Summary of Use during Lactation

Minimal information on the clinical use of ofatumumab during breastfeeding indicates that the drug has no effect on the immunity of the infants. Because ofatumumab is a large protein molecule with a molecular weight of 149,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Ofatumumab appears to be acceptable to use during breastfeeding;[1] however, waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[2] No other precautions appear to be required during breastfeeding while using ofatumumab. Breastfeeding can resume after the injection.[2]

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

Exposure of two infants to ofatumumab in breastmilk when their mothers were being treated for multiple sclerosis caused no effect on their infants’ B-cell counts.[3]

Effects on Lactation and Breastmilk

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

References

1.

Dobson R, Rog D, Ovadia C, et al. Anti-CD20 therapies in pregnancy and breast feeding: A review and ABN guidelines. Pract Neurol. 2022;23:6–14. [PubMed: 35803727]

2.

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

3.

Schwake C, Steinle J, Thiel S, et al. Effects of anti-CD20 therapies on infant health and physiological B-cell development if administered before or during pregnancy and/or lactation. Mult Scler J 2022;28 (3 Suppl):29-30 [Abstract]. doi: 10.1177/13524585221123. [CrossRef]

Substance Name

Ofatumumab

CAS Registry Number

679818-59-8

Drug Class

Breast Feeding

Lactation

Milk, Human

Antibodies, Monoclonal