Everolimus by Tandem Mass Spectrometry
0092118
Ordering Recommendation
•Therapeutic monitoring for individuals taking everolimus.
Mnemonic
EVEROLIMUS
Methodology
Quantitative Liquid Chromatography-Tandem Mass Spectrometry
Performed
Sun-Sat
Reported
Within 24 hours  
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
Pre-dose (trough) levels should be drawn.  
Collect
Lavender (EDTA) or pink (K2EDTA).  
Specimen Preparation
Transport 1 mL whole blood. (Min: 0.25 mL)  
Storage/Transport Temperature
Refrigerated.  
Unacceptable Conditions
Serum or plasma. Specimens left at room temperature for longer than 24 hours. Clotted specimens.  
Remarks
  
Stability
Ambient: 24 hours; Refrigerated: 2 weeks; Frozen: 2 weeks  
Reference Interval
Effective February 18, 2014
 
 Therapeutic Range:
Kidney transplant (in combination with Cyclosporine): 3-​8 ng/mL
Liver transplant (in combination with Tacrolimus): 3-​8 ng/mL
Toxic value: Greater than 15 ng/mL
Interpretive Data
Everolimus marketed as Zortress is FDA approved for prophylaxis of organ rejection in adult patients receiving a kidney and liver transplant.

Everolimus marketed as Afinitor is FDA approved for the treatment of renal cell carcinoma and for the treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) in patients who are not candidates for curative surgical resection. The suggested therapeutic range for treatment of SEGA is 5-15 ng/mL, which is based on a predose (trough) specimen.

The optimal therapeutic range for a given patient may differ from this suggested range based on the indication for therapy, treatment phase (initiation or maintenance), use in combination with other drugs, time of specimen collection relative to prior dose, type of transplanted organ, and/or the therapeutic approach of the transplant center.

See Compliance Statement B: www.aruplab.com/CS
Statement B: This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
 
Note
Everolimus (Zortress, Certican, Afinitor) whole blood concentrations can be measured by either chromatographic or immunoassay methodologies.  These two methodologies are not directly interchangeable, and the measured everolimus whole blood concentration depends on the methodology used, and reference ranges may vary according to specific immunoassay or HPLC/MS/MS test. Generally, immunoassays have been reported to have a positive test bias relative to HPLC-MS/MS assays, due to the detection of antibody cross-reactivity with everolimus metabolites.
CPT Code(s)
80169
Components
Component Test Code*Component Chart Name
0092118Everolimus by HPLC-MS/MS
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • Afinitor
  • Certican
  • Everolimus, Blood
  • Zortress