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MotherToBaby

Medications and More during pregnancy and breastfeeding

Tofacitinib (Xeljanz®, Xeljanz XR®)

Selected References:

  • Clowse M, et al. 2016. Pregnancy outcomes in the tofacitinib safety databases for rheumatoid arthritis and psoriasis. Drug Saf; 39(8):755-762. 
  • Fernández-Sánchez M, et al. 2021. Fetal exposure to tofacitinib during the first trimester: A healthy newborn case report. Birth Defects Res; 113(17):1275-1279.  
  • Julsgaard M, et al. 2023. Tofacitinib concentrations in plasma and breastmilk of a lactating woman with ulcerative colitis. Lancet Gastroenterol Hepatol; 8:695–697. 
  • Mahadevan U, et al. 2018. Outcomes of pregnancies with maternal/paternal exposure in the tofacitinib safety databases for ulcerative colitis. Inflammatory Bowel Diseases 24(12):2494–2500.  
  • Mahadevan U, et al. 2019. Inflammatory bowel disease in pregnancy clinical care pathway: A report from the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology 156(5):1508-1524. 
  • Mahadevan U, et al. 2025. Pregnancy Outcomes After Maternal or Paternal Exposure to Tofacitinib Across Clinical Programs. Am J Gastroenterol. Epub ahead of print. PMID: 4100213.  
  • Merren A, et al. 2015. THU0173 Pregnancy outcomes in the tofacitinib RA study database through April 2014.  Annals of the Rheumatic Diseases 74:256-257. 
  • Mitrova K, et al. 2025. Assessing pregnancy and infant outcomes, cord blood and breast milk concentrations. Clin Gastroenterol Hepatol; 23:163–5.e3. 
  • Picardo S, Seow CH. 2019. A pharmacological approach to managing inflammatory bowel disease during conception, pregnancy and breastfeeding: Biologic and oral small molecule therapy. Drugs 79(10):1053-1063. 
  • Rüegg L, et al. 2025. EULAR recommendations for use of antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. Ann Rheum Dis84:910–926. 
  • Selinger C, et al. 2024. Appropriateness of small molecule agents for patients with IBD of childbearing age – a RAND/UCLA appropriateness panel. Therap Adv Gastroenterol 2024;17:17562848241299737.  
  • U.S. Pharmaceuticals. Xeljanz/Xeljanz XR Prescribing Information. 2025. Available online at:  https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=68e3d6b2-7838-4d2d-a417-09d919b43e13&type=pdf Accessed 27 January 2026.  

 

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