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DOI: 10.1055/s-0038-1647092
Low Transfer of Tacrolimus and Its Metabolites into Colostrum of Graft Recipient Mothers
Publication History
Publication Date:
27 April 2018 (online)
Introduction: The number of neonates born to organ-recipient transplanted mothers on chronic immunosuppressive therapy is increasing worldwide. Currently, there are no recommendations about the optimal feeding strategies for such offsprings. Recently, growing evidence suggests that breastfeeding might be possible and beneficial also in these infants. We designed a study aiming at assessing the transfer of tacrolimus into colostrum of posttransplant breastfeeding mothers.
Materials and Methods: We enrolled mother–infants pairs, and we assessed the amount of tacrolimus and its metabolites, M-1 and M-3, that would be ingested by each breastfed neonate. Concentrations of tacrolimus and its metabolites were measured in colostrum from posttransplant mothers as well as in venous cord blood and venous blood of the neonates. Test material analysis was performed by liquid chromatography coupled with mass spectrometry (LC/MS). The amount of ingested formula milk was registered which allowed for estimation of amount of tacrolimus and its metabolites that would have been ingested by breastfed infants.
Results: Fourteen posttransplant mothers with their neonates were studied. The mean amount of tacrolimus that would be ingested by the neonates in maternal milk was 151.4 ng/kg/24 h (SD ± 74.39); metabolite M-1: 23.80 ng/kg/24 h (SD ± 14.53); and metabolite M-3: 13.25 ng/kg/24 h (SD ± 9.05). The peak level of tacrolimus and metabolite M-1 in colostrum was noted 8 hours after an oral dose (3.219 ng/mL [SD ± 2.22] and 0.56 ng/mL [SD ± 0.60], respectively) and metabolite M-3 after 6 hours (0.29 ng/mL [SD ± 0.22]).
Conclusion: The low concentrations of tacrolimus and its metabolites, M-1 and M-3, in colostrum suggest that neonates will ingest trace amounts of the drug, thus vouching for probable safety of breastfeeding in these infants.
Keywords: prematurities, breastfeeding, transplantation, drug safety