Last update June 9, 2026

Certolizumab, Certolizumab Pegol

Compatible

Safe product and/or breastfeeding is the best option.

Humanised monoclonal antibody against tumour necrosis factor alpha (TNFα) used in autoimmune diseases such as rheumatoid arthritis, axial spondyloarthritis, ankylosing spondylitis, psoriatic arthritis and Crohn’s disease where there has been a poor response to conventional therapy. Administered by subcutaneous injection every 2 weeks for several months. 

No detectable or very low levels have been found in breast milk (Morita 2018, Matro 2018, EMA 2018, Clowse 2017, Förger 2016, Mahadevan 2013), probably due to its extremely high molecular weight. The polyethylene glycol in its pegylated form is also not excreted in breast milk. (Clowse 2017)

Due to its protein nature, it is inactivated in the gastrointestinal tract and is not absorbed (oral bioavailability is practically zero), which hinders or prevents its passage into the infant’s plasma from ingested breast milk. (Anderson 2018)

No short- or long-term developmental, infectious or immunological problems, nor any issues with vaccination, have been observed in infants of mothers taking the drug (Sahuquillo 2024, Membrive 2023, Lambiase 2022, Pieto 2021, Matro 2018, Clowse 2017, Mahadevan 2013 and 2012) and no levels, or very low levels, were detected in the plasma of these infants. (Mahadevan 2013)

Anti-TNF drugs reduce levels of tumour necrosis factor (TNF) in breast milk (Sepiashvili 2025). Milk production should be monitored, as this reduction in TNF, which plays a role in milk production, could increase the risk of lactation failure. (Yan 2026)

The manufacturer (EMA 2018) and expert authors and medical associations consider it compatible with breastfeeding. (Hale, Rüegg 2025, Mahadevan 2025, Hoxha 2025, Torres 2023, Russell 2023, Thatiparthi 2021, Owczarek 2020, Sammaritano 2020, Smith 2020, Yeung 2020, Lamb 2019, Picardo 2019, Mahadevan 2019 and 2017, Amin 2018, Matro 2018, Clowse 2017, Flint 2016, Götestam-EULAR 2016, Briggs 2015, Damas 2015, Chaparro 2015, Nielsen 2014, Witzel 2014, Gisbert 2013 and 2011, Yarur 2013, Mahadevan 2011, van der Woude 2010, Fischer 2010)


See below the information of these related products:

Alternatives

  • Adalimumab (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.)
  • Tocilizumab (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

Certolizumab, Certolizumab Pegol in other languages or writings:

Groups

Certolizumab, Certolizumab Pegol belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Certolizumab, Certolizumab Pegol in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≈ 0 %
Molecular weight 91.000 daltons
VD 0.11 l/Kg
Tmax 54 - 171 hours
T½ 336 hours
M/P ratio 0.0016 -
Theoretical Dose 0 - 0.04 mg/Kg/d
Relative Dose 0 - 0.3 %

References

  1. 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)
  2. Yan Z, Chen H, Sun J, Chen T, Zhang W, He Y, He J, Zhang C. Divergent safety profiles of TNF inhibitors in pregnancy: a comprehensive pharmacovigilance analysis of the FAERS database. J Autoimmun. 2026 May;160:103553. Abstract
  3. 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)
  4. Mahadevan U, Seow CH, Barnes EL, Chaparro M, Flanagan E, Friedman S, Julsgaard M, Kane S, Ng S, Torres J, Watermeyer G, Yamamoto-Furusho J, Robinson C, Fisher S, Anderson P, Gearry R, Duricova D, Dubinsky M, Long M; Global Consensus Group for Pregnancy and IBD. Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2025 Oct;23(11S):S1-S60. Abstract
  5. Hoxha T, Youssef M, Huang V, Tandon P. Inflammatory Bowel Disease and Breastfeeding: A Narrative Review. Inflamm Bowel Dis. 2025 Jan 6;31(1):210-219. Abstract
  6. Sahuquillo-Torralba A, Mansilla-Polo M, Pujol-Marco C, Llamas-Velasco M, Rull EV, Ruiz Villaverde R, Ferran M, Pitarch G, Lopez A, Beltran E, Urruticoechea-Arana A, Riera-Monroig J, Alsina M, Vidal D, Belinchón Romero I, Notario J, Carrascosa JM, Gonzalez-Delgado V, Mollet J, Ribera M, Gallardo F. Certolizumab pegol effectiveness, survival and safety in patients with psoriasis: A multicenter retrospective analysis in daily clinical practice by the Spanish Psoriasis Group. Int J Dermatol. 2024 Dec;63(12):1720-1727. Abstract
  7. Russell MD, Dey M, Flint J, Davie P, Allen A, Crossley A, Frishman M, Gayed M, Hodson K, Khamashta M, Moore L, Panchal S, Piper M, Reid C, Saxby K, Schreiber K, Senvar N, Tosounidou S, van de Venne M, Warburton L, Williams D, Yee CS, et al. British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2023 Apr 3;62(4):e48-e88. Abstract Full text (link to original source)
  8. Torres J, Chaparro M, Julsgaard M, Katsanos K, Zelinkova Z, Agrawal M, Ardizzone S, Campmans-Kuijpers M, Dragoni G, Ferrante M, Fiorino G, Flanagan E, Gomes CF, Hart A, Hedin CR, Juillerat P, Mulders A, Myrelid P, O'Toole A, Rivière P, Scharl M, Selinger CP, et al. European Crohn's and Colitis Guidelines on Sexuality, Fertility, Pregnancy, and Lactation. J Crohns Colitis. 2023 Jan 27;17(1):1-27. Abstract Full text (link to original source)
  9. 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)
  10. Membrive-Jiménez C, Sánchez-Piedra C, Martínez-González O, García-González J, Expósito-Pérez L, Bohórquez-Heras C, Campos-Fernández C, Sanchez-Alonso F, Cáliz-Cáliz R, Castrejón-Fernández I. Safety and effectiveness of bDMARDs during pregnancy in patients with rheumatic diseases: Real-world data from the BIOBADASER registry. Reumatol Clin (Engl Ed). 2023 Nov;19(9):500-506. Abstract Full text (link to original source)
  11. Lambiase S, Pensa C, Shumak RG, Bianchi L, Dattola A. Certolizumab pegol in pregnant and breastfeeding psoriatic patients. Ital J Dermatol Venerol. 2022 Aug;157(4):383-384. Abstract
  12. Anderson PO. Monoclonal Antibodies During Breastfeeding. Breastfeed Med. 2021 Aug;16(8):591-593. Abstract
  13. Prieto-Peña D, Calderón-Goercke M, Adán A, Chamorro-López L, Maíz-Alonso O, De Dios-Jiménez Aberásturi JR, Veroz R, Blanco S, Martín-Santos JM, Navarro F, Gallego A, González-Suárez S, Conesa A, García-Valle A, Cordero-Coma M, Pardiñas-Barón N, Demetrio R, Calvo-Río V, Martínez-Taboada VM, Castañeda S, Hernández JL, González-Gay MA, et al. Efficacy and safety of certolizumab pegol in pregnant women with uveitis. Recommendations on the management with immunosuppressive and biologic therapies in uveitis during pregnancy. Clin Exp Rheumatol. 2021 Jan-Feb;39(1):105-114. Abstract
  14. Thatiparthi A, Martin A, Liu J, Egeberg A, Wu JJ. Biologic Treatment Algorithms for Moderate-to-Severe Psoriasis with Comorbid Conditions and Special Populations: A Review. Am J Clin Dermatol. 2021 Jul;22(4):425-442. Abstract Full text (link to original source)
  15. 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)
  16. Smith CH, Yiu ZZN, Bale T, Burden AD, Coates LC, Edwards W, MacMahon E, Mahil SK, McGuire A, Murphy R, Nelson-Piercy C, Owen CM, Parslew R, Uthman OA, Woolf RT, Manounah L, Ezejimofor MC, Exton LS, Mohd Mustapa MF; British Association of Dermatologists’ Clinical Standards Unit. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update. Br J Dermatol. 2020 Oct;183(4):628-637. Abstract
  17. Yeung J, Gooderham MJ, Grewal P, Hong CH, Lansang P, Papp KA, Poulin Y, Turchin I, Vender R. Management of Plaque Psoriasis With Biologic Therapies in Women of Child-Bearing Potential Consensus Paper. J Cutan Med Surg. 2020 Jul/Aug;24(1_suppl):3S-14S. Abstract
  18. 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)
  19. 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)
  20. 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 Full text (link to original source)
  21. 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
  22. EMA. Certolizumab Drug Summary 2018 Full text (link to original source) Full text (in our servers)
  23. EMA. Certolizumab. Ficha técnica. 2018 Full text (link to original source) Full text (in our servers)
  24. 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
  25. 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
  26. 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)
  27. 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)
  28. 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
  29. 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)
  30. 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)
  31. 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
  32. Chaparro M. [Natural history, complications, safety and pregnancy in inflammatory bowel disease]. Gastroenterol Hepatol. 2015 Sep;38 Suppl 1:20-31. Abstract
  33. 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
  34. 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 (link to original source) Full text (in our servers)
  35. 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)
  36. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014 Feb;11(2):116-27. Abstract
  37. 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
  38. 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)
  39. 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)
  40. 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)
  41. 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
  42. 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)
  43. 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
  44. Fischer-Betz RE, Schneider M. [Biologics during pregnancy and breast--feeding]. Z Rheumatol. 2010 Abstract

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