Last update March 5, 2021
Very Low Risk
IgG1-human monoclonal antibody directed against tumor necrosis factor used for treatment of auto-immune diseases like rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and uveitis.
Adalimumab is administered every other week via subcutaneous injection.
It is excreted in breast milk in clinically insignificant amounts (Matro 2018, Fritzsche 2012, Ben-Horn 2010) and no problems have been observed in infants whose mothers have taken it (Matro 2018, Dall'ara 2016, Julsgaard 2013, Fritzsche 2012, Mishkin 2006, Mahadevan 2006, Vesga 2005). Plasma levels in these infants were very low (Julsgaard 2013, Fritzsche 2012).
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, 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).
It may be advisable to avoid its use in the first post-partum week since pass of significant amounts of IgG to the milk can occur in the first 3 - 4 post-partum days. A case of early congenital neutropenia has been published in a newborn whose mother was taking adalimumab for Crohn's disease and isoniazid for tuberculosis (van den Broek 2018).
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).
The manufacturer (Amgen 2017, EMA 2010) consider the use of this medication to be safe during breastfeeding.
Several medical societies, experts and expert consensus, consider that the use of this medication during breastfeeding is safe or very likely to be safe (Hale, Owczarek 2020, Sammaritano 2020 y 2014, Lamb 2019, Mahadevan 2019 y 2013, Picardo 2019, Amin 2018, Briggs 2015, Nguyen 2016, Flint 2016, McConnell 2016, Gotestam 2016, Huang 2016 y 2014, Grunewald 2015, Damas 2015, van der Woude 2015 y 2010, Nielsen 2014, Witzel 2014, Butler 2014, Schulze 2014, Yarur 2013, Bae 2012, Fischer 2010).
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.
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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