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Test Code 5235 Sirolimus, Blood

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Whole Blood EDTA


Specimen Required


Container/Tube: Lavender top (EDTA)

Specimen Volume: 3 mL

Collection Instructions:

1. Draw blood immediately before a scheduled dose.

2. Do not centrifuge.

3. Send specimen in original tube.

Additional Information: Therapeutic range applies to trough specimen drawn immediately prior to a.m. dose.


Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time
Whole Blood EDTA Refrigerated (preferred) 28 days
  Ambient  28 days
  Frozen  28 days

Reference Values

4-20 ng/mL (Trough)

 

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

Day(s) and Time(s) Performed

Monday through Sunday; 1 p.m.

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

80195

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SIIRO Sirolimus, B 29247-4

 

Result ID Test Result Name Result LOINC Value
35144 Sirolimus, B 29247-4

Clinical Information

Sirolimus is a macrolide antibiotic, isolated from Streptomyces hygroscopicus, with potent effects including suppression of T- and B-cell proliferation and antineoplastic and antifungal activity. It inhibits the protein kinase mTOR to arrest the cell cycle; it has no effects on calcineurin and, therefore, can be used in addition to cyclosporine or tacrolimus, or as a substitute in patients intolerant to these drugs. Sirolimus is metabolized by CYP3A4, thus, blood concentrations are affected by drugs that inhibit or induce this enzyme. The pharmacokinetic interaction between sirolimus and cyclosporine or tacrolimus increases both therapeutic immunosuppression and the toxicity of these agents; lower doses are required with combined use. Adverse effects of sirolimus are generally concentration dependent, making therapeutic drug monitoring essential.

 

Trough sirolimus concentrations are generally measured every 5 days. Target concentrations vary depending on concomitant therapy, time posttransplant, the desired degree of immunosuppression, and adverse effects. When given with cyclosporine or tacrolimus, the therapeutic range for sirolimus is generally between 4 and 12 ng/mL with minimal added benefit for concentrations >10 ng/mL. When sirolimus is given without calcineurin inhibitors, higher trough levels are needed; usually 12 to 20 ng/mL, but occasionally up to 20 to 30 ng/mL.

Interpretation

Most individuals display optimal response to sirolimus with trough whole blood levels 4 to 20 ng/mL. Preferred therapeutic ranges may vary by transplant type, protocol, and comedications.

 

Therapeutic ranges are based on specimens drawn at trough (ie, immediately before a scheduled dose). Blood drawn at other times will yield higher results.

 

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

Clinical Reference

1. Kahan BD: Ten years of mTOR inhibitor therapy. Transplant Proc 2003;35(3A):3S-240S

2. Yakupoglu YK, Kahan BD: Sirolimus: a current perspective. Exp Clin Transplant 2003;1:8-18

3. Groth CG, Backman L, Morales JM, et al: Sirolimus (rapamycin)-based therapy in human renal transplantation: similar efficacy and different toxicity compared with cyclosporine. Sirolimus European Renal Transplant Study Group. Transplantation 1999 April;67(7):1036-1042

Method Name

High-Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS)