3
Evidence Base and Safety Concerns
There is extremely limited human data on tofacitinib concentrations in breast milk and no systematic studies evaluating infant outcomes after maternal exposure through breastfeeding. 4
A 2025 study specifically designed to assess tofacitinib in pregnancy, cord blood, and breast milk concentrations confirms that evidence remains scarce, with drug regulatory agencies and international guidelines uniformly recommending avoidance during lactation. 4
The theoretical concern stems from tofacitinib's mechanism of action as a JAK1/JAK3 inhibitor that affects multiple cytokine signaling pathways critical for immune function, raising concerns about potential immunosuppression in nursing infants. 2
Clinical Implementation
If a breastfeeding patient requires tofacitinib for active inflammatory disease (rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis), counsel her to discontinue breastfeeding before initiating therapy. 1
For patients who have taken a single dose or short course of tofacitinib, advise pumping and discarding breast milk for at least 18 hours (immediate-release) or 36 hours (extended-release) before resuming breastfeeding. 1
Consider alternative therapeutic options with established safety profiles during lactation when treating conditions like ulcerative colitis or rheumatoid arthritis in breastfeeding women. 2
Common Pitfalls to Avoid
Do not assume that the short half-life of tofacitinib (approximately 3 hours) makes it safe for breastfeeding—the FDA-mandated washout period of 18-36 hours accounts for complete drug elimination and potential active metabolites. 1
Avoid initiating tofacitinib in women of childbearing potential without comprehensive counseling about contraception requirements and the need to avoid breastfeeding, as pregnancy and lactation planning must be addressed before treatment starts. 3, 1
Do not rely on the absence of reported adverse events in case reports as evidence of safety—the lack of systematic data collection means the true risk to nursing infants remains unknown. 4