Last update Feb. 25, 2021

L04AC14

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

A human monoclonal antibody (IgG1 subtype) selective against the interleukin-6 receptor.
Used alone or associated with methotrexate in moderate to severe rheumatoid arthritis.
Administration via subcutaneous injection every 2 weeks over several months.

We did not find published data regarding the excretion of this substance through breast milk at the time this last update was completed.

It´s very high molecular weight (> 100,000 Da) makes it very unlikely to pass into breast milk in a significant quantity, since molecules of more than 800 - 1,000 Da do not pass into breast milk (Hale, Almas 2016, Anderson 2016).

Null or negligible passage into breast milk of similar monoclonal antibodies, such as adalimumab, belimumab, certolizumab, golimumab, infliximab, ipilimumab, natalizumab, rituximab, tocilizumab and ustekinumab has been confirmed (Bar-Gil 2021, LaHue 2020, Ciplea 2020, Saito 2020, 2019 and 2018, Krysko 2019, Whittam 2019, Klenske 2019, Matro 2018, Anderson 2018, Bragnes 2017, Witzel 2014, Ross 2014, Fritzsche 2012).

Due to its protein nature, it is inactivated in the gastrointestinal tract without being absorbed (practically nil oral bioavailability) and this hinders or prevents its passage into the infant´s plasma from ingested breast milk (Lactmed, Rademaker 2018, Bragnes 2017, Götestam 2016 , Witzel 2014, Butler 2014, Mervic 2014) except for premature infants and during the immediate neonatal period when there might be a greater intestinal permeability (Sammaritano 2020).

No problems have been detected in infants whose mothers received other similar monoclonal antibodies such as belimumab, bevacizumab, infliximab, rituximab, tocilizumab, or ustekinumab (Bar-Gil 2021, LaHue 2020, Saito 2020, 2019 and 2018, Klenske 2019, Mugheddu 2019, Krysko 2019, Matro 2018, Bragnes 2017, Hyrich 2014, Danve 2014).

Given its pharmacological properties, breastfeeding should not be discouraged when sarilumab is used if there are no other options available (Götestam-EULAR 2016).
Expert authors consider that the use of monoclonal antibodies during breastfeeding is safe or very likely to be safe (Whittam 2019, Matro 2018, Anderson 2018 and 2016, Witzel 2014, Pistilli 2013).

Given the strong evidence that exists on the benefits of breastfeeding and the development of babies and the health of their mothers, it might be appropriate to evaluate the risk-benefit of any maternal treatment, and counsel individually each mother who wishes to continue breastfeeding (Koren 2013).


See below the information of this related product:

Alternatives

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

L04AC14 is Sarilumab in ATC Code/s.

Is written in other languages:

Groups

L04AC14 belongs to these groups or families:

Tradenames

Main tradenames from several countries containing L04AC14 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 0 %
Molecular weight 144.130 daltons
VD 0.12 l/Kg
Tmax 24 - 48 hours
T½ 240 - 504 hours

References

  1. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on April 16, 2024 Full text (link to original source)
  2. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  3. Pluma A, Hamroun S, Rüegg L, Cecchi I, Kramer M, Perez-Garcia LF, Rivero T, Finckh A, Meissner Y, Förger F. Antirheumatic drugs in reproduction, pregnancy, and lactation: a systematic literature review informing the 2024 update of the EULAR recommendations. Ann Rheum Dis. 2025 Sep;84(9):1561-1590. Abstract Full text (link to original source)
  4. Rüegg L, Pluma A, Hamroun S, Cecchi I, Perez-Garcia LF, Anderson PO, Andreoli L, Wirström SB, Boyadhzieva V, Chambers C, Costedoat-Chalumeau N, Dolhain RJEM, Fischer-Betz R, Giles I, Gøtestam-Skorpen C, Hoeltzenbein M, Marchiori F, Mayer-Pickel K, Molto A, Nelson-Piercy C, Nielsen OH, Tincani A, et al. EULAR recommendations for use of antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. Ann Rheum Dis. 2025 Jun;84(6):910-926. Abstract Full text (link to original source)
  5. Mizutani S, Okunishi Y, Tamada T, Tanaka H, Ito Y, Yamamoto Y, Kitamura A, Tanaka H, Ikeda T, Nakajima A. A Woman with Rheumatoid Arthritis Who Successfully Delivered a Healthy Child with Continuous Administration of Sarilumab Throughout Pregnancy. Intern Med. 2023 Feb 15;62(4):633-636. Abstract Full text (link to original source)
  6. 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)
  7. 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)
  8. 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)
  9. 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)
  10. Anderson PO. Drug Treatment of Rheumatoid Arthritis During Breastfeeding. Breastfeed Med. 2018 Nov;13(9):575-577. Abstract
  11. EMA-Sanofi Aventis. Sarilumab (Kevzara). Ficha técnica. 2017 Full text (in our servers)
  12. EMA-Sanofi Aventis. Sarilumab (Kevzara). Drug Summary. 2017 Full text (in our servers)
  13. Anderson PO. Monoclonal Antibodies. Breastfeed Med. 2016 Apr;11:100-1. Abstract
  14. 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)
  15. 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)
  16. 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
  17. 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)

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