The Basics
What is Infliximab?
Used to treat a number of autoimmune diseases.
Brand names for Infliximab
Remicade
How Infliximab is classified
Antibodies – Monoclonal, Antirheumatic Agents, Dermatologic Agents, Gastrointestinal Agents
Infliximab During Pregnancy
Infliximab pregnancy category
Category BNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Infliximab while pregnant
N/A
Taking Infliximab While Breastfeeding
What are recommendations for lactation if you're taking Infliximab?
Infliximab is usually either not detectable in breastmilk or detectable at very low levels. Absorption of the drug from milk by the infant is minimal. Follow-up of infants exposed in utero and breastfed during maternal infliximab therapy have found no adverse effects and normal development. The measurement of minute concentrations in the milk of some women raises the possibility of local immune suppression in the gastrointestinal tact, but levels were not high enough to be of concern for systemic immunosuppression.[1] Although the manufacturer recommends that breastfeeding be discontinued during infliximab therapy, numerous experts have stated that the drug is a low risk to the nursing infant and breastfeeding can continue during infliximab use.[2][3][4][5][6][7][8][9][10][11]
Maternal / infant drug levels
Infliximab is usually either not detectable in breastmilk or detectable at very low levels. Absorption of the drug from milk by the infant is minimal. Follow-up of infants exposed in utero and breastfed during maternal infliximab therapy have found no adverse effects and normal development. The measurement of minute concentrations in the milk of some women raises the possibility of local immune suppression in the gastrointestinal tact, but levels were not high enough to be of concern for systemic immunosuppression.[1] Although the manufacturer recommends that breastfeeding be discontinued during infliximab therapy, numerous experts have stated that the drug is a low risk to the nursing infant and breastfeeding can continue during infliximab use.[2][3][4][5][6][7][8][9][10][11]
Possible effects of Infliximab on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Infliximab
(Inflammatory Bowel Disease) Adalimumab, Certolizumab Pegol; (Psoriasis) Adalimumab, Etanercept, Phototherapy, Tretinoin; (Rheumatoid Arthritis) Adalimumab, Certolizumab Pegol, Etanercept.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Ben-Horin S, Yavzori M, Kopylov U et al. Detection of infliximab in breast milk of nursing mothers with inflammatory bowel disease. J Crohns Colitis. 2011;5:555-8. PMID: 22115374
2. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014;11:116-27. PMID: 23897285
3. Hyrich KL, Verstappen SM. Biologic therapies and pregnancy: The story so far. Rheumatology (Oxford). 2014;53:1377-85. PMID: 24352337
4. Nguyen GC, Seow CH, Maxwell C et al. The Toronto Consensus Statements for the Management of IBD in Pregnancy. Gastroenterology. 2016;150:734-57. PMID: 26688268
5. van der Woude CJ, Ardizzone S, Bengtson MB et al. The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease. J Crohns Colitis. 2015;9:107-24. PMID: 25602023
6. Flint J, Panchal S, Hurrell A et al. 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;55:1693-7. PMID: 26750124
7. Gotestam Skorpen C, Hoeltzenbein M, Tincani A et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75:795-810. PMID: 26888948
8. Amin M, No DJ, Egeberg A et al. Choosing first-line biologic treatment for moderate-to-severe psoriasis: What does the evidence say? Am J Clin Dermatol. 2018;19:1-13. PMID: 29080066
9. Matro R, Martin CF, Wolf D et al. Exposure concentrations of infants breastfed by women receiving biologic therapies for inflammatory bowel diseases and effects of breastfeeding on infections and development. Gastroenterology. 2018;155:696-704. PMID: 29857090
10. Mahadevan U, Robinson C, Bernasko N et al. Inflammatory bowel disease in pregnancy clinical care pathway: A report from the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. 2019;156:1508-24. PMID: 30658060
11. 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;79:1053-63. PMID: 31183768
12. Peltier M, James D et al. Infliximab levels in breast-milk of a nursing Crohn’s patient. Am J Gastroenterol. 2001;96 (9 suppl 1):S312. Abstract.
13. Forger F, Matthias T, Oppermann M et al. Infliximab in breast milk. Lupus. 2004;13:753. Abstract. DOI: doi:10.1191/0961203304lu2014xx
14. Vasiliauskas EA, Church JA, Silverman N et al. Case report: evidence for transplacental transfer of maternally administered infliximab to the newborn. Clin Gastroenterol Hepatol. 2006;4:1255-8. PMID: 17045211
15. Stengel JZ, Arnold HL. Is infliximab safe to use while breastfeeding? World J Gastroenterol. 2008;14:3085-7. PMID: 18494064
16. Kane S, Ford J, Cohen R, Wagner C. Absence of infliximab in infants and breast milk from nursing mothers receiving therapy for Crohn’s disease before and after delivery. J Clin Gastroenterol. 2009;43:613-6. PMID: 19142167
17. Fritzsche J, Pilch A, Mury D et al. Infliximab and adalimumab use during breastfeeding. J Clin Gastroenterol. 2012;46:718-9. PMID: 22858514
18. Grosen A, Julsgaard M, Kelsen J, Christensen LA. Infliximab concentrations in the milk of nursing mothers with inflammatory bowel disease. J Crohn’s Colitis. 2014;8:175-6. PMID: 24090905
19. Steenholdt C, Al-Khalaf M, Ainsworth MA, Brynskov J. Therapeutic infliximab drug level in a child born to a woman with ulcerative colitis treated until gestation week 31. J Crohns Colitis. 2012;6:358-61. PMID: 22405174
20. Vestergaard T, Kammerlander H, Brock B et al. Immunoglobulin and infliximab concentrations in dichorionic twins exposed to infliximab in utero. J Crohns Colitis. 2017;11:1152-3. PMID: 28333258
21. Mahadevan U, Kane S, Sandborn WJ et al. Intentional infliximab use during pregnancy for induction or maintenance of remission in Crohn’s disease. Aliment Pharmacol Ther. 2005;21:733-8. PMID: 15771759
22. Tursi A. Effect of intentional infliximab use throughout pregnancy in inducing and maintaining remission in Crohn’s disease. Dig Liver Dis. 2010;38:439-40. PMID: 16563889
23. Bernard N, Garayt C, Chol F et al. Prospective clinical and biological follow-up of three breastfed babies from azathioprine-treated mothers. Fundam Clin Pharmacol. 2007;21 (Suppl 1):62-3. Abstract. DOI: doi:10.1111/j.1472-8206.2007.00481.x
24. Hou JK, Mahadevan U. A 24-year-old pregnant woman with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2009;7:944-7. PMID: 19410016
25. Puig L, Barco D, Alomar A. Treatment of psoriasis with anti-TNF drugs during pregnancy: case report and review of the literature. Dermatology. 2010;220:71-6. PMID: 19940453
26. Correia LM, Bonilha DQ, Ramos JD et al. Inflammatory bowel disease and pregnancy: report of two cases treated with infliximab and a review of the literature. Eur J Gastroenterol Hepatol. 2010;22:1260-4. PMID: 20671559
27. Lund T, Thomsen SF. Use of TNF-inhibitors and ustekinumab for psoriasis during pregnancy: A patient series. Dermatol Ther. 2017;30:e12454. PMID: 28071837
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
