The therapeutic range is based on serum pre-dose (trough) draw at steady-state concentration. A proposed therapeutic range is 1.0-3.5 µg/mL for a 2 g/day dose. A 3 g/day dose may have plasma concentrations up to 5.0 µg/mL. Trough concentrations between 2.0 and 4.0 µg/mL have been suggested to maximize efficacy and minimize adverse effects. Mycophenolic acid glucuronide is an inactive metabolite and a range of 35.0-100.0 µg/mL indicates normal metabolism. During the first two weeks of transplantation, mycophenolic acid glucuronide concentrations are typically 100 - 250 µg/mL. Adverse effects of toxicity include abdominal pain, peripheral edema, cardiac abnormalities, hypertension and electrolyte disturbances.
Statement B: Compliance Statement B
: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations.
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.