Abstract
BACKGROUND AND OBJECTIVES: Women have traditionally been advised not to breastfeed while taking tacrolimus, based on theoretical risks of neonatal immunosuppression and assumed secretion into breast milk, rather than clinical data suggesting neonatal absorption. The aim of this study was to assess tacrolimus levels in breast milk and neonatal exposure during breastfeeding. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: An observational cohort study was performed in two tertiary referral high-risk obstetric medicine clinics. Fourteen women taking tacrolimus during pregnancy and lactation, and their 15 infants, 11 of whom were exclusively breast-fed, were assessed. Tacrolimus levels were analyzed by liquid chromatography-tandem mass spectrometry. Samples from mothers and cord blood were collected at delivery and from mothers, infants, and breast milk postnatally where possible. RESULTS: All infants with serial sampling had a decline in tacrolimus level, which was approximately 15% per day (ratio of geometric mean concentrations 0.85; 95% confidence interval, 0.82-0.88; P<0.001). Breast-fed infants did not have higher tacrolimus levels compared with bottle-fed infants (median 1.3 μg/L [range, 0.0-4.0] versus 1.0 μg/L [range, 0.0-2.3], respectively; P=0.91). Maximum estimated absorption from breast milk is 0.23% of maternal dose (weight-adjusted). CONCLUSIONS: Ingestion of tacrolimus by infants via breast milk is negligible. Breastfeeding does not appear to slow the decline of infant tacrolimus levels from higher levels present at birth. Women taking tacrolimus should not be discouraged from breastfeeding if monitoring of infant levels is available.