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MotherToBaby

Medications and More during pregnancy and breastfeeding

Vedolizumab (Entyvio®)

Selected References:

  • Barrau M, et al. 2023. What should we know about drug levels and therapeutic drug monitoring during pregnancy and breastfeeding in inflammatory bowel disease under biologic therapy? J Clin Med; 12(23):7495. 
  • Bell C, et al. 2021. Systematic review and meta-analysis: Safety of vedolizumab during pregnancy in patients with inflammatory bowel disease. J Gastroenterol Hepatol; 36(10):2640-2648.  
  • Caballero-Mateos AM, et al. 2023. IBD and motherhood: A journey through conception, pregnancy and beyond. J Clin Med; 12(19):6192. 
  • Chambers CD, et al. 2026. Birth outcomes in women who have taken vedolizumab in pregnancy: Results from the vedolizumab pregnancy exposure registry. Am J Gastroenterol; 1;121(3):720-732. 
  • Chugh R. 2023. Maternal and neonatal outcomes in vedolizumab and ustekinumab exposed pregnancies: Results from the PIANO registry. Am J Gastroenterol; 1;119(3):468-476. 
  • Ding N, et al. 2022. Management of biologics in pregnant, lactating patients with inflammatory bowel disease and the impact on neonatal vaccination: A systematic review of clinical practice guidelines and consensus statements. J Clin Pharm Ther; 47(12):1952-1965. 
  • Ernest-Suarez K, et al. 2025. Live rotavirus vaccination appears low-risk in infants born to mothers with inflammatory bowel disease on biologics. Clin Gastroenterol Hepatol; 23(5):835-845. 
  • Gisbert JP, et al. 2023. Vaccines in children exposed to biological agents in utero and/or during breastfeeding: Are they effective and safe? J Crohns Colitis; 17 (6):995-1009. 
  • Gisbert JP, et al. 2020. Safety of new biologics (vedolizumab and ustekinumab) and small molecules (tofacitinib) during pregnancy: A review. Drugs; 80(11):1085-1100.  
  • Honap S, et al. 2023. An update on the safety of long-term vedolizumab use in inflammatory bowel disease. Expert Opin Drug Saf; 22 (9):767-776. 
  • Julsgaard M, et al. 2017. Vedolizumab safety in pregnancy and newborn outcomes. Gut; 66(10):1866-1867.  
  • Julsgaard M, et al. 2018. Vedolizumab concentrations in the breast milk of nursing mothers with inflammatory bowel disease. Gastroenterology; 154: 752-765.  
  • Lahat A, et al. 2018. Vedolizumab levels in breast milk of nursing mothers with inflammatory bowel disease. J Crohns Colitis; 12:120-3.  
  • Lamb CA, et al. 2019. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut; 68(Suppl 3):s1-s106.  
  • Laube R, et al. 2021. Use of medications during pregnancy and breastfeeding for Crohn’s disease and ulcerative colitis. Expert Opin Drug Saf; 20(3):275-292.  
  • Mahadevan U, et al. 2017. Vedolizumab exposure in pregnancy: Outcomes from clinical studies in inflammatory bowel disease. Aliment Pharmacol Ther; 45:941-950.  
  • Mahadevan U, et al. 2017. Editorial: vedolizumab in pregnancy – is gut selectivity as good for baby as it is for mum? Authors’ reply. Aliment Pharmacol Ther; 45(9):1284. 
  • Meyer A, et al. 2025. Safety of vedolizumab and ustekinumab compared with anti-TNF in pregnant women with inflammatory bowel disease. Clin Gastroenterol Hepatol; 23(1):144-153.e22. 
  • Mitrova K, et al. 2022. Safety of ustekinumab and vedolizumab during pregnancy-Pregnancy, neonatal, and infant outcome: A prospective multicentre study. J Crohn’s Colitis; 16(12):1808-1815. 
  • Moens A, et al. 2019. Outcome of pregnancies in female patients with inflammatory bowel diseases treated with vedolizumab. J Crohns Colitis; 13(1):12-13.  
  • Moens A, et al. 2020. Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study. Aliment Pharmacol Ther; 51(1):129-138.  
  • Nguyen B, et al. 2026. Safety of vedolizumab in pregnancy: An updated systematic review and comprehensive meta-analysis. Journal of Clinical Gastroenterology; 60(3):225-231. 
  • Nielsen OH. 2022. Biologics for inflammatory bowel disease and their safety in pregnancy: A systematic review and meta-analysis. Clin Gastroenterol Hepatol; 20(1):74-87. 
  • Pingeon O, et al. 2026. Safety of advanced therapies during pregnancy in women with immune-mediated inflammatory diseases: a systematic review and meta-analysis. J Crohns Colitis; 8;20(5):jjag045. 
  • Prentice R, et al. 2025. Vedolizumab and ustekinumab levels in pregnant women with inflammatory bowel disease and infants exposed in utero. Clin Gastroenterol Hepatol; 23(1):124-133.e7. 
  • Pugliese D, et al. 2024. New drugs for the treatment of IBD during conception, pregnancy, and lactation. Dig Liver Dis; 56(2):235-241. 
  • Rosario M, et al. 2017. A review of the clinical pharmacokinetics, pharmacodynamics, and immunogenicity of vedolizumab. Clin Pharmacokinet; 56(11): 1287–1301.  
  • Sheridan J, et al. 2017. Letter: Vedolizumab in Pregnancy. J Crohns Colitis; 11(8):1025-1026. 
  • Shitrit AB-G A, et al. 2019. Exposure to vedolizumab in IBD pregnant women appears of low risk for mother and neonate: A first perspective comparison study. Am J Gastroenterol; 114(7): 1172-1175.   
  • Sun W, et al. 2021. Vedolizumab concentrations in breast milk: Results from a prospective, postmarketing, milk-only lactation study in nursing mothers with inflammatory bowel disease. Clin Pharmacokinet; 60:811-8.  
  • Takeda Pharmaceuticals America, Inc. 2026. Entyvio product label. Available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e94621c-1a95-4af9-98d1-52b9e6f1949c  

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