Ordering Recommendation

Optimize drug therapy and monitor patient adherence.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation

Timing of specimen collection: Pre-dose (trough) draw - At steady state concentration.

Collect

Plain red. Also acceptable: Lavender (K2 or K3EDTA) or pink (K2EDTA).

Specimen Preparation

Separate serum or plasma from cells within 2 hours of collection. Transfer 1 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.1 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Whole blood. Gel separator tubes, light blue (citrate), or yellow (SPS or ACD solution).

Remarks
Stability

After separation from cells: Ambient: 6 weeks; Refrigerated: 6 weeks; Frozen: 11 months

Methodology

Quantitative Liquid Chromatography-Tandem Mass Spectrometry

Performed

Sun-Sat

Reported

1-4 days

Reference Interval

Available Separately
Component
Therapeutic Range
Toxic
No Mycophenolic Acid 1.0 - 3.5 µg/mL Greater than 25.0 µg/mL
No Mycophenolic Acid Glucuronide 35.0-100.0 µg/mL Not well established

Interpretive Data

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. 

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

Note

Hotline History

N/A

CPT Codes

80180

Components

Component Test Code* Component Chart Name LOINC
0090213 Mycophenolic Acid by HPLC-MS/MS 55806-4
2010110 Mycophenolic Acid Glucuronide 55807-2
* 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

  • Cellcept
  • CellCept MPA
  • Myfortic
Mycophenolic Acid and Metabolites