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Updated: May 15, 2026

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
Published on: November 8, 2015
Interpreting tacrolimus concentrations during pregnancy and postpartum.
Mary F Hebert1, Songmao Zheng, Karen Hays
1Department of Pharmacy, University of Washington, Seattle, WA 98195-7630, USA.
Tacrolimus levels during pregnancy are hard to interpret due to pharmacokinetic changes. Monitoring unbound tacrolimus may improve safety for pregnant transplant recipients.
Area of Science:
- Immunology
- Pharmacology
- Obstetrics
Background:
- Solid organ transplantation success is increasing, but pregnancy poses high risks.
- Tacrolimus pharmacokinetics change significantly during pregnancy, complicating dosage monitoring.
- Factors like anemia and hypoalbuminemia can increase unbound tacrolimus levels, risking toxicity.
Purpose of the Study:
- To analyze tacrolimus pharmacokinetic changes during pregnancy.
- To evaluate the challenges in monitoring tacrolimus therapy in pregnant transplant recipients.
- To assess fetal and neonatal outcomes in pregnancies involving tacrolimus use.
Main Methods:
- Review of tacrolimus pharmacokinetics in pregnant solid organ transplant recipients.
- Analysis of factors affecting unbound tacrolimus concentrations.
- Examination of placental transfer and neonatal effects of tacrolimus.
Main Results:
- Whole blood tacrolimus trough concentrations are challenging to interpret during pregnancy.
- Anemia and hypoalbuminemia can lead to elevated unbound tacrolimus concentrations.
- Tacrolimus crosses the placenta, but fetal levels are lower than maternal levels.
- No congenital malformations linked to tacrolimus, but reversible neonatal nephrotoxicity and hyperkalemia can occur.
- Minimal tacrolimus transfer into breast milk, posing low risk to nursing infants.
Conclusions:
- Clinical management of tacrolimus in pregnant transplant patients requires careful consideration of unbound drug levels.
- Monitoring unbound tacrolimus may be more clinically relevant than whole blood trough concentrations in pregnancy.
- Tacrolimus appears relatively safe in pregnancy, with low risk to newborns and nursing infants, despite pharmacokinetic challenges.
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