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

Certolizumab

June 10, 2018 (Very Low Risk)

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 have been found in mother's milk (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 (Mahadevan 2017, Clowse 2017, Flint 2016, Gotestam 2016, Damas 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.

Alternatives

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

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

  • CDP-870
  • Certolizumab Pegol
  • PHA-738144

Writings

  • Κερτολιζουμάμπη (Greek)
  • سارتوليزوماب بيغول (Arabic)
  • Цертолизумаб Пегол (Cyrillic)
  • 培舍珠单抗 (Chinese)
  • セルトリズマブ ペゴル (Japanese)
  • C2115 H3252 N556 O673 S16 (Molecular formula)
  • L04AB05 (ATC Code/s)

Drug trade names

References

  1. 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. 2018Abstract
  2. EMA. Certolizumab. Ficha técnica. 2018 Full text (link to original source) Full text (in our servers)
  3. EMA. Certolizumab Drug Summary 2018 Full text (link to original source) Full text (in our servers)
  4. 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. 2017Abstract Full text (link to original source) Full text (in our servers)
  5. Mahadevan U, McConnell RA, Chambers CD. Drug Safety and Risk of Adverse Outcomes for Pregnant Patients With Inflammatory Bowel Disease. Gastroenterology. 2017Abstract
  6. 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). 2016Abstract Full text (link to original source) Full text (in our servers)
  7. McConnell RA, Mahadevan U. Pregnancy and the Patient with Inflammatory Bowel Disease: Fertility, Treatment, Delivery, and Complications. Gastroenterol Clin North Am. 2016Abstract
  8. 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. 2016Abstract
  9. 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)
  10. Damas OM, Deshpande AR, Avalos DJ, Abreu MT. Treating Inflammatory Bowel Disease in Pregnancy: The Issues We Face Today. J Crohns Colitis. 2015Abstract Full text (in our servers)
  11. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014Abstract
  12. Gisbert JP, Chaparro M. Safety of anti-TNF agents during pregnancy and breastfeeding in women with inflammatory bowel disease. Am J Gastroenterol. 2013Abstract
  13. 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. 2013Abstract Full text (link to original source) Full text (in our servers)
  14. Yarur A, Kane SV. Update on pregnancy and breastfeeding in the era of biologics. Dig Liver Dis. 2013Abstract Full text (link to original source) Full text (in our servers)
  15. 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)
  16. 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. 2011Abstract
  17. 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. 2010Abstract Full text (link to original source) Full text (in our servers)
  18. Gisbert JP. Safety of immunomodulators and biologics for the treatment of inflammatory bowel disease during pregnancy and breast-feeding. Inflamm Bowel Dis. 2010Abstract
  19. Fischer-Betz RE, Schneider M. [Biologics during pregnancy and breast--feeding]. Z Rheumatol. 2010Abstract