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MotherToBaby

Medications and More during pregnancy and breastfeeding

Ofatumumab (Kesimpta®, Arzerra®)

Selected References:

  • Anderson PO. 2021. Monoclonal antibodies during breastfeeding. Breastfeeding Med.16(8):591-593.  
  • Bellot M, et al. 2022. Effect of ofatumumab on pregnancy, parturition, and lactation in cynomolgus monkeys. Reprod Toxicol. 108:28-34.  
  • Ciplea A, et al. 2023. Ofatumumab in breast milk of multiple sclerosis patients. Mult Scler J. ;29 (3_Suppl):132-3.  
  • Dobson R, et al. 2023. Anti-CD20 therapies in pregnancy and breast feeding: a review and ABN guidelines. Pract Neurol. 23(1):6-14. . 
  • Gklinos P, Dobson R. 2023. Monoclonal Antibodies in Pregnancy and Breastfeeding in Patients with Multiple Sclerosis: A Review and an Updated Clinical Guide. Pharmaceuticals (Basel). 16(5):770. doi: 10.3390/ph16050770. PMID: 37242553; PMCID: PMC10223026. 
  • Hauser SL, et al. 2022. Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years. Mult Scler. 2022 Sep;28(10):1576-1590.  
  • Hefner S, et al. 2025. Impact of continuous ofatumumab exposure during pregnancy in multiple sclerosis. Neurol Clin Pract 15(1): e200410.  
  • Hellwig K, et al. 2022. Pregnancy outcomes in patients with multiple sclerosis following exposure to ofatumumab (P4-4.007). Neurology. Neurology, 98 (18 Supplement) 3377.  
  • Krajnc N, et al. 2022. Monoclonal Antibodies in the Treatment of Relapsing Multiple Sclerosis: an Overview with Emphasis on Pregnancy, Vaccination, and Risk Management. Neurotherapeutics. 19(3):753-773.  
  • Krysko KM, et al. 2023. Family planning considerations in people with multiple sclerosis. Lancet Neurol. 22(4):350-366.  
  • Novartis Pharmaceuticals Corporation. 2022. Kesimpta® (ofatumumab) Prescribing Information. Available online at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a8a3f53-2062-48ff-9dbe-b939df133ca3&audience=consumer  
  • Novartis Pharmaceuticals Corporation. 2022. Arzerra® (ofatumumab) Prescribing Information. Available online at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=77785ce3-e8df-4ca1-8f8e-6c418c6a17de&audience=consumer  
  • Quattrocchi E, Ostergaard M, Taylor PC, van Vollenhoven RF, Chu M, Mallett S, Perry H, Kurrasch R. 2016. Safety of repeated open-label treatment courses of intravenous ofatumumab, a human anti-cd20 monoclonal antibody, in rheumatoid arthritis: Results from three clinical trials. PLoS One. Jun 23;11(6): e0157961.  
  • Schwake C, et al.2022. 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.  28 (3 Suppl):29-30.  
  • Witt L, et al. 2025. Ofatumumab-exposed breastfeeding in multiple sclerosis patients. Mult Scler. 31(3):338-351.  

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