阿仑珠单抗

A humanised monoclonal antibody derived from recombinant DNA with a specific immunosuppressive effect. Indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS) ^{(Almas 2016)} and chronic lymphocytic leukaemia (CLL) ^{(Mould 2007)}. Intravenous administration. One daily dose for 5 days, repeated annually (RRMS). One daily dose initially, followed by three times weekly for 12 weeks (CLL).

As of the last update, we found no published data on its excretion into breast milk.

Its extremely high molecular weight (>100,000 Da) makes it highly unlikely to pass into milk in significant quantities, as molecules larger than 800–1,000 Da have difficulty being excreted into breast milk. ^{(Hale, Almas 2016, Anderson 2016)}

Due to its protein nature, it is inactivated in the gastrointestinal tract and is not absorbed (oral bioavailability is practically zero), which hinders or prevents its passage into the infant’s plasma from ingested breast milk (Lactmed, Hale, Anderson 2021), except in preterm infants and during the immediate neonatal period, when there may be greater intestinal permeability ^{(Sammaritano 2020}). Waiting two weeks after delivery before resuming treatment allows the newborn’s plasma levels to fall from their pre-delivery levels and also minimises transmission to the baby. ^{(Krysko 2023)} 

Until further published data on this medicine in relation to breastfeeding becomes available, safer, well-established alternatives are preferable, particularly during the neonatal period and in cases of prematurity. ^{(Gklinos 2023, Iyer 2023, Krysko 2023, Varytė 2021, Alroughani 2020, Langer 2019, Bove 2014, Cree 2013)}

No or negligible transfer into breast milk has been observed for other similar monoclonal antibodies, and no problems have been detected in infants whose mothers were receiving them.

Expert authors consider the use of monoclonal antibodies during breastfeeding to be safe or very likely safe. ^{(Hale, LaHue 2020, Whittam 2019, Matro 2018, Anderson 2018 and 2016, Witzel 2014, Pistilli 2013)}

Given the strong evidence regarding the benefits of breastfeeding for infants’ development and mothers’ health, it is advisable to assess the risk-benefit balance of any maternal treatment, including chemotherapy, by providing individual advice to each mother who wishes to continue breastfeeding. ^{(Koren 2013)}

See below the information of these related products:

• Maternal Cancer; Maternal Neoplasia (Unsafe. Moderate/severe adverse effects. Compatible under certain circumstances. Follow-up recommended. Use safer alternative or discontinue breastfeeding from 5 to 7 T ½ . Read Commentary.)
• Maternal Multiple Sclerosis (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)

See below the information of this related group:

• NoATC FAR-L: Monoclonal antibodies