Cyclosporine, Whole Blood

CPT: 80158
Updated on 11/10/2017
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Test Details

Synonyms

  • Gengraf®
  • Neoral®
  • Restasis®
  • Sandimmune®

Methodology

Liquid chromatography/tandem mass spectrometry (LC/MS-MS)

Reference Interval

Therapeutic: 100−400 ng/mL. The recommended therapeutic ranges by donor organ are as follows:

• Renal transplant: 100−250 ng/mL

• Liver transplant: 100−400 ng/mL

• Cardiac transplant: 100−400 ng/mL

• Bone marrow transplant: 200−300 ng/mL

Additional Information

Cyclosporine is an immunosuppressive agent derived from Tolypocladium inflatum gams, a fungus originally isolated from a Norwegian soil sample. The agent is used extensively to control rejection of organ transplants, especially of liver, heart, or kidney. The effectiveness of cyclosporine results from specific and reversible inhibition of immunocompetent lymphocytes in the G0 and G1 phase of the cell cycle. T-lymphocytes are preferentially inhibited. The T-helper cell is the main target, although the T-suppressor cell may also be suppressed. Cyclosporine also inhibits lymphokine production and release, including interleukin-2.

Monitoring blood levels is imperative because the pharmacokinetics of cyclosporine are not only complex but vary over time in the same patient; thus, blood levels cannot be well predicted from dosing schedules. Furthermore, this drug has a narrow therapeutic window and significant toxicity at levels above that range.

Renal toxicity with eventual renal failure is the most severe complication. Other assays to assess renal function (ie, BUN, creatinine clearance) should be ordered along with cyclosporine level, since toxicity may begin even with “acceptable” blood levels. Other toxicities include hypertension, convulsions, tremors, pulmonary edema, and an increased risk of lymphoma.

Drugs that enhance the potential toxicity of cyclosporine, include aminoglycoside antibiotics, amphotericin B, acyclovir, ketoconazole, lovastatin, NSAIDs, and ranitidine. Agents that are CYP3A3 and CYP3A4 inhibitors raise cyclosporine levels by decreasing biotransformation. These include methylprednisolone, amphotericin B, cimetidine, amiodarone, fluoxetine, protease inhibitors, erythromycin, and grapefruit juice. Agents that increase hepatic metabolism and, thus, lower cyclosporine levels include phenobarbital, phenytoin, carbamazepine, rifampin, trimethoprim, and St John's wort.

Because results vary depending on the method and cyclosporine antibody employed (monospecific or polyspecific), it is best for a given patient's specimens to be analyzed at a single laboratory to eliminate as many assay-dependent variables as possible.

Half-life of elimination; Oral: May be prolonged in patients with hepatitis impairment and may be shorter in pediatric patients due to the higher metabolism rate. The elimination profile of cyclosporine is biphasic. An early elimination phase with an apparent half-life that typically ranges from three to seven hours is followed by a slower elimination of phase with an apparent half-life ranging from 18 to 25 hours. The peak concentration is reached in four to six hours.

Specimen Requirements

Specimen

Whole blood

Volume

2 mL

Minimum Volume

0.6 mL

Container

Lavender-top (EDTA) tube or green-top (heparin) tube

Storage Instructions

Room temperature

Stability Requirements

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x3

Clinical Information

References

American Medical Association, Division of Drugs and Toxicology. Drug Evaluations Subscription. Chicago, Ill: AMA; Winter, 1993.
Burtis CA, Ashwood ER, Bruns DE. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 4th ed. St Louis, Mo: Elsevier Saunders; 2006:1274-1276.
Drug Information Handbook. 24th ed. Hudson, OH: Wolters Kluwer Clinical Drug Information, Inc; 2015; 522-529.
Hamwi A, Salomon A, Steinbrugger R, et al. Cyclosporine metabolism in patients after kidney, bone marrow, heart-lung, and liver transplantation in the early and late post-transplant periods. Am J Clin Pathol. 2000; 114(4):536-543. 11026099
Keevil BG, Tierney DP, Cooper DP, et al. Rapid liquid chromatography-tandem mass spectrometry method for routine analysis of cyclosporine A over an extended concentration range. Clin Chem. 2002; 48(1):69-76. 11751540
Oellerich M, Armstrong VW, Kahan B, et al. Lake Louise Consensus Conference on Cyclosporine Monitoring in Organ Transplantation: Report of the Consensus Panel. Ther Drug Monit. 1995; 17(6):642-654. 8588235
Physicians' Desk Reference. 66th ed. Montvale, NJ: Thompson PDR; 2012.
Yatscoff RW, Aspeslet LJ, Gallant HL. Pharmacodynamic monitoring of immunosuppressive drugs. Clin Chem. 1998; 44(2):428-432. 9474055

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
706556 Cyclosporine, Blood 55805-6 706559 Cyclosporine, LC-MS/MS ng/mL 55805-6
Reflex Table for Cyclosporine, LC-MS/MS
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 007000 See below: 007000 See below: N/A

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