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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. PMID: 34110640 DOI: 10.1111/jgh.15574
  • Caballero-Mateos AM, et al. 2023. IBD and Motherhood: A Journey through Conception, Pregnancy and Beyond. J Clin Med. 12(19):6192.
  • Chugh R. 2023. Maternal and Neonatal Outcomes in Vedolizumab and Ustekinumab Exposed Pregnancies: Results from the PIANO registry. Am J Gastroenterol. DOI: 10.14309/ajg.0000000000002553.
  • 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.
  • 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. PMID: 32562207 DOI: 10.1007/s40265-020-01346-4
  • 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. PMID: 31562236 PMCID: PMC6872448 DOI: 10.1136/gutjnl-2019-318484
  • 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. PMID: 33412078 DOI: 10.1080/14740338.2021.1873948
  • 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. 2024. Safety of Vedolizumab and Ustekinumab Compared With Anti-TNF in Pregnant Women With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. DOI: 10.1016/j.cgh.2023.12.029.
  • Mitrova K, et al. 2022. Safety of Ustekinumab and Vedolizumab During Pregnancy-Pregnancy, Neonatal, and Infant Outcome: A Prospective Multicentre Study. Journal of Crohn’s & colitis. Vol 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.
  • 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.
  • 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. 2017; 56(11): 1287–1301. PMCID: PMC5648740 PMID: 28523450
  • 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. 2018. Entyvio product label. Available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e94621c-1a95-4af9-98d1-52b9e6f1949c

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