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Adalimumab use while Breastfeeding

Drugs containing Adalimumab: Humira, Amjevita, Hyrimoz, Cyltezo

Medically reviewed by Drugs.com. Last updated on Jul 12, 2018.

Adalimumab Levels and Effects while Breastfeeding

Summary of Use during Lactation

Limited information indicates that maternal adalimumab injections produce low levels in breastmilk and do not adversely affect the nursing infant. Because adalimumab is a large protein molecule with a molecular weight of about 148,000, 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.[1][2][3][4][5][6][7][8] However, until more data become available, adalimumab should be used with caution while nursing a newborn or preterm infant.

Drug Levels

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.[9]

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.[10]

In a multi-center study of women with inflammatory bowel disease in pregnancy (the PIANO registry), 21 women receiving adalimumab provided milk samples at 1, 12, 24, and 48 hours after drug administration. Some also provided samples at 72, 96, 120, and 168 hours after drug administration. Two of the women had detectable (>0.01 mg/L) adalimumab levels in milk. Peak concentrations in breastmilk were 0.45 and 0.71 mg/L and occurred at 12 to 24 hours after the dose. Seven women had undetectable milk adalimumab levels over a week of monitoring.[8]

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.[10]

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.[11]

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.[12] The authors reported a brief follow-up stating that the woman also breastfed her second infant during adalimumab therapy with no adverse consequences.[13]

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.[14]

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.[10]

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.[11]

A case-control study of women with chronic arthritic conditions found 2 women who received adalimumab during pregnancy and lactation (extent not stated). No differences were observed in the 2 infants' growth parameters, developmental milestones, vaccinations and diseases in the first year of life compared to those not exposed to the drugs with lactation.[15]

A woman receiving adalimumab for severe psoriasis breastfed 2 infants following 2 pregnancies. No adverse effects were reported in the infant, although the dosage of adalimumab and the extent of breastfeeding were not reported.[16]

In a multi-center study of women with inflammatory bowel disease in pregnancy (the PIANO registry), 99 women received adalimumab while breastfeeding their infants. Among those who received adalimumab or another biologic agent while breastfeeding, infant growth, development or infection rate was no different from infants whose mothers received no treatment. An additional 68 women received a biologic agent plus a thiopurine. Infant outcomes were similar in this group.[8]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

(Inflammatory Bowel Disease) Certolizumab Pegol, Infliximab, (Psoriasis) Etanercept, Infliximab, Phototherapy, Tretinoin, (Rheumatoid Arthritis) Certolizumab Pegol, Etanercept, Infliximab

References

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. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. Fritzsche J, Pilch A, Mury D et al. Infliximab and adalimumab use during breastfeeding. J Clin Gastroenterol. 2012;46:718-9. PMID: 22858514

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. Dall'ara F, Reggia R, Bazzani C et al. Safety of anti-TNF alfa agents during pregancy and breastfeeding: longterm follow up of exposed children in a case-series of mothers with chronic arthritides. Ann Rheum Dis. 2016;75 (Suppl 2):493. Abstract. DOI: doi:10.1136/annrheumdis-2016-eular.4123

16. Lund T, Thomsen SF. Use of TNF-inhibitors and ustekinumab for psoriasis during pregnancy: A patient series. Dermatol Ther. 2017;30:e12454. PMID: 28071837

Adalimumab Identification

Substance Name

Adalimumab

CAS Registry Number

331731-18-1

Drug Class

Breast Feeding

Lactation

Antibodies, Monoclonal, Humanized

Antirheumatic Agents

Dermatologic Agents

Gastrointestinal Agents

Anti-Inflammatory Agents

Administrative Information

LactMed Record Number

513

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Further information

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