Summary of Use during Lactation

No information is available on the clinical use of ublituximab during breastfeeding. Because ublituximab is a large protein molecule with a molecular weight of 147,000 Da, the amount in milk is likely to be very low.[1] It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[2] Until more data become available, ublituximab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[3]

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1.

Stratigakis A, Paty D, Zou P, et al. A regression approach for assessing large molecular drug concentration in breast milk. Reprod Breed 2023;3:199-207. doi:10.1016/j.repbre.2023.10.003 [CrossRef]

2.

Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med 2021;16:591-3. [PubMed: 33956488]

3.

Krysko KM, Dobson R, Alroughani R, et al. Family planning considerations in people with multiple sclerosis. Lancet Neurol 2023;22:350-66. [PubMed: 36931808]

Substance Name

Ublituximab

CAS Registry Number

1174014-05-1

Drug Class

Breast Feeding

Lactation

Milk, Human

Antineoplastic Agents

Antibodies, Monoclonal