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Test Code SOFT: Z1000 Lacosamide, Serum

Additional Codes

Ordering Mnemonic Mayo Test ID
EPIC NAME: MISC. LAB TEST LACO
EPIC CODE: LAB000  

 

Reporting Name

Lacosamide, S

Useful For

Monitoring serum concentrations of lacosamide to ensure compliance and appropriate dosing in specific clinical conditions (ie, severe kidney impairment, mild-to-moderate hepatic impairment, and kidney failure)

Method Name

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

Portions of this test are covered by patents held by Quest Diagnostics

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Specimen Required


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. Collect specimen immediately before next scheduled dose.

2. For sustained-release formulations ONLY, collect specimen a minimum of 12 hours after last dose.

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


Specimen Minimum Volume

0.2 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

Patients receiving therapeutic doses usually have lacosamide concentrations of 1.0 to 10.0 mcg/mL.

Day(s) Performed

Monday through Saturday

CPT Code Information

80235

LOINC Code Information

Test ID Test Order Name Order LOINC Value
LACO Lacosamide, S 59297-2

 

Result ID Test Result Name Result LOINC Value
62772 Lacosamide, S 59297-2

Clinical Information

Lacosamide is approved for adjunctive therapy to treat partial-onset seizures in epileptic patients aged 17 years and older. In clinical trials, the most common side effects were dizziness, headache, nausea, and double vision. Lacosamide is completely absorbed after oral administration with negligible first-pass metabolism. Peak serum concentrations occur 1 to 4 hours after oral dosing, and the elimination half-life is approximately 13 hours. Steady-state serum concentrations are achieved after 3 days of twice daily repeated administration. About 40% of the administered dose is eliminated by the renal system unchanged, and 30% is metabolized by hepatic isoenzymes (CYP2C9, CYP2C19, and CYP3A4) to the O-desmethyl inactive metabolite. The relationship between lacosamide serum concentrations and its efficacy or adverse effects is not well established. However, central nervous system toxicity has been associated with higher drug concentrations in serum.

Interpretation

The serum concentration should be interpreted in the context of the patient's clinical response and may provide useful information in patients showing poor response or adverse effects, particularly when lacosamide is co-administered with other anticonvulsant drugs.

 

Toxic ranges are not well established but occur more frequently when concentrations are greater or equal to 20 mcg/mL.

Cautions

Abnormalities in liver function tests (eg, alanine aminotransferase) have been observed in controlled trials in adult patients with partial-onset seizures who were taking 1 to 3 concomitant antiepileptic drugs.

Clinical Reference

1. VIMPAT Medication Guide. Harris FRC Corporation. UCB, Inc; Revised 09/2022. Accessed April 23, 2024. Available at www.ucb-usa.com/vimpat-prescribing-information.pdf

2. Patsalos PN, Berry DJ. Pharmacotherapy of the third-generation AEDs: lacosamide, retigabine and eslicarbazepine acetate. Expert Opin Pharmacother. 2012;13(5):699-715

3. Chung SS. New treatment option for partial-onset seizures: efficacy and safety of lacosamide. Ther Adv Neurol Disord. 2010;3(2):77-83

4. Sattler A, Schaefer M, May TW, Rambeck B, Brandt C. Fluctuation of lacosamide serum concentrations during the day and occurrence of adverse drug reactions-first clinical experience. Epilepsy Res. 2011;95(3):207-212

5. Greenaway C, Ratnaraj N, Sander JW, Patsalos PN. Saliva and serum lacosamide concentrations in patients with epilepsy. Epilepsia. 2011;52(2):258-263

6. McMullin M, Dalrymple R. Analysis for lacosamide in human serum by LC/MS/MS and a summary of 8,000 patient values. Ther Drug Monit. 2011;33(4):520-521

7. 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. doi:10.1055/s-0043-116492

Method Description

Lacosamide and the internal standard are separated from other serum constituents by high-performance liquid chromatography with analysis on a tandem mass spectrometer equipped with an electrospray ion source using multiple reaction monitoring.(Unpublished Mayo method)

Report Available

Same day/1 to 4 days

Specimen Retention Time

14 days

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.

Forms

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

-Neurology Specialty Testing Client Test Request (T732)

-Therapeutics Test Request (T831)

Secondary ID

62905