Tacrolimus Level
Prograf, FK506, Tacrolimus/FK506 Level, Tacrolimus Blood Level, TACRO
Test Codes
EPIC: LAB8760
Department
Toxicology
Specimen Collection Criteria
Collect: One Lavender-top EDTA tube. (Minimum Whole Blood: 2.0 mL)
Do not use Serum Separator Tubes.
Time of Collection: Trough, just prior to next dose.
Physician Office/Draw Specimen Preparation
Do not centrifuge. Refrigerate whole blood in original collection tube prior to transport.
Preparation for Courier Transport
Transport: Refrigerated whole blood in original collection tube. (Minimum: 2.0 mL)
Rejection Criteria
- Serum Separator (SST) tubes.
- Serum or plasma specimens.
In-Lab Processing
Do not centrifuge specimen. Deliver immediately to the appropriate testing station.
Storage
Specimen Stability for Testing:
Room Temperature (20-26°C or 68-78.8°F): 4 hours
Refrigerated (2-8°C or 36-46°F): 3 days
Frozen (-20°C/-4°F or below): 3 months
Specimen Storage in Department Prior to Disposal:
Refrigerated (2-8°C or 36-46°F): 3 days
Frozen (-20°C/-4°F or below): 2 weeks
Laboratory
Royal Oak Toxicology Laboratory
Performed
Sunday – Saturday. Specimens must be received prior to 1:00 pm to be tested the same day.
Reference Range
Therapeutic range (0-3 months post-transplant): 8-16 ng/mL.
Therapeutic range (Greater than 3 months post-transplant): 5-15 ng/mL.
Critical: Greater than 20 ng/mL.
Test Methodology
Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).
This test was developed, and its performance characteristics determined by Beaumont Health. It has not been cleared or approved by the FDA. The Laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes and should not be regarded as investigational or for research.
Interpretation
The following drugs may increase Tacrolimus blood levels: ketoconazole, fluconazole, erythromycin, diltiazem, cimetidine, and methylprednisolone.
The following drugs may decrease Tacrolimus blood levels: carbamazepine, phenobarbital, phenytoin, rifabutin, and rifampin.
Clinical Utility
Tacrolimus is an immunosuppressant drug that has been approved by the FDA for use in liver transplant patients. This assay is used to monitor the therapeutic drug level and evaluate the toxicity of Tacrolimus/ FK506. This assay aids in monitoring changes in blood concentrations resulting from interactions with co-administered drugs. Nephrotoxicity and neurotoxicity are the most significant side effects of tacrolimus.
CPT Codes
80197
LOINC: 11253-2
Contacts
Toxicology Laboratory – RO
248-551-8058
Name: Toxicology Laboratory – RO
Location:
Phone: 248-551-8058
Last Updated
5/15/2025
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