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Test Code SOFT: Z0670 Levetiracetam, Serum

Additional Codes

Ordering Mnemonic Mayo Test ID
EPIC NAME: LEVETIRACETAM, SERUM LEVE
EPIC CODE: LAB971  

 

Reporting Name

Levetiracetam, S

Useful For

Monitoring serum concentration of levetiracetam, particularly in patients with kidney disease

 

Assessing compliance with levetiracetam therapy

 

Assessing potential toxicity of levetiracetam

Method Name

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Collection 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. For sustained-release formulations only, draw blood a minimum of 12 hours after last dose.

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


Specimen Minimum Volume

0.5 mL

Specimen Stability Information

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

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Reference Values

10.0-40.0 mcg/mL

Day(s) Performed

Monday through Sunday

CPT Code Information

80177

LOINC Code Information

Test ID Test Order Name Order LOINC Value
LEVE Levetiracetam, S 30471-7

 

Result ID Test Result Name Result LOINC Value
83140 Levetiracetam, S 30471-7

Test Classification

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.

Clinical Information

Levetiracetam is approved for treatment of partial, myoclonic, and tonic-clonic seizures and is used off-label for manic states and migraine prophylaxis. Levetiracetam has very favorable pharmacokinetics with good bioavailability and rapid achievement of steady state. Its hepatic metabolism is minimal and nonoxidative, making it safe for use with hepatic enzyme inducers or inhibitors. The major metabolite is a carboxylic acid derivate, which is inactive and accounts for roughly one quarter of the administered dose. Levetiracetam is excreted renally, with a mean half-life of 7 hours in adults and slightly less than that in children. Kidney dysfunction may warrant therapeutic monitoring and/or dose adjustment.

 

Given the lack of drug interactions and favorable pharmacokinetics, the primary uses for therapeutic drug monitoring of levetiracetam are compliance assurance and management of physiological changes such as puberty, pregnancy, and aging. Toxicities associated with levetiracetam use include decreased hematocrit and red blood cell count, decreased neutrophil count, somnolence, asthenia, and dizziness. These toxicities may be associated with blood concentrations in the therapeutic range.

Interpretation

Most individuals display optimal response to levetiracetam with serum levels 10.0 to 40.0 mcg/mL. Some individuals may respond well outside of this range or may display toxicity within the therapeutic range; thus, interpretation should include clinical evaluation.

 

Toxic levels have not been well established. Therapeutic ranges are based on specimen collected at trough (ie, immediately before the next dose).

Cautions

This test cannot be performed on whole blood.

Clinical Reference

1. 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

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

3. 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

The serum sample is diluted in acetonitrile containing internal standard. The protein precipitate is centrifuged, and a portion of the supernatant is diluted with mobile phase for detection by a tandem mass spectrometer.(Unpublished Mayo method)

Report Available

Same day/1 to 2 days

Specimen Retention Time

14 days

Forms

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

-Neurology Specialty Testing Client Test Request (T732)

-General Request (T239)

-Therapeutics Test Request (T831)

Secondary ID

83140