#ExistInterpData>Everolimus marketed as Zortress® is FDA approved for prophylaxis of organ rejection in adult patients receiving a kidney transplant. The suggested therapeutic range for pre-transplant prophylaxis is 3-8 ng/mL, which is based on a predose (trough) specimen in patients also receiving cyclosporine.
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 5-10 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. Symptoms of toxicity are more likely at predose (trough) concentrations that exceed 15 ng/mL.
See Compliance Statement B: www.aruplab.com/CS
||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 upon the type of assay used. Reference ranges may vary according to specific immunoassay or LC/MS/MS test used. Generally, immunoassays have been reported to have a positive test bias relative to the reference assay, HPLC with detection by tandem mass spectrometry (LC/MS/MS).
||Afinitor (Everolimus by Tandem Mass Spectrometry), Certican (Everolimus by Tandem Mass Spectrometry), Everolimus, Blood (Everolimus by Tandem Mass Spectrometry), Zortress (Everolimus by Tandem Mass Spectrometry)