Evolocumab

Evolocumab is a human monoclonal antibody that binds to and blocks a protease (PCSK9) that regulates plasma levels of low-density lipoprotein cholesterol (LDL-C), leading to a decrease in plasma LDL cholesterol concentrations. Subcutaneous administration every two to four weeks.

At the time of the last update, we found no published data on its excretion in breast milk.

Its very high molecular weight (>100,000 Da) makes passage into milk in significant quantity very unlikely, as molecules larger than 800 - 1,000 Da do not pass into breast milk ^{(Hale, Almas 2016, Anderson 2021 and 2016)}. Null or negligible passage into breast milk of this and most other monoclonal antibodies and Fc fusion proteins has been proven or calculated and predicted.^{(Stratigakis 2023).}

Because of its protein nature it is inactivated in the gastrointestinal tract, not being absorbed, (virtually zero oral bioavailability), which hinders or prevents passage to infant plasma from ingested breast milk ^{(Lactmed, Anderson 2021, Rademaker 2018, Bragnes 2017, Götestam 2016, Witzel 2014)} except in preterm and immediate neonatal period, in which there may be higher intestinal permeability ^{(Sammaritano 2020)}, so it is recommended to start administering it from day 15 postpartum. ^{(Krysko 2023)}

Expert authors consider safe or very probably safe the use of monoclonal antibodies during lactation ^{(Matro 2018, Anderson 2021, 2018 and 2016, Witzel 2014, Pistilli 2013)}. Given the strong evidence for the benefits of breastfeeding for infant development and maternal health, it is appropriate to assess the risk-benefit of any maternal treatment, with individual counseling for each mother who wishes to continue breastfeeding. ^{(Koren 2013)}

For considerations on the appropriateness of lipid-lowering treatment during lactation see Maternal hyperlipidemia, hypercholesterolemia, hypertriglyceridemia.

See below the information of this related product:

• Maternal Hyperlipidemia, Hypercholesterolemia, Hypertriglyceridemia (Safe product and/or breastfeeding is the best option.)