Is Upadacitinib safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Upadacitinib. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
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.
Effects on the breastfed infant
Relevant published information was not found as of the revision date.
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
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.
Alternatives LactMed lists
“No published information” means the studies do not exist yet — not that Upadacitinib is known to be harmful, and not that it is known to be safe. Your prescriber or pharmacist can weigh your baby's age and whether a better-studied alternative would do the same job. Worth asking before stopping a medicine you need.
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Upadacitinib” (upadacitinib). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.