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.[1] It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[2] Ofatumumab appears to be acceptable to use during breastfeeding.[3] Breastfeeding can resume after the injection; however, waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[4]
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
The German Multiple Sclerosis and Pregnancy Registry reported 4 cases with of mothers who were taking ofatumumab while breastfeeding. No infant B-cell counts taken between 13 and 190 days after initiation of exposed breastfeeding showed values below the lower limit.[5]
Two infants whose mothers were taking ofatumumab only during breastfeeding were identified in the German neuroimmunologic pregnancy registry. Their B-cell counts at 209 to 609 days postpartum were normal.[6] One of these infants had been previously reported.[5]
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.
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]
4.
Krysko KM, Dobson R, Alroughani R, et al. Family planning considerations in people with multiple sclerosis. Lancet Neurol 2023;22:350-66 [PubMed: 36931808]
5.
Ciplea A, Witt L, Thiel S, et al. Ofatumumab in breast milk of multiple sclerosis patients. Mult Scler J 2023;29 (3_Suppl):132-3.doi:10.1177/1352458523 [CrossRef]
6.
Schwake C, Steinle J, Thiel S, et al. Neonatal B-cell levels and infant health in newborns potentially exposed to anti-CD20 monoclonal antibodies during pregnancy or lactation. Neurol Neuroimmunol Neuroinflamm 2024;11:e200264 [PMC free article: PMC11178251] [PubMed: 38870458]
Substance Identification
Substance Name
Ofatumumab
CAS Registry Number
679818-59-8
Drug Class
Breast Feeding
Lactation
Milk, Human
Antibodies, Monoclonal
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