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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.