Summary of Use during Lactation

The amounts of upadacitinib in breastmilk are low, but no information is available on the clinical use of upadacitinib during breastfeeding. Until more data become available, upadacitinib should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Expert opinion considers breastfeeding to be unadvisable during tofacitinib use at this time.[1-4] The manufacturer recommends that breastfeeding be withheld for 6 days after the last dose.

Drug Levels

Maternal Levels. Forty breastmilk samples were obtained from 4 women taking either 30 mg (n = 2) or 45 mg (n = 2) daily of upadacitinib. Three of the women had a sufficient number of samples over a 24-hour period to calculate the RID on that day, with 2 of them having a sufficient number on two separate days. The daily RID values were 6.5% and 9.6% in patient 1, 5.7% in patient 2, and 3.8% and 6.1% in patient 3. Individual single-point RIDs of patient 4 fell within the range of the other patients. When all 40 single-point RID values from the 4 women were considered, the median RID was 2.66% (IQR 0.75% to 10.58%). The daily infant dosages were calculated to range from 3.8 to 59.7 mcg/kg. It is unclear why there was such a large range of milk levels, RID values, and infant dosages.[4]

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

Effects in Breastfed Infants

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

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

(Rheumatoid Arthritis) Adalimumab, Certolizumab Pegol, Etanercept, Infliximab, Tocilizumab

References

1.

Selinger C, Laube R, Limdi JK, et al. Appropriateness of small molecule agents for patients with IBD of childbearing age - a RAND/UCLA appropriateness panel. Therap Adv Gastroenterol 2024;17:17562848241299737. [PMC free article: PMC11558739] [PubMed: 39539488]

2.

Rüegg L, Pluma A, Hamroun S, et al. EULAR recommendations for use of antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. Ann Rheum Dis 2025;84:910–26. [PubMed: 40287311]

3.

Mahadevan U, Seow CH, Barnes EL, et al. Global consensus statement on the management of pregnancy in inflammatory bowel disease. Clin Gastroenterol Hepatol 2025;23 (11S):S1–S60. [PubMed: 40874901]

4.

Duricova D, Sonnenberg E, Augustijns P, et al. Upadacitinib in mother with inflammatory bowel disease: Placental transfer and breast milk excretion. Clin Gastroenterol Hepatol 2026;24:1179–81.e1. [PubMed: 40571170]

Substance Name

Upadacitinib

CAS Registry Number

1310726-60-3

Drug Class

Breast Feeding

Lactation

Milk, Human

Enzyme Inhibitors

Protein Kinase Inhibitors

Signal Transduction Inhibitors

Janus Kinase Inhibitors

JAK Inhibitors