Last update June 9, 2026

Natalizumab

Compatible

Safe product and/or breastfeeding is the best option.

A humanised recombinant IgG4k monoclonal antibody that blocks the human integrin alpha-4 subunit, thereby impeding the passage of T cells through the meninges. Approved for use in the treatment of severe forms of multiple sclerosis (EMA 2017) and in Crohn’s disease refractory to other treatments (Yarur 2013, FDA 2012). Administered by intravenous infusion every 4 weeks.

Its very high molecular weight explains the minimal or no transfer into breast milk observed (Callegari 2023, Proschmann 2021, Ciplea 2020, Mahadevan 2019, Matro 2018, Proschmann 2018, Hainke 2015, Baker 2015), as molecules larger than 800–1,000 Da. have difficulty passing into breast milk. (Hale, Almas 2016, Anderson 2016)

No plasma levels have been detected in infants of treated mothers (Ciplea 2020) and no clinical, developmental or infectious problems, nor any vaccination-related complications, have been observed in these infants. (Witt 2026, Carrozzo 2025, Camilli 2025, Ciplea 2020, Mahadevan 2019)

Due to its protein nature, it is inactivated in the gastrointestinal tract and is not absorbed (oral bioavailability is practically zero), which hinders or prevents its passage into the infant’s plasma from ingested breast milk (Lactmed, Rademaker 2018, Bragnes 2017, Götestam 2016, Witzel 2014, Butler 2014, Mervic 2014, Cree 2013), except in preterm infants and during the immediate neonatal period, when there may be increased intestinal permeability (Sammaritano 2020). Waiting two weeks after delivery before resuming treatment allows the newborn’s plasma levels to fall from their pre-delivery levels and also minimises transmission to the baby. (Krysko 2023) 

Expert authors consider the use of this and other monoclonal antibodies during breastfeeding to be safe or very likely safe (Shipley 2025, Mahadevan 2025 & 2017, Sánchez 2023, Gklinos 2023, Ciplea 2020, Freedman 2020, Whittam 2019, Dobsosn 2019, Lamb 2019, Langer 2019, Matro 2018, Anderson 2018 and 2016, Almas 2016, Baker 2015, Briggs 2015, Damas 2015, Witzel 2014, Pistilli 2013, van der Woude 2010). Other authors prefer alternatives that are excreted in breast milk to a lesser extent. (Hoxha 2025, Alroughani 2016)


See below the information of these related products:

Alternatives

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.
DONATE NOW

Other names

Natalizumab is also known as


Natalizumab in other languages or writings:

Groups

Natalizumab belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Natalizumab in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 0 %
Molecular weight 149.000 daltons
VD 0.08 l/Kg
T½ 264 hours
M/P ratio 0.001 - 0.003 -
Theoretical Dose 0.14 (0.07 - 0.43) mg/Kg/d
Relative Dose 1.7 - 5.3 %

References

  1. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on April 16, 2024 Full text (link to original source)
  2. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  3. Witt L, Friedmann N, Haben S, Dost-Kovalsky K, Bast N, Oganowski T, Gold R, Thiel S, Hellwig K. Safety of breastfeeding under monoclonal antibodies in the offspring of mothers with multiple sclerosis or neuromyelitis optica spectrum disorder. J Neurol Neurosurg Psychiatry. 2026 May 14;97(6):522-531. Abstract
  4. Shipley J, Beharry J, Yeh W, Seery N, Foong YC, Ayton D, Siriratnam P, Tan T, Beadnall H, Barton J, Bridge F, Wesselingh R, Taylor L, Rath L, Haartsen J, Gadi M, Nesbitt C, Zhong M, Cushing V, McKay F, Morahan J, Trewin BP, et al. Consensus recommendations on multiple sclerosis management in Australia and New Zealand: part 2. Med J Aust. 2025 Apr 21;222(7):365-371. Abstract
  5. Hoxha T, Youssef M, Huang V, Tandon P. Inflammatory Bowel Disease and Breastfeeding: A Narrative Review. Inflamm Bowel Dis. 2025 Jan 6;31(1):210-219. Abstract
  6. Camilli F, Carrozzo G, Bandini A, Pinardi F, Lugaresi A. Maternal and neonatal outcomes of natalizumab and anti-CD20 monoclonal antibody exposure during pregnancy and lactation in multiple sclerosis. Mult Scler J 2025;31 (3 Suppl):1363–4. P 434. Full text (link to original source)
  7. Carrozzo G, Pinardi F, Lugaresi A. Long-term safety evaluation of natalizumab during pregnancy and lactation in patients with multiple sclerosis. Neurol Sci. 2025 Aug;46(8):3797-3802. Abstract
  8. Mahadevan U, Seow CH, Barnes EL, Chaparro M, Flanagan E, Friedman S, Julsgaard M, Kane S, Ng S, Torres J, Watermeyer G, Yamamoto-Furusho J, Robinson C, Fisher S, Anderson P, Gearry R, Duricova D, Dubinsky M, Long M; Global Consensus Group for Pregnancy and IBD. Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2025 Oct;23(11S):S1-S60. Abstract
  9. Sánchez-Velasco S, Midaglia L, Vidal-Jordana A, Castillo F, Horno R, Carreras E, Serrano B, Bosch M, Agustí A, Montalban X, Tintoré M. Fármacos modificadores de la enfermedad en la esclerosis múltiple durante la lactancia: revisión de la evidencia actual. Rev Neurol. 2023 Jan 1;76(1):21-30. Abstract Full text (link to original source)
  10. Callegari I, Schneider M, Aebischer V, Voortman MM, Proschmann U, Ziemssen T, Lindberg R, Fischer-Barnicol B, Khalil M, Kappos L, Kuhle J, Sanderson NSR, Derfuss T. Natalizumab in cerebrospinal fluid and breastmilk of patients with multiple sclerosis. Ther Adv Neurol Disord. 2023 Jan 30;16:17562864221150040. Abstract Full text (link to original source)
  11. Gklinos P, Dobson R. Monoclonal Antibodies in Pregnancy and Breastfeeding in Patients with Multiple Sclerosis: A Review and an Updated Clinical Guide. Pharmaceuticals (Basel). 2023 May 21;16(5). Abstract Full text (link to original source)
  12. Krysko KM, Dobson R, Alroughani R, Amato MP, Bove R, Ciplea AI, Fragoso Y, Houtchens M, Jokubaitis VG, Magyari M, Abdelnasser A, Padma V, Thiel S, Tintore M, Vukusic S, Hellwig K. Family planning considerations in people with multiple sclerosis. Lancet Neurol. 2023 Apr;22(4):350-366. Abstract
  13. Stratigakis A, Paty D, Zou P, Zhao Z, Li Y, Zhang T. A regression approach for assessing large molecular drug concentration in breast milk. Reprod Breed 2023;3:199-207. Full text (link to original source) Full text (in our servers)
  14. Proschmann U, Haase R, Inojosa H, Akgün K, Ziemssen T. Drug and Neurofilament Levels in Serum and Breastmilk of Women With Multiple Sclerosis Exposed to Natalizumab During Pregnancy and Lactation. Front Immunol. 2021 Aug 26;12:715195. Abstract Full text (link to original source)
  15. Ciplea AI, Langer-Gould A, de Vries A, Schaap T, Thiel S, Ringelstein M, Gold R, Hellwig K. Monoclonal antibody treatment during pregnancy and/or lactation in women with MS or neuromyelitis optica spectrum disorder. Neurol Neuroimmunol Neuroinflamm. 2020 Apr 23;7(4). pii: e723. Abstract Full text (link to original source)
  16. Sammaritano LR, Bermas BL, Chakravarty EE, Chambers C, Clowse MEB, Lockshin MD, Marder W, Guyatt G, Branch DW, Buyon J, Christopher-Stine L, Crow-Hercher R, Cush J, Druzin M, Kavanaugh A, Laskin CA, Plante L, Salmon J, Simard J, Somers EC, Steen V, Tedeschi SK, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 2020 Apr;72(4):529-556. Abstract Full text (link to original source)
  17. Freedman MS, Devonshire V, Duquette P, Giacomini PS, Giuliani F, Levin MC, Montalban X, Morrow SA, Oh J, Rotstein D, Yeh EA; Canadian MS Working Group. Treatment Optimization in Multiple Sclerosis: Canadian MS Working Group Recommendations. Can J Neurol Sci. 2020 Jul;47(4):437-455. Abstract Full text (link to original source)
  18. Lamb CA, Kennedy NA, Raine T, Hendy PA, Smith PJ, Limdi JK, Hayee B, Lomer MCE, Parkes GC, Selinger C, Barrett KJ, Davies RJ, Bennett C, Gittens S, Dunlop MG, Faiz O, Fraser A, Garrick V, Johnston PD, Parkes M, Sanderson J, Terry H; et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut. 2019 Dec;68(Suppl 3):s1-s106. Abstract Full text (link to original source)
  19. Whittam DH, Tallantyre EC, Jolles S, Huda S, Moots RJ, Kim HJ, Robertson NP, Cree BAC, Jacob A. Rituximab in neurological disease: principles, evidence and practice. Pract Neurol. 2019 Feb;19(1):5-20. Abstract Full text (link to original source) Full text (in our servers)
  20. Mahadevan U, Robinson C, Bernasko N, Boland B, Chambers C, Dubinsky M, Friedman S, Kane S, Manthey J, Sauberan J, Stone J, Jain R. Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway: A Report From the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. 2019 Apr;156(5):1508-1524. Abstract Full text (link to original source)
  21. Langer-Gould AM. Pregnancy and Family Planning in Multiple Sclerosis. Continuum (Minneap Minn). 2019 Jun;25(3):773-792. Abstract
  22. Dobson R, Dassan P, Roberts M, Giovannoni G, Nelson-Piercy C, Brex PA. UK consensus on pregnancy in multiple sclerosis: 'Association of British Neurologists' guidelines. Pract Neurol. 2019 Apr;19(2):106-114. Abstract Full text (link to original source)
  23. Rademaker M, Agnew K, Andrews M, Armour K, Baker C, Foley P, Frew J, Gebauer K, Gupta M, Kennedy D, Marshman G, Sullivan J. Psoriasis in those planning a family, pregnant or breast-feeding. The Australasian Psoriasis Collaboration. Australas J Dermatol. 2018 May;59(2):86-100. Abstract
  24. Matro R, Martin CF, Wolf D, Shah SA, Mahadevan U. Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development. Gastroenterology. 2018 Sep;155(3):696-704. Abstract Full text (link to original source) Full text (in our servers)
  25. Proschmann U, Thomas K, Thiel S, Hellwig K, Ziemssen T. Natalizumab during pregnancy and lactation. Mult Scler. 2018 Oct;24(12):1627-1634. Abstract
  26. Anderson PO. Drug Treatment of Rheumatoid Arthritis During Breastfeeding. Breastfeed Med. 2018 Nov;13(9):575-577. Abstract
  27. EMA. Natalizumab (Tysabri). Ficha técnica. 2017 Full text (in our servers)
  28. Mahadevan U, McConnell RA, Chambers CD. Drug Safety and Risk of Adverse Outcomes for Pregnant Patients With Inflammatory Bowel Disease. Gastroenterology. 2017 Feb;152(2):451-462.e2. Abstract
  29. EMA. Natalizumab (Tysabri). Drug Summary. 2017 Full text (in our servers)
  30. Bragnes Y, Boshuizen R, de Vries A, Lexberg Å, Østensen M. Low level of Rituximab in human breast milk in a patient treated during lactation. Rheumatology (Oxford). 2017 Jun 1;56(6):1047-1048. Abstract
  31. Almas S, Vance J, Baker T, Hale T. Management of Multiple Sclerosis in the Breastfeeding Mother. Mult Scler Int. 2016;2016:6527458. Abstract Full text (link to original source) Full text (in our servers)
  32. Götestam Skorpen C, Hoeltzenbein M, Tincani A, Fischer-Betz R, Elefant E, Chambers C, da Silva J, Nelson-Piercy C, Cetin I, Costedoat-Chalumeau N, Dolhain R, Förger F, Khamashta M, Ruiz-Irastorza G, Zink A, Vencovsky J, Cutolo M, Caeyers N, Zumbühl C, Østensen M. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016 May;75(5):795-810. Abstract Full text (link to original source) Full text (in our servers)
  33. Anderson PO. Monoclonal Antibodies. Breastfeed Med. 2016 Apr;11:100-1. Abstract
  34. Alroughani R, Altintas A, Al Jumah M, Sahraian M, Alsharoqi I, AlTahan A, Daif A, Dahdaleh M, Deleu D, Fernandez O, Grigoriadis N, Inshasi J, Karabudak R, Taha K, Totolyan N, Yamout BI, Zakaria M, Bohlega S. Pregnancy and the Use of Disease-Modifying Therapies in Patients with Multiple Sclerosis: Benefits versus Risks. Mult Scler Int. 2016 Abstract Full text (link to original source) Full text (in our servers)
  35. Baker TE, Cooper SD, Kessler L, Hale TW. Transfer of natalizumab into breast milk in a mother with multiple sclerosis. J Hum Lact. 2015 Abstract
  36. Damas OM, Deshpande AR, Avalos DJ, Abreu MT. Treating Inflammatory Bowel Disease in Pregnancy: The Issues We Face Today. J Crohns Colitis. 2015 Oct;9(10):928-36. Abstract Full text (link to original source) Full text (in our servers)
  37. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  38. Hainke U, Sehr T, Eisele JC, Thomas K, Ziemssen T. Natalizumab: Passage into breast milk and neonatal blood. Mult Scler. 2015;23:690. Abstract EP1324 2015 Full text (link to original source) Full text (in our servers)
  39. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014 Mar;70(3):417.e1-10; quiz 427. Abstract
  40. Mervic L. Management of moderate to severe plaque psoriasis in pregnancy and lactation in the era of biologics. Acta Dermatovenerol Alp Pannonica Adriat. 2014;23(2):27-31. Abstract Full text (link to original source) Full text (in our servers)
  41. Witzel SJ. Lactation and the use of biologic immunosuppressive medications. Breastfeed Med. 2014 Dec;9(10):543-6. Abstract Full text (link to original source) Full text (in our servers)
  42. Pistilli B, Bellettini G, Giovannetti E, Codacci-Pisanelli G, Azim HA Jr, Benedetti G, Sarno MA, Peccatori FA. Chemotherapy, targeted agents, antiemetics and growth-factors in human milk: how should we counsel cancer patients about breastfeeding? Cancer Treat Rev. 2013 May;39(3):207-11. Abstract
  43. Yarur A, Kane SV. Update on pregnancy and breastfeeding in the era of biologics. Dig Liver Dis. 2013 Oct;45(10):787-94. Abstract Full text (link to original source) Full text (in our servers)
  44. Cree BA. Update on reproductive safety of current and emerging disease-modifying therapies for multiple sclerosis. Mult Scler. 2013 Jun;19(7):835-43. Abstract Full text (link to original source) Full text (in our servers)
  45. van der Woude CJ, Kolacek S, Dotan I, Oresland T, Vermeire S, Munkholm P, Mahadevan U, Mackillop L, Dignass A; European Crohn's Colitis Organisation (ECCO). European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohns Colitis. 2010 Abstract Full text (link to original source) Full text (in our servers)

Total visits

20,899

Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write us at elactancia.org@gmail.com

e-lactancia is a resource recommended by Instituto de Salud Infantil, Grecia-Institute of Child´s Health in Greece

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM