Adalimumab

Drug Levels and Effects:




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 little is excreted into breastmilk and is not likely to be absorbed, some experts feel that the drug is probably safe during nursing.[1][2][3][4] However, until more data become available, an alternative drug may be preferred, especially 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.[5]

Two mothers received adalimumab 40 mg subcutaneously for inflammatory bowel disease. Breastmilk infliximab was 200 mcg/L in one mother (time after dose not stated), which was about 4.3% of her serum concentration. The second mother began infliximab at 3 months postpartum. Her breastmilk infliximab levels were 94.6 mcg/L on day 1 after the first dose and 119.7 mcg/L on day 4 after the dose.[6]

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.[6]

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.[6]


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.[7] The authors reported a brief follow-up stating that the woman also breastfed her second infant during adalimumab therapy with no adverse consequences.[1]

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.[8]

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.[6]


Possible Effects on Lactation:


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


Alternate Drugs to Consider:


Etanercept,Infliximab


References:


1. Mahadevan U. Pregnancy, fertility and therapies for IBD. Gastroenterol Hepatol. 2006;2:234-6.
2. Skomsvoll JF, Wallenius M, Koksvik HS et al. Drug Insight: anti-tumor necrosis factor therapy for inflammatory arthropathies during reproduction, pregnancy and lactation . Nature Clin Pract Rheumatol. 2007;3:156-64. PMID:17334338
3. Ostensen M. Management of early aggressive rheumatoid arthritis during pregnancy and lactation. Expert Opin Pharmacother. 2009;10:1469-79. PMID:19505214
4. van der Woude CJ, Kolacek S, Dotan I et al. European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohn's Colitis. 2010;4:493-510. PMID:21122553
5. Ben-Horin S, Yavzori M, Katz L et al.Adalimumablevel in breast milk of a nursing mother. Clin Gastroenterol Hepatol. 2010;8:475-6. PMID:20005982
6. Fritzsche J , Pilch A, Mury D et al. Infliximab and adalimumab use during breastfeeding. J Clin Gastroenterol. 2012;46:718-9. PMID:22858514
7. Vesga L, Terdiman JP, Mahadevan U.Adalimumabuse in pregnancy. Gut. 2005;54:890. PMID:15888806
8. 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



Substance Identification:




Substance Name:

Adalimumab

CAS Registry Number:

331731-18-1

Drug Class:


  • Antibodies, Monoclonal, Humanized

  • Antirheumatic Agents

  • Dermatologic Agents

  • Gastrointestinal Agents


  • Administrative Information:




    LactMed Record Number:


    513


    Last Revision Date:


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