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Test Code LACO Lacosamide, Serum

Useful For

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

Reporting Name

Lacosamide, S

Specimen Type

Serum


Specimen Required


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. 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

Clinical Information

Lacosamide is approved for adjunctive therapy to treat partial-onset seizures in epileptic patients 17 years of age 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 plasma concentrations occur 1 to 4 hours after oral dosing, and the elimination half-life is approximately 13 hours. Steady-state plasma 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 plasma concentrations and its efficacy or adverse effects is not well established. However, central nervous system toxicity has been associated with higher drug concentrations in plasma.

Reference Values

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

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.

Clinical Reference

1. VIMPAT Medication Guide. Harris FRC Corporation. UCB, Inc; Revised 06/2019. Accessed June 24,2020. Available at www.vimpat.com/vimpat-medication-guide.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;3:77-83

4. Sattler A, Schaefer M, May TW, et al: 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;52:258-263

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;51:9-62

Day(s) and Time(s) Performed

Monday through Friday; 9 a.m.

Saturday; 1 p.m.

Analytic Time

Same day/1 day

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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 U.S. Food and Drug Administration.

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

Method Name

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

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

Forms

If not ordering electronically, complete, print, and send a Neurology Specialty Testing Client Test Request (T732) with the specimen.