Adalimumab use while Breastfeeding
Drugs containing Adalimumab: Humira
Adalimumab Levels and Effects while Breastfeeding
Summary of Use during Lactation
Limited information indicates that maternal adalimumab injections produce low levels in milk and do not adversely affect the nursing infant. Because adalimumab is a large protein molecule with a molecular weight of about 148,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Most experts feel that the drug is probably safe during nursing. However, until more data become available, adalimumab should be used with caution while nursing a newborn or preterm infant.
Maternal Levels. One woman received a single 40 mg of adalimumab subcutaneously at 4 weeks postpartum. Milk samples were obtained every 2 days for 8 days. A peak milk adalimumab level of 31 mcg/L was detected on day 6 after injection. Milk levels on days 5 and 8 were about 10 mcg/L.
Two women received adalimumab 40 mg subcutaneously for treatment of inflammatory bowel disease at unstated intervals. The first woman received the drug during pregnancy and postpartum. At 21 weeks postpartum and 7 days after the previous dose, her breastmilk adalimumab was 4.83 mcg/L while her serum level was 6.7 mg/L. In the second woman, the milk adalimumab concentration at 8 weeks postpartum and 9 days after the last dose was 4.88 mcg/L with a simultaneous serum concentration of 5.5 mg/L.
Six women who received adalimumab (dose unspecified) as part of a large registry study submitted breastmilk samples. Adalimumab was not detected in any samples between 12 and 24 hours after infusion.
Infant Levels. A woman received adalimumab 40 mg subcutaneously at unstated intervals while breastfeeding (extent not stated). At 8 weeks postpartum and 9 days after the prior dose, the infant had an undetectable (<0.65 mcg/L) adalimumab serum concentration.
A pregnant woman received adalimumab 40 mg every 2 weeks for Crohn's disease until week 16 of pregnancy. Her infant was exclusively breastfed until 4 months of age and the drug was reinstituted on day 24 postpartum. At 3 months of age, adalimumab was undetectable in the infant's serum.
Effects in Breastfed Infants
One woman with Crohn's disease received adalimumab 40 mg subcutaneously every week during pregnancy and breastfeeding (extent not stated). Her infant demonstrated normal growth and development at 6 months of age. The authors reported a brief follow-up stating that the woman also breastfed her second infant during adalimumab therapy with no adverse consequences.
Another woman with Crohn's disease received adalimumab 40 mg subcutaneously every 2 weeks during pregnancy and breastfeeding (extent not stated). Her infant demonstrated normal growth and development at 6 months of age.
Two women nursed their infants (extent not stated) while receiving adalimumab 40 mg subcutaneously at unstated intervals for inflammatory bowel disease. They breastfed for at least 21 weeks and 8 weeks, respectively, but the total duration was not stated. At 14.5 and 15 months of age, respectively, neither infant had any signs of adverse drug reactions, allergic reactions or severe infections leading to hospitalization. Developmental milestones were reached on time by both infants.
A pregnant woman received adalimumab 40 mg every 2 weeks for Crohn's disease until week 16 of pregnancy. Her infant was exclusively breastfed until 4 months of age and the drug was reinstituted on day 24 postpartum. At 7 months of age, the infant was healthy with normal growth and development. The infant had no infections requiring antibiotics or hospitalization.
A prospective cohort study followed pregnant women with inflammatory bowel disease throughout pregnancy and for 12 months postpartum. Women were assigned to one of the following groups: unexposed (no thiopurines or anti-TNF agents); group A (azathioprine or mercaptopurine); group B (infliximab, adalimumab or certolizumab) and group AB (both a thiopurine and an anti-TNF agent). Of 1052 women enrolled in the study, 72% breastfed their infants, although the extent and duration were not stated in the abstract. A total of 102 women were exposed to an anti-TNF agent and 59 were exposed to a thiopurine plus an anti-TNF agent. The use of an anti-TNF alone was not associated with any complication in the infants and their growth and development were normal throughout the 12 months. Infants exposed to both a thiopurine and an anti-TNF agent had a 50% increase in the number of infections between 9 and 12 months of age. The relationship of this increase with breastfeeding could not be determined from the available data.
A case-control study compared infant outcomes between infants exposed to adalimumab or etanercept during pregnancy (n = 25) to those not exposed (n = 25). Three infants were exposed to one of the drugs during pregnancy and breastfeeding and 2 were exposed during breastfeeding only. No relevant infectious diseases nor post-vaccine complications were noted in the 5 infants exposed during lactation.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
1. Gisbert JP, Chaparro M. Safety of anti-TNF agents during pregnancy and breastfeeding in women with inflammatory bowel disease. Am J Gastroenterol. 2013;108:1426-38. PMID: 23752881
2. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014;11:116-27. PMID: 23897285
3. Mahadevan U, Matro R. Care of the pregnant patient with inflammatory bowel disease. Obstet Gynecol. 2015;126:401-12. PMID: 26241432
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. 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. PMID: 26888948
8. Ben-Horin S, Yavzori M, Katz L et al. Adalimumab level in breast milk of a nursing mother. Clin Gastroenterol Hepatol. 2010;8:475-6. PMID: 20005982
9. Fritzsche J , Pilch A, Mury D et al. Infliximab and adalimumab use during breastfeeding. J Clin Gastroenterol. 2012;46:718-9. PMID: 22858514
10. Matro R, Martin CF, Wolf DC et al. Detection of biologic agents in breast milk and implication for infection, growth and development in infants born to women with inflammatory bowel disease: Results from the PIANO registry. Gastroenterology. 2015;148:S141. Abstract.
11. Julsgaard M , Brown S, Gibson P, Bell S. Adalimumab levels in an infant. J Crohns Colitis. 2013;7:597-8. PMID: 23102835
12. Vesga L, Terdiman JP, Mahadevan U. Adalimumab use in pregnancy. Gut. 2005;54:890. PMID: 15888806
13. Mahadevan U. Pregnancy, fertility and therapies for IBD. Gastroenterol Hepatol. 2006;2:234-6.
14. Mishkin DS, Van Deinse W, Becker JM, Farraye FA. Successful use of adalimumab (Humira) for Crohn's disease in pregnancy. Inflamm Bowel Dis. 2006;12:827-8. PMID: 16917239
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 . Gastroenterology. 2012;142 (Suppl 1):S149. Abstract 865. DOI: doi.org/10.1016/S0016-5085(12)60561-7
16. Reggia R, Andreoli L, Bazzani C et al. Longterm follow-up of children born to mothers with chronic arthritides and exposed to anti-TNF alfa agents during pregancy and breastfeeding: A case-control study. Arthritis Rheumatol. 2015;67 (Suppl. 10):Abstract 2524. http://acrabstracts.org/abstract/longterm-follow-up-of-children-born-to-mothers-with-chronic-arthritides-and-exposed-to-anti-tnf-alfa-agents-during-pregancy-and-breastfeeding-a-case-control-study/
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Antibodies, Monoclonal, Humanized
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