Test Catalog

Test Id : CLOBZ

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Clobazam and Metabolite, Serum

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Overview

Test Catalog

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

Monitoring clobazam therapy

Highlights

Both clobazam and N-desmethylclobazam (norclobazam) are detected in serum specimens.

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

Clobazam and metabolite, S

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

Frisium

Norclobazam

Onfi

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

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Red top (serum gel/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. Collect blood immediately before next scheduled dose.

2. Within 2 hours of collection, centrifuge and aliquot serum into a plastic vial.

Additional Information: Trough specimens are recommended as therapeutic ranges are based on specimens collected at trough (ie, immediately before the next dose).

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. The minimum volume is sufficient for one attempt at testing.

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

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

Monitoring clobazam therapy

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

Clobazam is a broad spectrum, antiepileptic drug used for various types of seizures, Lennox-Gastaut syndrome (a type of childhood onset epilepsy), and migraine prophylaxis. Clobazam blocks voltage-dependent sodium channels, potentiates gamma-aminobutyric acid (GABA) activity at some of the GABA receptors, and inhibits potentiation of the glutamate receptor and carbonic anhydrase enzyme, all of which contribute to its antiepileptic and antimigraine efficacy.

 

In general, clobazam shows favorable pharmacokinetics with good absorption (1-4 hours for the immediate-release formulation), low protein binding, and minimal hepatic metabolism. Elimination is predominantly renal, and it is excreted unchanged in the urine with an elimination half-life of approximately 21 hours. As with other anticonvulsant drugs eliminated by the renal system, patients with impaired kidney function exhibit decreased clobazam clearance and a prolonged elimination half-life.

 

Serum concentrations of other anticonvulsant drugs are not significantly affected by the concurrent administration of clobazam, with the exception of patients on phenytoin whose serum concentrations can increase after the addition of clobazam. Other drug-drug interactions include the coadministration of phenobarbital, phenytoin, or carbamazepine, which can result in decreased clobazam concentrations. In addition, concurrent use of posaconazole and clobazam may result in the elevation of clobazam serum concentrations. Therefore, changes in cotherapy with these medications (phenytoin, carbamazepine, posaconazole, or phenobarbital) may require dose adjustment of clobazam, and therapeutic drug monitoring can be helpful. The most common adverse drug effects associated with clobazam include weight loss, loss of appetite, somnolence, dizziness, coordination problems, memory impairment, and paresthesia.

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.

Clobazam

Therapeutic Range: 30-300 ng/mL

 

N-desmethylclobazam (Norclobazam)

Therapeutic Range: 300-3,000 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

The results of this test should be interpreted in conjunction with the patient's physical signs, symptoms, and other laboratory test results.

 

Most individuals display optimal response to clobazam when serum levels of clobazam are between 30 and 300 ng/mL and N-desmethylclobazam are between 300 and 3000 ng/mL. Risk of toxicity is increased when clobazam levels are above 500 ng/mL or N-desmethlyclobazam levels are above 5000 ng/mL.

 

Some individuals may respond well outside of these ranges or may display toxicity within the therapeutic range; thus, interpretation should include clinical evaluation.

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. 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

2. Patsalos PN, Berry DJ, Bourgeois BF, et al: 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

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

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

Methodology involves a simple deproteinization using acetonitrile, followed by dilution, and analysis by liquid chromatography 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 through 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 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 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.

80339 (G0480 if appropriate)

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
CLOBZ Clobazam and metabolite, S 79408-1
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.
65483 Clobazam 3487-6
92363 N-desmethylclobazam 35107-2

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