Leflunomide Metabolite (Teriflunomide), Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Therapeutic monitoring of patients actively taking leflunomide
Assessment of elimination in patients requiring enhanced elimination of the drug
High-Turbulence Liquid Chromatography Mass Spectrometry (HTLC-MS/MS)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Leflunomide Metabolite, S
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
1. Draw blood no sooner than 12 hours (trough value) after last dose.
2. Spin down within 2 hours of draw.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross reject
Mild OK; Gross reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum Red||Ambient (preferred)||14 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Leflunomide is a disease-modifying anti-rheumatic drug approved for therapy of rheumatoid arthritis and used off-label to reduce viral nephritis in renal transplant. It is a prodrug: rapid and complete metabolism converts leflunomide to its active metabolite, teriflunomide (also called A77 1726), which acts by inhibiting pyrimidine synthesis. Teriflunomide has a very long half-life, on average >2 weeks.
There is marked inter-individual variability in leflunomide pharmacokinetics, thus therapeutic monitoring of serum teriflunomide concentrations may be helpful in optimizing therapy. Therapeutic targets remain only loosely defined and appear to vary depending on the purpose of therapy, but serum teriflunomide concentrations >40 mcg/mL have been associated with better clinical outcomes. Due to the long half-life, serum specimens for therapeutic monitoring may be drawn at any point in the dosing cycle, although trough (immediately before next schedule dose) sampling is preferred for consistency. Adverse reactions to leflunomide do not correlate well with serum drug concentration, but include diarrhea, hypertension, and liver toxicity.
Enhanced elimination of the drug may be required in patients who are or who wish to become pregnant, or who are experiencing toxicity; teriflunomide can persist up to 2 years after ceasing therapy unless elimination is accelerated. This can be accomplished through use of activated charcoal or a bile acid sequestrant such as cholestyramine, reducing the half-life of teriflunomide to approximately 1 day. Serum concentrations <0.020 mcg/mL (<20 ng/mL) on 2 independent tests at least 2 weeks apart, are preferred for patients anticipating pregnancy to minimize the potential risk of teratogenesis associated with the drug.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Therapeutic: >40 mcg/mL
Elimination: <0.020 mcg/mL
Therapy: clinical targets for serum teriflunomide (leflunomide metabolite) concentrations are still being determined, but levels >40 mcg/mL appear to correlate with better outcome.
Elimination: serum concentrations <0.020 mcg/mL (20 ng/mL) are preferred to minimize potential teratogenesis for patients considering pregnancy.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Leflunomide toxicity does not appear to correlate with teriflunomide concentrations, thus this assay is unlikely to aid in evaluation of potential adverse drug reactions.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Cannon GW, Kremer JM: Leflunomide. Rheum Dis Clin North Am 2004;30(2):295-309
2. Chan V, Charles BG, Tett SE: Population pharmacokinetics and association between A77 1726 plasma concentrations and disease activity measures following administration of leflunomide to people with rheumatoid arthritis. Br J Clin Pharmacol 2005;60(3):257-64
3. Teschner S, Gerke P, Geyer, et al: Leflunomide therapy for polyomavirus-induced allograft nephropathy: efficient BK virus elimination without increased risk of rejection. Transplant Proc 2009;41(6):2533-8
4. Temprano KK, Bandlamudi R, Moore TL: Antirheumatic drugs in pregnancy and lactation. Semin Arthritis Rheum 2005;35(2):112-121
Method Description Describes how the test is performed and provides a method-specific reference
Serum samples are diluted in an aqueous solution containing deuterated teriflunomide as an internal standard. This is injected onto a liquid chromatography system with Cohesive turboflow to separate the drug from serum components, and analyzed by negative-ion mode tandem mass spectrometry. (Unpublished Mayo method)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Wednesday, Sunday; 11 am
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|60292||Leflunomide Metabolite, S||In Process|