Ublituximab

Ublituximab is a recombinant anti-CD20 monoclonal antibody used to treat relapsing forms of multiple sclerosis. It is administered by intravenous infusion, with an initial dose, another dose two weeks later, and then every 24 weeks. The premedication administered beforehand to alleviate possible side effects, a corticosteroid, an antihistamine and an antipyretic, is compatible with breastfeeding.

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

Its very high molecular weight (>100,000 Da) makes it highly unlikely that it will pass into breast milk in significant quantities, as molecules larger than 800-1,000 Da do not pass into breast milk. ^{(Stratigakis 2023, Gklinos 2023, 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 ^{(Gklinos 2023, Anderson 2021)}, except in premature babies and the immediate neonatal period, when there may be greater intestinal permeability. ^{(Sammaritano 2020)}

According to the manufacturer: "Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. Afterwards, ublituximab could be used during breast-feeding if clinically needed." ^{(EMA 2023).} Expert authors advise waiting at least two weeks after giving birth before resuming treatment. ^{(Krysko 2023)}

See below the information of this related product:

• Maternal Multiple Sclerosis (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)