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Ann Pharmacother. 2003 Jun;37(6):815-8.

Milk transfer and neonatal safety of tacrolimus.

Author information

  • 1The Motherisk Program, Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children and The University of Toronto, Toronto, Ontario, Canada.

Abstract

OBJECTIVE:

To report the first case of tacrolimus measurement in human milk following maternal dosing in a woman who breast-fed while taking the medication.

CASE REPORT:

A 32-year-old white woman who had taken tacrolimus 0.1 mg/kg/d throughout pregnancy contacted the Motherisk Program at 35 weeks' gestation inquiring about the safety of breast-feeding during maternal tacrolimus therapy. After benefit-risk assessment, the mother decided to breast-feed the baby.

METHODS:

Manually expressed milk samples were collected over 12 hours following the first tacrolimus dose of the day; pre-dosing and 1-hour post-dosing blood concentrations were also determined. The samples were analyzed for tacrolimus by tandem-mass spectrometry. Breast milk and blood samples were collected at steady-state.

RESULTS:

The highest and mean concentrations of tacrolimus in milk were 0.57 and 0.429 ng/mL, respectively. From these measurements, the exclusively breast-fed infant would ingest, on average, 0.06 micro g/kg/d, which corresponds to 0.06% of the mother's weight-adjusted dose. Given the low oral bioavailability of tacrolimus, the maximum amount the baby would receive is 0.02% of the mother's weight-adjusted dose. The milk-to-blood ratios of tacrolimus at pre-dosing and 1-hour post-dosing concentrations were calculated to be 0.08 and 0.09, respectively. At 2.5 months of age, the infant was developing well both physically and neurologically.

COMMENT:

This report is the first to measure tacrolimus concentrations in established human milk using tandem-mass spectrometry to detect drug while the infant was exclusively breast-fed by the mother, and in which the infant's growth and development were reported.

CONCLUSIONS:

Our results suggest that maternal therapy with tacrolimus for liver transplant may be compatible with breast-feeding.

PMID:
12773068
[PubMed - indexed for MEDLINE]
PMCID:
PMC3636979
Free PMC Article
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