Infliximab
IgG1 monoclonal-antibody against tumor necrosis alpha factor (TNFα) which is used to treat autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
Intravenous administration, initial dose, at 2 and 6 weeks and every 8 weeks
As a matter of fact, because of a very high molecular weight and high plasma protein-binding capacity, it is excreted into breastmilk in an undetectable amount (Mahadevan 2005, Vasiliauskas 2006, Stengel 2008, Kane 2009) or clinically non-significant (Ben-Horn 2011, Fritzsche 2012, Grosen 2014 , Matro 2015).
Plasma levels of infants breastfed by mothers who were treated with Infliximab have resulted to be undetectable or very low (Vasiliauskas 2006, Kane 2009, Fritzsche 2012, Steenholdt 2012).
Neither short nor long-term adverse effects on development, immunological response and/or infection rate, nor altered response to vaccination of infants whose mothers were taking Infliximab have been observed (Mahadevan 2005, Vasiliauskas 2006, Stengel 2008, Kane 2009, Tursi 2010, Puig 2010, Correia 2010 , Fritzsche 2012, Steenholdt 2012).
Because it lacks of oral bioavailability, seems difficult any pass to the infant’s plasma through the ingested breastmilk, except on premature infants and immediate neonatal period, in which there may be an increased intestinal permeability.
Numerous experts and scientific societies of Rheumatology, Gastroenterology and Dermatology consider it to be a very low risk drug, and therefore, compatible while breastfeeding (Mahadevan 2011, Nielsen 2014, Hyrich 2014, Mahadevan 2015, van der Houde 2015, Nguyen 2016, Flint 2016 , Gotestam 2016, Briggs 2017).
Alternatives
We do not have alternatives for Infliximab 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
- cA2
- CenTNF
Writings
- Ινφλιξιμάμπη (Greek)
- إينفليكسيماب (Arabic)
- Инфликсимаб (Cyrillic)
- 英利昔单抗 (Chinese)
- インフリキシマブ (Japanese)
- C6428 H9912 N1694 O1987 S46 (Molecular formula)
- Immunoglobulin G (human-mouse monoclonal cA2 heavy chain anti-human tumor necrosis factor), disulfide with human-mouse monoclonal cA2 light chain, dimer (Chemical name)
- L04AB02 (ATC Code/s)
References
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- 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 Abstract
- Habal FM, Huang VW. Review article: a decision-making algorithm for the management of pregnancy in the inflammatory bowel disease patient. Aliment Pharmacol Ther. 2012 Abstract Full text (link to original source) Full text (in our servers)
- Fritzsche J, Pilch A, Mury D, Schaefer C, Weber-Schoendorfer C. Infliximab and adalimumab use during breastfeeding. J Clin Gastroenterol. 2012 Abstract
- 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 Abstract
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- Miehsler W, Novacek G, Wenzl H, Vogelsang H, Knoflach P, Kaser A, Dejaco C, Petritsch W, Kapitan M, Maier H, Graninger W, Tilg H, Reinisch W; Austrian Society of Gastroenterology and Hepatology. A decade of infliximab: The Austrian evidence based consensus on the safe use of infliximab in inflammatory bowel disease. J Crohns Colitis. 2010 Abstract Full text (in our servers)
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- Gisbert JP. Safety of immunomodulators and biologics for the treatment of inflammatory bowel disease during pregnancy and breast-feeding. Inflamm Bowel Dis. 2010 Abstract
- Pache I, Rogler G, Felley C. TNF-alpha blockers in inflammatory bowel diseases: practical consensus recommendations and a user's guide. Swiss Med Wkly. 2009 Abstract Full text (link to original source) Full text (in our servers)
- Hou JK, Mahadevan U. A 24-year-old pregnant woman with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2009 Abstract
- 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 Abstract
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- Stengel JZ, Arnold HL. Is infliximab safe to use while breastfeeding? World J Gastroenterol. 2008 Abstract
- Weber JC, Kuhnert C. Traitements de fond des affections inflammatoires systémiques au cours de l’allaitement. [Breastfeeding and drug management in connective tissue and rheumatic diseases]. Rev Med Interne. 2008 Abstract
- Østensen M, Motta M. Therapy insight: the use of antirheumatic drugs during nursing. Nat Clin Pract Rheumatol. 2007 Abstract
- Mottet C, Juillerat P, Pittet V, Gonvers JJ, Froehlich F, Vader JP, Michetti P, Felley C. Pregnancy and breastfeeding in patients with Crohn's disease. Digestion. 2007 Abstract
- Heetun ZS, Byrnes C, Neary P, O'Morain C. Review article: Reproduction in the patient with inflammatory bowel disease. Aliment Pharmacol Ther. 2007 Abstract Full text (link to original source) Full text (in our servers)
- Vasiliauskas EA, Church JA, Silverman N, Barry M, Targan SR, Dubinsky MC. Case report: evidence for transplacental transfer of maternally administered infliximab to the newborn. Clin Gastroenterol Hepatol. 2006 Abstract
- Østensen M, Khamashta M, Lockshin M, Parke A, Brucato A, Carp H, Doria A, Rai R, Meroni P, Cetin I, Derksen R, Branch W, Motta M, Gordon C, Ruiz-Irastorza G, Spinillo A, Friedman D, Cimaz R, Czeizel A, Piette JC, Cervera R, Levy RA, et al. Anti-inflammatory and immunosuppressive drugs and reproduction. Arthritis Res Ther. 2006 Abstract Full text (link to original source) Full text (in our servers)
- Tursi A. Effect of intentional infliximab use throughout pregnancy in inducing and maintaining remission in Crohn's disease. Dig Liver Dis. 2006 Abstract
- Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Abstract Full text (link to original source) Full text (in our servers)
- Mahadevan U, Kane S, Sandborn WJ, Cohen RD, Hanson K, Terdiman JP, Binion DG. Intentional infliximab use during pregnancy for induction or maintenance of remission in Crohn's disease. Aliment Pharmacol Ther. 2005 Abstract