Last update April 9, 2023


Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Monoclonal antibody, immunoglobulin G anti CD20 composed of 664 amino acids. Indicated in the treatment of rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener) and associated with methotrexate in severe active rheumatoid arthritis. Intravenous administration every week, two weeks or two months depending on the disease being treated.

It is excreted in breast milk in very small amounts (Bosshard 2021, Krysko 2019, Bragnes 2017) in line with its very high molecular weight, as is the case with other IgG1 monoclonal antibodies such as infliximab and adalimumab. (Bragnes 2017, Fritzsche 2012)

The plasma levels of infants whose mothers take them are no detectable. (Bosshard 2021)

An infant whose mother received a dose of 1 g of Rituximab at 3 months had no side effects at 1.5 years of follow-up (Bragnes 2017). Five other infants had no problems after 8 to 12 months of follow-up (Hersey 2020, Krysko 2019). The blood counts and immunoglobulins of 6 other infants were normal. (Rød 2022)

Due to its protein nature it is inactivated in the gastrointestinal tract, not being absorbed, (oral bioavailability practically null), which hinders or prevents the passage to infant plasma from the ingested breast milk (Bragnes 2017, Götestam 2016, Butler 2014, Pistilli 2013), except in premature babies and the immediate neonatal period, when there may be greater intestinal permeability.

Based on its pharmacological properties, breastfeeding should not be discouraged when using rituximab if no other options are available (Dobson 2023, Bosshard 2021, Krysko 2019, Whittam 2019, Götestam-EULAR 2016). Although previously not recommended during lactation (Makol 2011), especially during the neonatal period and in case of prematurity (Almas 2016, Ostensen 2009), more recently, various experts (Dobson 2023, Bosshard 2021, Sammaritano 2020, Ciplea 2020, Krysko 2019, Bragnes 2017, Noviani 2016, Pistilli 2013) consider safe or probably safe the use of this medication during lactation.

Given the strong evidence that exists on the benefits of breastfeeding for the development of babies and the health of mothers, it is advisable to evaluate the risk-benefit of any maternal treatment, including chemotherapy, individually advising each mother that wishes to continue with breastfeeding. (Koren 2013)

See below the information of these related products:

  • Maternal Cancer ( Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.)
  • Maternal Rheumatoid arthritis (RA) (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)


  • Hydroxychloroquine Sulfate ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Infliximab ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Sulfasalazine ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

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

Rituximab in other languages or writings:


Variable Value Unit
Oral Bioavail. 0 %
Molecular weight 143.860 daltons
VD 3.1 - 4.5 l/Kg
528 (146 - 1.248) hours
Theoretical Dose 0.000075 - 0.01455 mg/Kg/d
Relative Dose 0.0005 - 0.09 %


  1. Dobson R, Rog D, Ovadia C, Murray K, Hughes S, Ford HL, Pearson OR, White S, Bonham N, Mathews J, Nelson-Piercy C, Brex P. Anti-CD20 therapies in pregnancy and breast feeding: a review and ABN guidelines. Pract Neurol. 2023 Feb;23(1):6-14. Consulted on April 9, 2023 Abstract Full text (link to original source)
  2. Rød B, Bø L, Myhr K, Torkildsen Ø, Wergeland S. Rituximab exposure from breastfeeding. A case series. Multiple Sclerosis Journal. 2022;28(1) Suppl:210–11. Poster 414. Consulted on July 16, 2022 Full text (link to original source) Full text (in our servers)
  3. 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
  4. 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)
  5. Russell MD, Dey M, Flint J, Davie P, Allen A, Crossley A, Frishman M, Gayed M, Hodson K, Khamashta M, Moore L, Panchal S, Piper M, Reid C, Saxby K, Schreiber K, Senvar N, Tosounidou S, van de Venne M, Warburton L, Williams D, Yee CS, et al. British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2022 Nov 2. pii: keac551. Abstract Full text (link to original source)
  6. Bosshard N, Zbinden A, Eriksson KK, Förger F. Rituximab and Canakinumab Use During Lactation: No Detectable Serum Levels in Breastfed Infants. Rheumatol Ther. 2021 Jun;8(2):1043-1048. Abstract Full text (link to original source)
  7. 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)
  8. 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)
  9. 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)
  10. Hersey AE, Giglio P, Kurt H, Tarabulsi G, Chen KK. Diffuse Large B-Cell Lymphoma During Third-Trimester Pregnancy and Lactation. Obstet Gynecol. 2020 Feb;135(2):383-386. Abstract
  11. Langer-Gould AM. Pregnancy and Family Planning in Multiple Sclerosis. Continuum (Minneap Minn). 2019 Jun;25(3):773-792. Abstract
  12. 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)
  13. 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)
  14. EMA. Rituximab. Ficha técnica. 2018 Full text (in our servers)
  15. EMA. Rituximab. Drug Summary. 2018 Full text (in our servers)
  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. 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)
  18. Noviani M, Wasserman S, Clowse ME. Breastfeeding in mothers with systemic lupus erythematosus. Lupus. 2016 Aug;25(9):973-9. 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. Calligaro A, Hoxha A, Ruffatti A, Punzi L. Are biological drugs safe in pregnancy? Reumatismo. 2015 Abstract Full text (link to original source)
  21. 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
  22. 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)
  23. 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
  24. Koren G, Carey N, Gagnon R, Maxwell C, Nulman I, Senikas V; Society of Obstetricians and Gynaecologists of Canada. Cancer chemotherapy and pregnancy. J Obstet Gynaecol Can. 2013 Mar;35(3):263-278. Abstract Full text (link to original source) Full text (in our servers)
  25. Fritzsche J, Pilch A, Mury D, Schaefer C, Weber-Schoendorfer C. Infliximab and adalimumab use during breastfeeding. J Clin Gastroenterol. 2012 Sep;46(8):718-9. Abstract
  26. Makol A, Wright K, Amin S. Rheumatoid arthritis and pregnancy: safety considerations in pharmacological management. Drugs. 2011 Abstract
  27. Ostensen M. Management of early aggressive rheumatoid arthritis during pregnancy and lactation. Expert Opin Pharmacother. 2009 Abstract
  28. Friedrichs B, Tiemann M, Salwender H, Verpoort K, Wenger MK, Schmitz N. The effects of rituximab treatment during pregnancy on a neonate. Haematologica. 2006 Abstract Full text (link to original source) Full text (in our servers)

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