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Test Catalog

Test ID: TACPK    
Tacrolimus, Peak, Blood

Useful For Suggests clinical disorders or settings where the test may be helpful

Assessment of postdosing (peak) blood tacrolimus concentrations

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Tacrolimus (Prograf) is a macrolide antibiotic derived from the fungus Streptomyces tsukubaenesis. Like cyclosporine, tacrolimus inhibits calcineurin to suppress T cells. Tacrolimus is metabolized by CYP3A4; thus, its concentration is affected by drugs that inhibit (calcium channel blockers, antifungal agents, some antibiotics, grapefruit juice) or induce (anticonvulsants, rifampin) this enzyme. Tacrolimus has a narrow therapeutic range and adverse effects are common, particularly at high dose and concentrations, making therapeutic drug monitoring essential.

 

Since 90% of tacrolimus is in the cellular components of blood, especially erythrocytes, whole blood is the preferred specimen for analysis of trough concentrations. Target steady-state concentrations vary depending on clinical protocol, the presence or risk of rejection, time from transplant, type of allograft, concomitant immunosuppression, and side effects (mainly nephrotoxicity). Optimal trough blood concentrations are generally between 5.0 and 15.0 ng/mL. Higher levels are often sought immediately after transplant, but as organ function stabilizes at about 4 weeks from transplant, doses are generally reduced in solid organ transplant patients who are stable. Trough concentrations should be maintained below 20 ng/mL.

 

Optimal postdose sampling strategies and blood concentrations have not been well established for tacrolimus. A study of 54 liver transplant patients suggested that most individuals have tacrolimus blood concentrations ranging between 5.0 and 30.0 ng/mL in samples drawn 1 to 4 hours after dosing, although some patients showed slightly higher blood concentrations at 1-hour postdose.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

5.0-30.0 ng/mL

 

Target steady-state trough concentrations vary depending on the type of transplant, concomitant immunosuppression, clinical/institutional protocols, and time posttransplant. Results should be interpreted in conjunction with this clinical information and any physical signs or symptoms of rejection or toxicity.

Interpretation Provides information to assist in interpretation of the test results

This test measures postdose levels of tacrolimus. Established reference ranges reflect trough measurement, and are not applicable to samples drawn after dosing. No reference ranges or standard sampling protocols have been established for postdosing tacrolimus levels, but a limited study of liver transplant recipients suggests most patients will show postdose tacrolimus levels ranging from 5.0 to 30.0 ng/mL when drawn 1 to 4 hours after dosing. The narrow therapeutic window and high individual pharmacokinetic variability of tacrolimus make regulation of dose by blood concentrations essential. Since 90% of the drug is in the cellular components of blood, especially erythrocytes, whole blood, rather than plasma, concentrations are measured and correlate better with efficacy and toxicity.

 

This assay is specific for tacrolimus; it does not cross-react with cyclosporine, cyclosporine metabolites, sirolimus, sirolimus metabolites, or tacrolimus metabolites. Results by liquid chromatography with detection by tandem mass spectrometry (LC-MS/MS) are approximately 30% less than by immunoassay.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Established (trough) tacrolimus reference ranges do not apply to samples drawn after administration of a dose. Order TACRO / Tacrolimus, Blood, for trough samples.

Clinical Reference Recommendations for in-depth reading of a clinical nature

1. Kahan BD, Keown P, Levy GA, et al: Therapeutic drug monitoring of immunosuppressant drugs in clinical practice. Clin Ther 2002 March;24(3):330-350

2. Scott LJ, McKeage K, Keam SJ, et al: Tacrolimus: a further update of its use in the management of organ transplantation. Drugs 2003;63(12):1247-1297