Can I take adalimumab while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. Clinical data are available from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry in pregnant women with rheumatoid arthritis (RA) or Crohn’s disease (CD) treated with adalimumab. Registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with RA or CD and a rate of 7.5% for major birth defects in the disease-matched comparison cohort. The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects ( see Data ).

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Adalimumab (subcutaneous), Sandoz Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

This quote is from the subcutaneous formulation label.

Maternal adalimumab injections produce low levels in breastmilk. Because adalimumab is a large protein molecule, it is likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[1] Adalimumab was undetectable in the serum of some breastfed infants and adalimumab does not adversely affect the development of breastfed infants or increase the risk of infections. Waiting for at least 2 weeks postpartum to resume therapy suspended during pregnancy may minimize transfer to the infant.[2] However, in infants of mothers who received adalimumab during late pregnancy, continued use while breastfeeding does not prolong adalimumab elimination by the infant.[3] Numerous experts and professional guidelines have stated that adalimumab is a low risk to the nursing infant and acceptable to use during breastfeeding.[4-10] Anti-TNF agents reduce the levels of tumor necrosis factor and IP-10 in the milk of mothers with inflammatory bowel disease in the early postpartum period.[11] This reduction in TNF might lead to decreased milk production, so extra lactation support might be necessary in women taking adalimumab.

“Summary of Use during Lactation”, LactMed record “Adalimumab” (LM513), quoted verbatim. Everything LactMed reports about Adalimumab while breastfeeding.

8.2 Lactation Risk Summary Limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. Published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. However, the effects of local exposure in the gastrointestinal tract are unknown. There are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Adalimumab-adaz and any potential adverse effects on the breastfed child from Adalimumab-adaz or from the underlying maternal condition.

Prescribing label, section “8.2 Lactation”: Adalimumab (subcutaneous), Sandoz Inc. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

This quote is from the subcutaneous formulation label.