Last update March 11, 2022
Very Low Risk
IgG1 monoclonal-antibody against tumor necrosis alpha factor (TNFα) which is used to treat autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis. Intravenous administration, initial dose, at 2 and 6 weeks and every 8 weeks
Its pharmacokinetic data (very high molecular weight and high binding to plasma proteins) explain the excretion in breast milk in undetectable amount (Mahadevan 2005, Vasiliauskas 2006, Stengel 2008, Kane 2009) or clinically non-significant. (Matro 2018, Glosen 2014, Fritzsche 2012, Ben-Horn 2011)
Plasma levels of infants breastfed by mothers who were treated with Infliximab have resulted to be undetectable or very low. (Vasiliauskas 2006, Kane 2009, Fritzsche 2012, Steenholdt 2012)
Neither short nor long-term adverse effects on development, immunological response and/or infection rate, nor altered response to vaccination of infants whose mothers were taking Infliximab have been observed. (Mahadevan 2005, Vasiliauskas 2006, Stengel 2008, Kane 2009, Tursi 2010, Puig 2010, Correia 2010 , Fritzsche 2012, Steenholdt 2012)
Because it lacks of oral bioavailability, seems difficult any pass to the infant’s plasma through the ingested breastmilk (Amin 2018, Bae 2012), except on premature infants and immediate neonatal period, in which there may be an increased intestinal permeability.
Numerous experts and scientific societies of Rheumatology, Gastroenterology and Dermatology consider it to be a very low risk drug, and therefore, compatible while breastfeeding. (Sammaritano 2020, Mahadevan 2019 y 2015, Anderson 2019, Picardo 2019, Matro 2018, Amin 2018, Briggs 2017, Nguyen 2016, Flint 2016, Gotestam 2016, van der Houde 2015, Nielsen 2014, Hyrich 2014, Mahadevan 2011)
Some agencies recommend against administering live vaccines to infants while the mother is receiving infliximab unless the infant's serum levels of infliximab are undetectable. (AEMPS 2022)
We do not have alternatives for L04AB02 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.
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Thank you for helping to protect and promote breastfeeding.
e-lactancia is a resource recommended by Academy of Breastfeeding Medicine - 2012 of United States of America
Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM