Last update May 26, 2022
Decreased level of risk
New scientific evidences have driven the Apilam staff to update the level of risk associated to this product.
Former level of risk, which was Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment., is now set to Safe. Compatible. Minimal risk for breastfeeding and infant.
Level of risk reviewed on May 26, 2022
Very Low Risk
A recombinant humanized anti-CD20 monoclonal antibody that reduces the number and function of B-lymphocytes that express CD20. Indicated in progressive primary multiple sclerosis (EMA 2018). Intravenous administration. One dose on day 1 and day 15 and then every 6 months.
It is excreted in breast milk in undetectable or negligible amounts, clinically insignificant. (Anderson 2022)
No problems have been observed in infants of mothers treated with ocrelizumab, except for one case of a slight and transient decrease in B cells and one otitis-conjunctivitis. (Anderson 2022, Ciplea 2020, Oreja 2019)
It´s very high molecular weight (> 100,000 Da) makes it very unlikely to pass into breast milk in a significant quantity, since molecules of more than 800 - 1,000 Da do not pass into breast milk. (Hale, Almas 2016, Anderson 2016)
Null or negligible passage into breast milk of similar monoclonal antibodies, such as adalimumab, belimumab, certolizumab, golimumab, infliximab, ipilimumab, natalizumab, rituximab, tocilizumab and ustekinumab has been confirmed. (Bar-Gil 2021, LaHue 2020, Ciplea 2020, Saito 2020, 2019 and 2018, Krysko 2019, Whittam 2019, Klenske 2019, Matro 2018, Anderson 2018, Bragnes 2017, Witzel 2014, Ross 2014, 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, 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 y 2018, Klenske 2019, Mugheddu 2019, Krysko 2019, Matro 2018, Bragnes 2017, Hyrich 2014, Danve 2014)
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 y 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)
It is advisable to monitor the plasma levels of B cells of infants whose mothers were exposed to Ocrelizumab during pregnancy and to delay vaccination with living organisms until normal B cell levels have been recovered. (EMA 2018)
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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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