Last update March 5, 2021

Certolizumab

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

It is a humanised monoclonal antibody directed against TNFα (tumour necrosis factor alpha) that is used for treatment of autoimmune diseases like Rheumatoid Arthritis, Axial spondyloarthritis, Ankylosing spondylitis, Psoriatic arthritis and Crohn's Disease unresponsive to conventional treatment.
Injected subcutaneous administration every 2 weeks for months.

Probably because of a high molecular weight, no detectable traces or very low concentrations have been found in mother's milk (Morita 2018, Matro 2018, EMA 2018, Clowse 2017, Forger 2016, Mahadevan 2013).

It is not absorbed by the gut which is even more protective for the nursing infant.

No harm effect has been shown among breastfed infants whose mothers were treated with this medication (Clowse 2017, Mahadevan 2013 & 2012).

The manufacturer (EMA 2018) and expert authors and medical associations consider it compatible with breastfeeding (Hale, Owczarek 2020, Sammaritano 2020, Picardo 2019, Mahadevan 2019 y 2017, Amin 2018, Matro 2018, Clowse 2017, Flint 2016, Gotestam-EULAR 2016, Briggs 2015, Damas 2015, Chaparro 2015, Nielsen 2014, Gisbert 2013 y 2011, Yarur 2013, Mahadevan 2011, van der Woude 2010, Fischer 2010).

It may be prudent to avoid its use in the two post-partum weeks since significant excretion into the milk within the first 3 - 4 days after delivery and absorption by the infant is possible.


See below the information of these related products:

Alternatives

We do not have alternatives for Certolizumab since it is relatively safe.

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

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.

Other names

Certolizumab is also known as


Certolizumab in other languages or writings:

Groups

Certolizumab belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Certolizumab in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≈ 0 %
Molecular weight 91.000 daltons
VD 0.11 l/Kg
Tmax 54 - 171 hours
336 hours
Theoretical Dose 0 - 0.01 mg/Kg/d
Relative Dose 0 - 0.15 %

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on March 17, 2022 Full text (link to original source)
  2. 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 March 15, 2022 Full text (link to original source)
  3. Owczarek W, Walecka I, Lesiak A, Czajkowski R, Reich A, Zerda I, Narbutt J. The use of biological drugs in psoriasis patients prior to pregnancy, during pregnancy and lactation: a review of current clinical guidelines. Postepy Dermatol Alergol. 2020 Dec;37(6):821-830. Abstract Full text (link to original source)
  4. 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)
  5. Picardo S, Seow CH. A Pharmacological Approach to Managing Inflammatory Bowel Disease During Conception, Pregnancy and Breastfeeding: Biologic and Oral Small Molecule Therapy. Drugs. 2019 Jul;79(10):1053-1063. Abstract
  6. Mahadevan U, Robinson C, Bernasko N, Boland B, Chambers C, Dubinsky M, Friedman S, Kane S, Manthey J, Sauberan J, Stone J, Jain R. Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway: A Report From the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. 2019 Apr;156(5):1508-1524. Abstract
  7. Lamb CA, Kennedy NA, Raine T, Hendy PA, Smith PJ, Limdi JK, Hayee B, Lomer MCE, Parkes GC, Selinger C, Barrett KJ, Davies RJ, Bennett C, Gittens S, Dunlop MG, Faiz O, Fraser A, Garrick V, Johnston PD, Parkes M, Sanderson J, Terry H; et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut. 2019 Dec;68(Suppl 3):s1-s106. Abstract Full text (link to original source)
  8. EMA. Certolizumab Drug Summary 2018 Full text (link to original source) Full text (in our servers)
  9. Morita T, Fujimoto K, Shima Y, Ogata A, Kumanogoh A. Minimal neonatal transfer of certolizumab pegol in a Japanese patient with rheumatoid arthritis. Ann Rheum Dis. 2018 Sep;77(9):e56. Abstract
  10. 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)
  11. Amin M, No DJ, Egeberg A, Wu JJ. Choosing First-Line Biologic Treatment for Moderate-to-Severe Psoriasis: What Does the Evidence Say? Am J Clin Dermatol. 2018 Feb;19(1):1-13. Abstract
  12. EMA. Certolizumab. Ficha técnica. 2018 Full text (link to original source) Full text (in our servers)
  13. Mahadevan U, McConnell RA, Chambers CD. Drug Safety and Risk of Adverse Outcomes for Pregnant Patients With Inflammatory Bowel Disease. Gastroenterology. 2017 Feb;152(2):451-462.e2. Abstract
  14. Clowse ME, Förger F, Hwang C, Thorp J, Dolhain RJ, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Toublanc N, Wang M, Hale TW. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017 Nov;76(11):1890-1896. Abstract Full text (link to original source) Full text (in our servers)
  15. Förger F, Zbinden A, Villiger PM. Certolizumab treatment during late pregnancy in patients with rheumatic diseases: Low drug levels in cord blood but possible risk for maternal infections. A case series of 13 patients. Joint Bone Spine. 2016 May;83(3):341-3. Abstract
  16. 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)
  17. Flint J, Panchal S, Hurrell A, van de Venne M, Gayed M, Schreiber K, Arthanari S, Cunningham J, Flanders L, Moore L, Crossley A, Purushotham N, Desai A, Piper M, Nisar M, Khamashta M, Williams D, Gordon C, Giles I; BSR and BHPR Standards, Guidelines and Audit Working Group. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016 Sep;55(9):1693-7. Abstract Full text (link to original source) Full text (in our servers)
  18. 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
  19. Chaparro M. [Natural history, complications, safety and pregnancy in inflammatory bowel disease]. Gastroenterol Hepatol. 2015 Sep;38 Suppl 1:20-31. Abstract
  20. Damas OM, Deshpande AR, Avalos DJ, Abreu MT. Treating Inflammatory Bowel Disease in Pregnancy: The Issues We Face Today. J Crohns Colitis. 2015 Oct;9(10):928-36. Abstract Full text (in our servers)
  21. 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)
  22. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014 Feb;11(2):116-27. Abstract
  23. Mahadevan U, Wolf DC, Dubinsky M, Cortot A, Lee SD, Siegel CA, Ullman T, Glover S, Valentine JF, Rubin DT, Miller J, Abreu MT. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013 Mar;11(3):286-92; quiz e24. Abstract Full text (link to original source) Full text (in our servers)
  24. Yarur A, Kane SV. Update on pregnancy and breastfeeding in the era of biologics. Dig Liver Dis. 2013 Oct;45(10):787-94. Abstract Full text (link to original source) Full text (in our servers)
  25. Gisbert JP, Chaparro M. Safety of anti-TNF agents during pregnancy and breastfeeding in women with inflammatory bowel disease. Am J Gastroenterol. 2013 Sep;108(9):1426-38. Abstract
  26. Mahadevan U, Martin CF, Sandler RS, et al. PIANO: A 1000 patient prospective registry of pregnancy outcomes in women with IBD exposed to immunomodulators and biologic therapy. Presented at Digestive Disease Week; May 19-22, 2012; San Diego, California. Gastroenterology. 2012;142 (Suppl 1):S149. Abstract 865. 2012 Full text (link to original source) Full text (in our servers)
  27. Mahadevan U, Cucchiara S, Hyams JS, Steinwurz F, Nuti F, Travis SP, Sandborn WJ, Colombel JF. The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn's and Colitis Organisation: pregnancy and pediatrics. Am J Gastroenterol. 2011 Feb;106(2):214-23; quiz 224. Abstract
  28. van der Woude CJ, Kolacek S, Dotan I, Oresland T, Vermeire S, Munkholm P, Mahadevan U, Mackillop L, Dignass A; European Crohn's Colitis Organisation (ECCO). European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohns Colitis. 2010 Abstract Full text (link to original source) Full text (in our servers)
  29. Gisbert JP. Safety of immunomodulators and biologics for the treatment of inflammatory bowel disease during pregnancy and breast-feeding. Inflamm Bowel Dis. 2010 May;16(5):881-95. Abstract
  30. Fischer-Betz RE, Schneider M. [Biologics during pregnancy and breast--feeding]. Z Rheumatol. 2010 Abstract

Total visits

7,844

Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write us at elactancia.org@gmail.com

e-lactancia is a resource recommended by Asociación Española de Bancos de Leche Humana of Spain

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM