Is Tocilizumab compatible with breastfeeding? Do we have alternatives for Tocilizumab?

Tocilizumab

August 30, 2018 (Very Low Risk)

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

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Synonyms

  • Atlizumab
  • Immunoglobulin G1, anti-(human interleukin 6 receptor)

Writings

  • توسيليزوماب (Arabic)
  • Тоцилизумаб (Cyrillic)
  • 托珠单抗 (Chinese)
  • トシリズマブ (Japanese)
  • C6428 H9976 N1720 O2018 S42 (Molecular formula)
  • Immunoglobulin G1, anti-(human interleukin 6 receptor) (human-mouse monoclonal MRA heavy chain), disulfide with human-mouse monoclonal MRA κ-chain, dimer (Chemical name)
  • L04AC07 (ATC Code/s)

Drug trade names

References

  1. 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)
  2. EMA. Tocilizumab. Drug Summary. 2018 Full text (in our servers)
  3. EMA. Tocilizumab. Ficha técnica. 2018 Full text (in our servers)
  4. 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). 2018Abstract
  5. 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
  6. 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. 2016Abstract Full text (link to original source) Full text (in our servers)
  7. 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. 2016Abstract Full text (link to original source) Full text (in our servers)