The Basics
What is Vedolizumab?
Used to treat moderate to severe active ulcerative colitis (UC) and moderate to severe active Crohn’s disease (CD).
Brand names for Vedolizumab
Entyvio
How Vedolizumab is classified
Antibodies – Monoclonal (Humanized)
Vedolizumab During Pregnancy
Vedolizumab pregnancy category
Category Not AssignedNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Vedolizumab while pregnant
Available pharmacovigilance data, data from the ongoing pregnancy registry, and data from published case reports and cohort studies in pregnant women have not identified an ENTYVIO associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy (see Clinical Considerations). No fetal harm was observed in animal reproduction studies with intravenous administration of vedolizumab to rabbits and monkeys at dose levels 20 times the recommended human dosage (see Data). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and miscarriage is 15 to 20%, respectively. Clinical Considerations Disease-associated Maternal and Embryo/fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth. Fetal/Neonatal Adverse Reactions ENTYVIO administered during pregnancy could affect immune responses in the in utero exposed newborn and infant. The clinical significance of low levels of ENTYVIO in uteroexposed infants is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is unknown. Data Animal Data A reproduction study has been performed in pregnant rabbits at single intravenous doses up to 100 mg/kg administered on gestation Day 7 (about 20 times the recommended human dosage) and has revealed no evidence of impaired fertility or harm to the fetus due to vedolizumab. A pre-and post-natal development study in monkeys showed no evidence of any adverse effect on pre-and post-natal development at intravenous doses up to 100 mg/kg (about 20 times the recommended human dosage).
Taking Vedolizumab While Breastfeeding
What are recommendations for lactation if you're taking Vedolizumab?
Some information indicates that maternal vedolizumab injections appear to produce low levels in breastmilk and to not adversely affect the nursing infant. Because vedolizumab is a large protein molecule with a molecular weight of about 147,000, absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Most experts feel that the drug is probably safe during nursing.[1][2] Until more data become available, vedolizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
Maternal / infant drug levels
Some information indicates that maternal vedolizumab injections appear to produce low levels in breastmilk and to not adversely affect the nursing infant. Because vedolizumab is a large protein molecule with a molecular weight of about 147,000, absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Most experts feel that the drug is probably safe during nursing.[1][2] Until more data become available, vedolizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
Possible effects of Vedolizumab on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Vedolizumab
None listed
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Mahadevan U , Robinson C, Bernasko N et al. Inflammatory bowel disease in pregnancy clinical care pathway: A report from the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. 2019;156:1508-24. PMID: 30658060
2. Picardo S, Seow CH. A pharmacological approach to managing inflammatory bowel disease during conception, pregnancy and breastfeeding: Biologic and oral small molecule therapy. Drugs. 2019;79:1053-63. PMID: 31183768
3. Lahat A, Shitrit AB, Naftali T et al. Vedolizumab levels in breast milk of nursing mothers with inflammatory bowel disease. J Crohns Colitis. 2018;12:120-3. PMID: 28961712
4. Julsgaard M, Kjeldsen J, Bibby BM et al. Vedolizumab concentrations in the breast milk of nursing mothers with inflammatory bowel disease. Gastroenterology. 2018;154:752-4. PMID: 28988916
5. Moens A, Van Hoeve K, Humblet E et al. Outcome of pregnancies in female patients with inflammatory bowel diseases treated with vedolizumab. J Crohns Colitis. 2019;13:12-8. PMID: 30281093
6. Moens A, Van Der Woude CJ, Julsgaard M et al. Outcomes of pregnancy in IBD patients treated with vedolizumab, anti-TNF or conventional therapy. Gastroenterology. 2019;156:S633. Abstract Su1846.
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
