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HelpTest ID CYCPK Cyclosporine, Peak, Blood
Useful For
Monitoring whole blood peak cyclosporine concentration during therapy, particularly in individuals coadministered cytochrome P450 (CYP) 3A4 substrates, inhibitors, or inducers
Adjusting dose to optimize immunosuppression while minimizing toxicity
Evaluating patient compliance
Method Name
Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)
Reporting Name
Cyclosporine, Peak, BSpecimen Type
Whole Blood EDTAOrdering Guidance
This test is for specimens collected during a peak period. For specimens collected at trough, order CYCSP / Cyclosporine, Blood.
Necessary Information
Date of last dose, time of last dose, and dosage information are required.
Specimen Required
Container/Tube: Lavender top (EDTA)
Specimen Volume: 3 mL
Collection Instructions:
1. Do not centrifuge.
2. Send whole blood specimen in original tube. Do not aliquot.
Additional Information: No definitive therapeutic or toxic ranges have been established for this peak testing.
Specimen Minimum Volume
1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Whole Blood EDTA | Refrigerated (preferred) | 14 days | |
| Ambient | 14 days | ||
| Frozen | 14 days |
Reject Due To
| Gross hemolysis | OK |
| Gross lipemia | OK |
| Gross icterus | OK |
| Clotted specimen | Reject |
Clinical Information
Cyclosporine is a lipophilic polypeptide used to prevent rejection after solid organ transplantation; it suppresses T-cell activation by inhibiting calcineurin to decrease interleukin-2 (IL-2) production. There is substantial interpatient variability in absorption, half-life, and other pharmacokinetic parameters. Cyclosporine is extensively metabolized by cytochrome P450 (CYP) 3A4 to at least 30 less-active metabolites, many of which are detected by immunoassays. Cyclosporine is known for many drug interactions, including increased neuro- and nephrotoxicity when coadministered with antibiotics, antifungals, or other immunosuppressants. Cyclosporine has a narrow therapeutic range with frequent adverse effects making therapeutic drug monitoring essential. With 80% of cyclosporine sequestered in erythrocytes, whole blood is the preferred specimen for analysis.
Reference Values
No definitive therapeutic or toxic ranges have been established.
Optimal blood drug levels are influenced by type of transplant, patient response, time posttransplant, coadministration of other drugs, and drug formulation.
The following 2-hour postdose cyclosporine ranges are only suggested guidelines:
Kidney transplant: 800-1700 ng/mL
Liver transplant: 600-1000 ng/mL
Target steady-state peak 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/symptoms of rejection/toxicity.
Interpretation
No definitive therapeutic or toxic ranges have been established for postdose peak monitoring. Preferred therapeutic ranges may vary by transplant type, protocol, and comedications. The 2-hour postdose cyclosporine ranges listed for this test are only suggested guidelines.
This assay is specific for cyclosporine; it does not cross-react with cyclosporine metabolites, sirolimus, sirolimus metabolites, tacrolimus, or tacrolimus metabolites. Results by liquid chromatography with detection by tandem mass spectrometry are approximately 30% less than by immunoassay.
Cautions
Established (trough) cyclosporine reference ranges do not apply to specimens collected after administration of a dose. For trough specimens, order CYCSP / Cyclosporine, Blood.
Clinical Reference
1. Milone MC, Shaw LM. Therapeutic drugs and their management. In: Rifai N, Chiu RWK, Young I, Burnham CAD, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:420-453
2. Moyer TP, Post GR, Sterioff S, Anderson CF. Cyclosporine nephrotoxicity is minimized by adjusting dosage on the basis of drug concentration in blood. Mayo Clin Proc. 1988;63(3):241-247
3. Kahan BD, Keown P, Levy GA, Johnston A. Therapeutic drug monitoring of immunosuppressant drugs in clinical practice. Clin Ther. 2002;24(3):330-350
4. Dunn CJ, Wagstaff AJ, Perry CM, Plosker GL, Goa KL. Cyclosporin: an updated review of the pharmacokinetic properties, clinical efficacy, and tolerability of a microemulsion-based formulation (neoral) 1 in organ transplantation. Drugs. 2001;61(13):1957-2016
Method Description
Blood specimens are subjected to protein precipitation. The resulting supernatant is analyzed by liquid chromatography tandem mass spectrometry.(Bjergum MW, Jannetto PJ, Langman LJ. Simultaneous determination of tacrolimus and cyclosporine A in whole blood by ultrafast LC-MS/MS. Methods Mol Biol. 2019;1872:111-118. doi:10.1007/978-1-4939-8823-5_11)
Day(s) Performed
Monday through Sunday
Report Available
Same day/1 to 2 daysTest Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
80158
NY State Approved
YesForms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-Renal Diagnostics Test Request (T830)
-Therapeutics Test Request (T831)