Test Catalog

Test Id : FELBA

Felbamate (Felbatol), Serum

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

Determining whether a poor therapeutic response is attributable to noncompliance or lack of drug effectiveness

 

Monitoring changes in serum concentrations resulting from interactions with coadministered drugs such as barbiturates and phenytoin

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

Liquid Chromatography Tandem Mass Spectrometry (LC-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

Felbamate (Felbatol), S

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

Felbamate (Felbatol)

Felbatol (Felbamate)

FELBA

Specimen Type
Describes the specimen type validated for testing

Serum

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

Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Draw blood immediately before next scheduled dose.

2. Within 2 hours of collection, centrifuge the specimen.

3. For red-top tubes, immediately aliquot serum into a plastic vial.

4. For serum-gel tubes, aliquot serum into a plastic vial within 24 hours of collection.

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Neurology Specialty Testing Client Test Request (T732)

-Therapeutics Test Request (T831)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.5 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 Refrigerated (preferred) 28 days
Ambient 28 days
Frozen 28 days

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

Determining whether a poor therapeutic response is attributable to noncompliance or lack of drug effectiveness

 

Monitoring changes in serum concentrations resulting from interactions with coadministered drugs such as barbiturates and phenytoin

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

Felbamate is an anticonvulsant drug approved for treatment of partial seizures with or without secondary generalization in persons 14 years and older. It is also approved for Lennox-Gastout syndrome in children 2 years and older. Felbamate is well absorbed (>90%) and is metabolized by the hepatic cytochrome P450 system. Metabolites lack anticonvulsant activity. The elimination half-life of felbamate ranges from 16 to 22 hours.

 

Optimal response to felbamate is seen with serum concentrations between 30 mcg/mL to 80 mcg/mL. Patients who are older adults or have kidney dysfunction may require reduced dosing; felbamate should not be given to individuals with hepatic disease. Toxicity can be severe, including life-threatening aplastic anemia or liver failure; toxic concentration has been established at concentrations greater than 100 mcg/mL.

 

Coadministration of felbamate increases the concentration of phenytoin and valproic acid, decreases carbamazepine concentration, and increases carbamazepine-10,11-epoxide (its active metabolite). Conversely, coadministration of phenytoin or carbamazepine causes a decrease in felbamate concentration.

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.

30.0-80.0 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

Optimal response to felbamate is associated with serum concentrations of 30 mcg/mL to 80 mcg/mL.

 

Toxic serum concentrations for felbamate have been established at concentrations greater than 100 mcg/mL.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

No significant cautionary statements

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Johannessen SI, Tomson T. Pharmacokinetic variability of newer antiepileptic drugs: when is monitoring needed? Clin Pharmacokinet. 2006;45(11):1061-1075

2. Schmidt D. Felbamate: successful development of a new compound for the treatment of epilepsy. Epilepsia. 1996;34(Suppl 7):S30-S33

3. Patsalos PN: Antiepileptic drugs-best practice guidelines for therapeutic drug monitoring: a position paper by the subcommission on therapeutic drug monitoring, ILAE Commission on Therapeutic Strategies. Epilepsia. 2008;49(7):1239-1276

4. Rifai N, Horwath AR, Wittwer CT, eds: Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018

5. Hiemke C, Bergemann N, Clement HW, et al. Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: Update 2017. Pharmacopsychiatry. 2018;51(1-02):9-62

Method Description
Describes how the test is performed and provides a method-specific reference

Samples are diluted and extracted online by high turbulence liquid chromatography with detection by 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.

Same day/1 to 3 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 account representative. 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. It 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.

80167

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
FELBA Felbamate (Felbatol), S 6899-9
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.
80782 Felbamate (Felbatol), S 6899-9

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