Test Catalog

Test Id : LEFLU

Leflunomide Metabolite (Teriflunomide), Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Therapeutic monitoring of patients actively taking leflunomide

 

Assessment of elimination in patients requiring enhanced elimination of the drug

Method Name
A short description of the method used to perform the test

High-Turbulence Liquid Chromatography Mass Spectrometry (HTLC-MS/MS)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Leflunomide Metabolite, S

Aliases
Lists additional common names for a test, as an aid in searching

A77 1726

Arava

Leflunomide

Leflunomide metabolite

Teriflunomide

Specimen Type
Describes the specimen type validated for testing

Serum Red

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Draw blood no sooner than 12 hours (trough value) after last dose.

2. Centrifuge within 2 hours of collection and aliquot serum into plastic vial.

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.3 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Red Ambient (preferred) 28 days
Frozen 28 days
Refrigerated 28 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Therapeutic monitoring of patients actively taking leflunomide

 

Assessment of elimination in patients requiring enhanced elimination of the drug

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Leflunomide is a disease-modifying antirheumatic 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, greater than 2 weeks on average.

 

There is marked interindividual 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 greater than 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 less than 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

Interpretation
Provides information to assist in interpretation of the test results

Therapy: clinical targets for serum teriflunomide (leflunomide metabolite) concentrations are still being determined, but levels greater than 40 mcg/mL appear to correlate with better outcome.

 

Elimination: serum concentrations less than 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
Recommendations for 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):257-264

3. Teschner S, Gerke P, Geyer M, et al: Leflunomide therapy for polyomavirus-induced allograft nephropathy: efficient BK virus elimination without increased risk of rejection. Transplant Proc. 2009;41(6):2533-2538

4. Temprano KK, Bandlamudi R, Moore TL: Antirheumatic drugs in pregnancy and lactation. Semin Arthritis Rheum. 2005;35(2):112-121

5. Hirsch HH, Randhawa PS, AST Infectious Diseases Community of Practice: BK polyomavirus in solid organ transplantation-Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019 Sep;33(9):e13528. doi: 10.1111/ctr.13528

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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday, Wednesday, Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

3 to 5 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) 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 US 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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80193

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
LEFLU Leflunomide Metabolite, S 44828-2
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
60292 Leflunomide Metabolite, S 44828-2

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports