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MotherToBaby

Medications and More during pregnancy and breastfeeding

Natalizumab

Selected References:

  • Andersen JB, et al. 2023. Pregnancy outcomes after early fetal exposure to injectable first-line treatments, dimethyl fumarate, or natalizumab in Danish women with multiple sclerosis. European journal of neurology; 30(1), 162–171. 
  • Bast N, et al. 2024. Impact of disease-modifying therapies on pregnancy outcomes in multiple sclerosis: a prospective cohort study from the German multiple sclerosis and pregnancy registry. Lancet Reg Health Eur; 48: 101137.  
  • Ciplea AI, et al. 2020. Exposure to natalizumab during pregnancy and lactation is safe -Commentary. Multiple sclerosis (Houndmills, Basingstoke, England); 26(8), 892–893. 
  • D’Amico E, et al. 2021. Male fertility in relapsing-remitting multiple sclerosis patients treated with natalizumab and ocrelizumab: A prospective case-control study. Multiple sclerosis (Houndmills, Basingstoke, England); 27(14), 2284–2287. 
  • Demortiere S, et al. 2021. Maintenance of natalizumab during the first trimester of pregnancy in active multiple sclerosis. Mult Scler; 27(5):712-718. 
  • Ebrahimi N, et al. 2015. Pregnancy and fetal outcomes following natalizumab exposure in pregnancy. A prospective, controlled observational study. Mult Scler; 21(2):198-205. 
  • Friend S, et al. 2016. Evaluation of pregnancy outcomes from the Tysabri (natalizumab) pregnancy exposure registry: a global, observational, follow-up study. BMC Neurol; 16(1):150 
  • Gklinos P, et al. 2023. Monoclonal Antibodies in Pregnancy and Breastfeeding in Patients with Multiple Sclerosis: A Review and an Updated Clinical Guide.Pharmaceuticals (Basel, Switzerland); 16(5),770. 
  • Godano E, et al. 2021. Erythropoietin therapy in a case of neonatal anemia after exposure to natalizumab throughout pregnancy. Ital J Pediatr; 47, 69. 
  • Guilloton L, et al. 2017. Neonatal pancytopenia in a child, born after maternal exposure to natalizumab throughout pregnancy. J Gynecol Obstet Hum Reprod; 46(3): 301-302. 
  • Haghikia A, et al. 2014. Natalizumab use during the third trimester of pregnancy. JAMA Neurol; 71(7): 891-895. 
  • Krysko KM, et al. 2023. Family planning considerations in people with multiple sclerosis. Lancet Neurol; 2023;22:350–66. 
  • Landi D, et al. 2022. Exposure to natalizumab throughout pregnancy: effectiveness and safety in an Italian cohort of women with multiple sclerosis. J Neurol Neurosurg Psychiatry jnnp-2022-329657.  
  • Mahadevan U, et al. 2019. Inflammatory bowel disease in pregnancy clinical care pathway: a report from the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology; 156(5):1508-1524. 
  • Mahadevan U, et al. 2023. Global consensus statement on the management of pregnancy in inflammatory bowel disease. Clin Gastroenterol Hepatol 2025;23(Suppl 11):S1–S60. 
  • Matro R, et al. 2018. Exposure concentrations of infants breastfed by women receiving biologic therapies for inflammatory bowel diseases and effects of breastfeeding on infections and development. Gastroenterology; 155:696–704. 
  • Massarotti C, et al. 2021. Effect of Multiple Sclerosis and Its Treatments on Male Fertility: Cues for Future Research. Journal of clinical medicine; 10(22), 5401 
  • O’Leary S, et al. 2023. Practical Clinical Guidelines for Natalizumab Treatment in Patients With Relapsing Multiple Sclerosis. Journal of infusion nursing: the official publication of the Infusion Nurses Society; 46(6), 347–359. 
  • Oreja-Guevara C, et al. 2023. Family Planning in Fertile-Age Patients With Multiple Sclerosis (MS) (ConPlanEM Study): Delphi Consensus Statements. Cureus; 15(8), e44056 
  • Peng A, et al. 2018. Natalizumab exposure during pregnancy in multiple sclerosis: a systematic review. J Neurol Sci; 396:202-205.  
  • Portaccio E, et al. 2018. Pregnancy decision-making in women with multiple sclerosis treated with natalizumab: I: Fetal risks. Neurology; 90(10), e823–e831. 
  • Portaccio E, et al. 2022. Natalizumab treatment and pregnancy in multiple sclerosis: A reappraisal of maternal and infant outcomes after 6 years. Mult Scler; 28(13):2137-2141.  
  • Simone IL, et al. 2021. Influence of Pregnancy in Multiple Sclerosis and Impact of Disease-Modifying Therapies. Frontiers in neurology; 12, 697974. 
  • Ramesh V, et al. 2022. Adverse Obstetric Outcomes in Pregnant Women Using Natalizumab for the Treatment of Multiple Sclerosis: A Systematic Review. Cureus; 14(10), e29952 
  • Shipley J, et al. 2025. Consensus recommendations on multiple sclerosis management in Australia and New Zealand: part 2. Med J Aust; 222:365–71. 
  • Siracusano M, et al. 2025. Maternal multiple sclerosis and offspring’s developmental and behavioral profile: a case-control study. Curr Neuropharmacol; doi: 10.2174/011570159X370866250416103923. Epub ahead of print.   
  • Thiel S, et al. 2024. Disease activity and neonatal outcomes after exposure to natalizumab throughout pregnancy. J Neurol Neurosurg Psychiatry; 95(6): 561-570. 
  • U.S. Food and Drug Administration. 2025. Tysabri (natalizumab) injection, for intravenous use: Prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125104s984lbl.pdf 
  • Yeh WZ, et al. 2021. MSBase Study Group. Natalizumab, fingolimod and dimethyl fumarate use and pregnancy-related relapse and disability in women with multiple sclerosis. Neurology; 96(24):e2989-3002. 

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