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Cyclosporine A

Neoral, Sandimmune

Test Codes

Cyclosporine A: EPIC: LAB5385, SOFT: CYCLO, Cyclosporine Level 2: EPIC: LAB5386, SOFT: CYCL2

Department

Toxicology

Specimen Collection Criteria

Collect: One Lavender-top EDTA tube. (Minimum Whole Blood: 3.0 mL)

Do not use Serum Separator Tubes.
Time of Collection: Trough, just prior to next dose.

Physician Office/Draw Specimen Preparation

Do not centrifuge. Maintain whole blood in original collection tube at room temperature (20-26°C or 68-78.8°F) prior to transport.

Preparation for Courier Transport

Transport: Whole blood in original collection tube at room temperature (20-26°C or 68-78.8°F). (Minimum: 3.0 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): 24 hours
Refrigerated (2-8°C or 36-46°F): 7 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 p.m. to be tested the same day.

Reference Range

Time Post-Transplant	Target Concentration (ng/mL)
0-3 months	200-400
3-12 months	100-300
Greater than 1 year	100-200

 

Blood drawn at other times will yield higher results. This test may also be used to anaylyze cyclosporine levels 2 hours after dosing (C2 concentrations); trough therapeutic ranges do not apply to C2 specimens.

Critical: Greater than 400 ng/mL.

Trough critical level does not apply to C2 specimens.

This test may also be used to analyze cyclosporine levels 2 hours after dosing (C2 concentrations); critical level for C2 concentrations is reater than 1200 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

Cyclosporine is metabolized in the liver and gut by cytochrome P450 3A4. Drugs that inhibit CYP3A4 will increase Cyclosporine levels. These include: calcium channel blockers, Ketoconazole, Fluconazole, Erythromycin, Methyl prednisolone, Allopurinol, Danazol, and Metoclopramide.

Drugs that have been reported to decrease the whole blood concentration of Cyclosporine include: Rifampin, Phenytoin, Phenobarbital, I.V. Trimethoprim with Sulfamethoxazole, and Carbamazepine.

Prednisolone clearance is reduced in patients treated with Cyclosporine.

Clinical Utility

Cyclosporine appears to affect the metabolism of both T-helper lymphocytes and T-suppressor lymphocytes, which, in turn suppresses the immune system. Cyclosporine is used to prevent the rejection of new organ transplants. Transplant patients are exposed to Cyclosporine and other immunosuppressants for the rest of their lives. They are susceptible to nephro-, hepato- and neurotoxicity in association with high blood levels of this drug and extended period of exposure. Absorption and metabolism of Cyclosporine varies from patient to patient. Dosages must be individualized and monitored to achieve optimal immunosuppression and minimize adverse side effects. This assay is used to monitor Cyclosporine levels in whole blood. It aids in the maintenance of proper therapeutic dosing and helps to prevent toxicity in heart, kidney, liver or combined transplant patients receiving Cyclosporine.

CPT Codes

80158
LOINC: 55805-6, 32997-9

Contacts

Last Updated

1/26/2023