Last update Nov. 6, 2022


Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

It is a recombinant humanized IgG1 anti-immunoglobulin E (IgE) monoclonal antibody. It is an immunoglobulin G (IgG) of huge molecular weight that binds with great affinity to IgE, blocking it, forming IgG-IgE complexes of even larger size and molecular weight. It is indicated in the prophylaxis of severe persistent asthma and in the treatment of chronic urticaria. Its use is authorized in children from 6 years of age (EMA 2016, Pediamecum 2015). Subcutaneous administration every 2 to 4 weeks.

Its very high molecular weight explains the negligible or null passage into breast milk observed. (Saito 2020), since molecules of more than 500 - 1,000 Da do not pass into breast milk. (Hale, Almas 2016, Anderson 2016)

No problems have been observed in infants whose mothers have taken it. (Losappio 2020, López 2019, Ensina 2017, González 2017)

Due to its protein nature, it is inactivated in the gastrointestinal tract, not being absorbed (practically zero oral bioavailability), which makes it difficult or prevents the passage to the infant's plasma from ingested breast milk, except in premature infants and the immediate neonatal period, when there may be greater intestinal permeability.

Several medical societies, experts authors and expert consensus, consider the use of this medication to be safe or very probably safe during breastfeeding. (Hale, Lactmed, Türk 2020, Middleton 2020, Whittam 2019, Matro 2018, Anderson 2018 y 2016, Witzel 2014, Pistilli 2013)


We do not have alternatives for Omalizumab since it is relatively safe.

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.

Other names

Omalizumab is also known as

Omalizumab in other languages or writings:


Main tradenames from several countries containing Omalizumab in its composition:


Variable Value Unit
Oral Bioavail. 0 (Subcut: 62) %
Molecular weight 149.000 daltons
VD 0.08 l/Kg
Tmax 168 - 192 hours
624 hours
Theoretical Dose 0.0003 -0.001 mg/Kg/d


  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from Consulted on March 17, 2022 Full text (link to original source)
  2. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: 2006 - Consulted on March 15, 2022 Full text (link to original source)
  3. Losappio LM, Mirone C, Schroeder JW, Scibilia J, Balossi L, Pastorello EA. Omalizumab Use in Chronic Spontaneous Urticaria during Pregnancy and a Four Years' Follow-Up: A Case Report. Case Rep Dermatol. 2020 Oct 8;12(3):174-177. Abstract
  4. Krysko KM, LaHue SC, Anderson A, Rutatangwa A, Rowles W, Schubert RD, Marcus J, Riley CS, Bevan C, Hale TW, Bove R. Minimal breast milk transfer of rituximab, a monoclonal antibody used in neurological conditions. Neurol Neuroimmunol Neuroinflamm. 2019 Nov 12;7(1). pii: e637. Abstract Full text (link to original source) Full text (in our servers)
  5. Türk M, Carneiro-Leão L, Kolkhir P, Bonnekoh H, Buttgereit T, Maurer M. How to Treat Patients with Chronic Spontaneous Urticaria with Omalizumab: Questions and Answers. J Allergy Clin Immunol Pract. 2020 Jan;8(1):113-124. Abstract
  6. Middleton PG, Gade EJ, Aguilera C, MacKillop L, Button BM, Coleman C, Johnson B, Albrechtsen C, Edenborough F, Rigau D, Gibson PG, Backer V. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J. 2020 Feb 6;55(2). pii: 1901208. Abstract Full text (link to original source) Full text (in our servers)
  7. Saito J, Yakuwa N, Sandaiji N, Uno C, Yagishita S, Suzuki T, Ozawa K, Kamura S, Yamatani A, Wada S, Sago H, Murashima A. Omalizumab concentrations in pregnancy and lactation: A case study. J Allergy Clin Immunol Pract. 2020 Nov - Dec;8(10):3603-3604. Abstract
  8. López Leon, S, Kaufman DG, Howard M, et al. Safety outcomes among infants exposed to omalizumab via breastfeeding: Results from the Xolair Pregnancy Registry (Expect). Abstracts of the 35th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Pennsylvania Convention Center, Philadelphia, PA, USA, August 24‐28, 2019 Pharmacoepidemiol Drug Saf 2019;28 (Suppl 2):374-5. Abstract 772. Full text (link to original source) Full text (in our servers)
  9. Saito J, Yakuwa N, Kaneko K, Takai C, Goto M, Nakajima K, Yamatani A, Murashima A. Tocilizumab during pregnancy and lactation: drug levels in maternal serum, cord blood, breast milk and infant serum. Rheumatology (Oxford). 2019 Aug 1;58(8):1505-1507. Abstract
  10. 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)
  11. 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)
  12. Saito J, Yakuwa N, Takai C, Nakajima K, Kaneko K, Goto M, Ishikawa Y, Murashima A. Tocilizumab concentrations in maternal serum and breast milk during breastfeeding and a safety assessment in infants: a case study. Rheumatology (Oxford). 2018 Aug 1;57(8):1499-1501. Abstract
  13. 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
  14. Anderson PO. Drug Treatment of Rheumatoid Arthritis During Breastfeeding. Breastfeed Med. 2018 Nov;13(9):575-577. Abstract
  15. González-Medina M, Curto-Barredo L, Labrador-Horrillo M, Giménez-Arnau A. Omalizumab use during pregnancy for chronic spontaneous urticaria (CSU): report of two cases. J Eur Acad Dermatol Venereol. 2017 May;31(5):e245-e246. Abstract
  16. 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
  17. Ensina LF, Cusato-Ensina AP, Camelo-Nunes IC, Solé D. Omalizumab as Third-Line Therapy for Urticaria During Pregnancy. J Investig Allergol Clin Immunol. 2017;27(5):326-327. Abstract
  18. Anderson PO. Monoclonal Antibodies. Breastfeed Med. 2016 Apr;11:100-1. Abstract
  19. 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)
  20. 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)
  21. EMA. Omalizumab. Drug Summary. 2016 Full text (in our servers)
  22. EMA. Omalizumab. Ficha técnica. 2016 Full text (in our servers)
  23. Comité de Medicamentos de la Asociación Española de Pediatría. Omalizumab. Pediamécum. 2015 Full text (in our servers)
  24. 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)
  25. 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
  26. 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)
  27. 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
  28. FDA. Omalizumab. Drug Summary. 2007 Full text (in our servers)

Total visits


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

e-lactancia is a resource recommended by Asociación Española de Bancos de Leche Humana of Spain

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