Last update Feb. 25, 2021
Very Low Risk
Humanized recombinant IgG1 monoclonal antibody that blocks the α4β7 integrin of T lymphocytes that migrate to the intestine.
It acts as a biological immunosuppressant specific to the intestine.
Indicated in the treatment of ulcerative colitis and Crohn's disease when unresponsive to other treatments.
Its possible side effects are relatively benign: upper respiratory tract infections with or without fever, fatigue and headaches or joint pain.
Administration by intravenous infusion at weeks 0, 2, 6 and then every 8 weeks (AEMPS-EMA-Takeda 2018).
Its very high molecular weight explains the small transfer to milk observed (Sun 2021, Lahat 2018, Julsgaard 2018).
No problems have been observed in infants of mothers treated with this drug (Sun 2021, Moens 2020 and 2019, Lahat 2018, Julsgaard 2018).
Due to its protein nature, it is inactivated in the gastrointestinal tract without being absorbed (practically nil oral bioavailability) and this hinders or prevents its passage into the infant´s plasma from ingested breast milk (Lactmed, Rademaker 2018, Bragnes 2017, Götestam 2016 , Witzel 2014, Butler 2014, Mervic 2014) except for premature infants and during the immediate neonatal period when there might be a greater intestinal permeability (Sammaritano 2020).
No problems have been detected in infants whose mothers received other similar monoclonal antibodies such as belimumab, bevacizumab, infliximab, rituximab, tocilizumab, or ustekinumab (Bar-Gil 2021, LaHue 2020, Saito 2020, 2019 and 2018, Klenske 2019, Mugheddu 2019, Krysko 2019, Matro 2018, Bragnes 2017, Hyrich 2014, Danve 2014).
Several medical associations, experts and expert consensus consider the use of this medication to be probably compatible with breastfeeding (Hale 2019 p776, Matro 2018, Briggs 2017, Mahadevan 2017, McConnell 2016, Mahadevan 2015).
Expert authors consider that the use of monoclonal antibodies during breastfeeding is safe or very likely to be safe (Whittam 2019, Matro 2018, Anderson 2018 and 2016, Witzel 2014, Pistilli 2013).
Given the strong evidence that exists on the benefits of breastfeeding and the development of babies and the health of their mothers, it might be appropriate to evaluate the risk-benefit of any maternal treatment, including chemotherapy, and counsel individually each mother who wishes to continue breastfeeding (Koren 2013).
We do not have alternatives for Vedolizumab since it is relatively safe.
Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.
Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.
Thank you for helping to protect and promote breastfeeding.
e-lactancia is a resource recommended by Asociación Española de Bancos de Leche Humana of Spain
Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM