Last update July 17, 2022

Tocilizumab

Compatible

Safe product and/or breastfeeding is the best option.

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. Used experimentally in the treatment of the COVID-19 coronavirus. (Alzghari 2020, SEFH 2020)

Its very high molecular weight explains the minute transfer to breastmilk which has been observed (Saito 2021, 2019 & 2018, Moriyama 2020). 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 (Witzel 2014), except in premature infants and the immediate neonatal period, when there may be greater intestinal absorption.

Plasma levels in a breastfed infant were undetectable or very low, even in the neonatal period (Saito 2019).

No clinical, developmental or immunization (vaccines) problems have been observed in infants whose mothers were taking it during the first 9 to 12 months of life. (Saito 2021, 2019 y 2018, Salonga 2018, Nakajima 2016)

Several medical associations, experts and expert consensus consider the use of this medication to be compatible or probably compatible during breastfeeding (Jorgensen 2022, Sammaritano 2020, Briggs 2017, Götestam 2016) if there are no other safer options available.


See below the information of this related product:

Alternatives

  • Adalimumab (Safe product and/or breastfeeding is the best option.)
  • Certolizumab (Safe product and/or breastfeeding is the best option.)
  • Etanercept (Safe product and/or breastfeeding is the best option.)
  • Infliximab (Safe product and/or breastfeeding is the best option.)

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

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Other names

Tocilizumab is also known as


Tocilizumab in other languages or writings:

Groups

Tocilizumab belongs to these groups or families:

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
T½ 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. Anderson PO. COVID-19 Drugs and Breastfeeding Update. Breastfeed Med. 2022 Apr 6. Consulted on May 5, 2022 Abstract
  2. 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)
  3. Jorgensen SCJ, Lapinsky SE. Tocilizumab for coronavirus disease 2019 in pregnancy and lactation: a narrative review. Clin Microbiol Infect. 2022 Jan;28(1):51-57. Abstract Full text (link to original source)
  4. Saito J, Yakuwa N, Kaneko K, Goto M, Kawasaki H, Hamamachi Y, Suzuki T, Sago H, Yamatani A, Murashima A. Tocilizumab drug levels during pregnancy and lactation: A woman who discontinued tocilizumab therapy until the end of the first trimester and resumed it after birth. Obstet Med. 2021 Dec;14(4):260-262. Abstract
  5. 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)
  6. Moriyama M, Wada Y, Minamoto T, Kondo M, Honda M, Murakawa Y. Unexpectedly lower proportion of placental transferred tocilizumab relative to whole immunoglobulin G: a case report. Scand J Rheumatol. 2020 Mar;49(2):165-166. Abstract
  7. Alzghari SK, Acuña VS. Supportive Treatment with Tocilizumab for COVID-19: A Systematic Review. J Clin Virol. 2020 Jun;127:104380. Abstract
  8. 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. None 2020 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. EMA. Tocilizumab. Ficha técnica. 2018 Full text (in our servers)
  11. EMA. Tocilizumab. Drug Summary. 2018 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. 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)
  14. 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 Sep;26(5):667-71. Abstract Full text (link to original source) Full text (in our servers)
  15. 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)
  16. 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
  17. 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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