Last update: Aug. 30, 2018

Tocilizumab

Very Low Risk for breastfeeding


Safe. Compatible.
Minimal risk for breastfeeding and infant.

A human monoclonal antibody which inhibits the interleukin 6 (IL-6) receptor used in the treatment of rheumatoid arthritis, some forms of juvenile arthritis and in Castleman's disease.
Intravenous administration every 4 weeks.
Its use is authorized in Pediatrics from 2 years of age.

Its very high molecular weight explains the minute transfer to breastmilk which has been observed (Saito 2018). The maximum concentration in milk occurs on the third day and is so low (68 to 148 nanograms/L), that the relative dose that day would be a maximum of 0.007% (Saito 2018).

Its low oral bioavailability suggests that transfer to the infant's plasma from ingested breastmilk is nil or insignificant, except in premature infants and the immediate neonatal period, when there may be greater intestinal absorption.

No clinical, developmental or immunization (vaccines) problems have been observed in infants whose mothers were taking it (Nakajima 2016), during the first 9 to 12 months of life (Saito 2018, Salonga 2018).

Several medical associations, experts and expert consensus consider the use of this medication to be compatible or probably compatible during breastfeeding (Briggs 2017, Götestam 2016) if there are no other safer options available.

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

Tocilizumab belongs to this group or family:

Tradenames

Main tradenames from several countries containing Tocilizumab in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≈ 0 %
Molecular weight 148.000 daltons
VD 0,1 l/Kg
Tmax 48 - 72 hours
T1/2 144 - 300 hours
M/P ratio 0,002 - 0,006 -
Theoretical Dose 0,00001 - 0,00002 mg/Kg/d
Relative Dose 0,0035 - 0,007 %

References

  1. SEFH - Sociedad Española de Farmacia Hospitalaria. Procedimientos de farmacia hospitalaria para la gestión del tratamiento con antivirales en la enfermedad por el nuevo coronavirus sars-cov-2 (COVID-19). Recomendaciones de la Sociedad Española de Farmacia Hospitalaria. 2020 Full text (in our servers)
  2. 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
  3. EMA. Tocilizumab. Drug Summary. 2018 Full text (in our servers)
  4. EMA. Tocilizumab. Ficha técnica. 2018 Full text (in our servers)
  5. Salonga A, Chay J, Nicholls D. A case series of patients with rheumatoid arthritis exposed to tocilizumab during pregnancy. Intern Med J. 2018;48:26-7. Poster 51. 2018 Full text (link to original source) Full text (in our servers)
  6. 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
  7. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. 11th edition (acces on line) 2017
  8. 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)
  9. Nakajima K, Watanabe O, Mochizuki M, Nakasone A, Ishizuka N, Murashima A. Pregnancy outcomes after exposure to tocilizumab: A retrospective analysis of 61 patients in Japan. Mod Rheumatol. 2016 Abstract Full text (link to original source) Full text (in our servers)
  10. 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)

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