Last update: Nov. 19, 2019

Rituximab

Very Low Risk for breastfeeding


Safe. Compatible.
Not risky for breastfeeding or 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 (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). 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). Four other infants had no problems after 8 to 12 months of follow-up (Krysko 2019).

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 (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 (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).

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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.

Group

Rituximab belongs to this group or family:

Tradenames

Main tradenames from several countries containing Rituximab in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 0 %
Molecular weight 143.860 daltons
VD 3,1 - 4.5 l/Kg
T1/2 528 (146 - 1.248) hours
Theoretical Dose 0,000075 - 0,01455 mg/Kg/d
Relative Dose 0,0005 - 0,09 %

References

  1. 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)
  2. 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)
  3. Langer-Gould AM. Pregnancy and Family Planning in Multiple Sclerosis. Continuum (Minneap Minn). 2019 Jun;25(3):773-792. Abstract
  4. 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)
  5. EMA. Rituximab. Drug Summary. 2018 Full text (in our servers)
  6. EMA. Rituximab. Ficha técnica. 2018 Full text (in our servers)
  7. 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
  8. Almas S, Vance J, Baker T, Hale T. Management of Multiple Sclerosis in the Breastfeeding Mother. Mult Scler Int. 2016 Abstract Full text (link to original source) Full text (in our servers)
  9. 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)
  10. Noviani M, Wasserman S, Clowse ME. Breastfeeding in mothers with systemic lupus erythematosus. Lupus. 2016 Aug;25(9):973-9. Abstract
  11. Calligaro A, Hoxha A, Ruffatti A, Punzi L. Are biological drugs safe in pregnancy? Reumatismo. 2015 Abstract Full text (link to original source) Full text (in our servers)
  12. 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
  13. 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)
  14. 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)
  15. 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
  16. 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
  17. Makol A, Wright K, Amin S. Rheumatoid arthritis and pregnancy: safety considerations in pharmacological management. Drugs. 2011 Abstract
  18. Ostensen M. Management of early aggressive rheumatoid arthritis during pregnancy and lactation. Expert Opin Pharmacother. 2009 Abstract
  19. 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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