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HelpTest Code LAB3112 Cenobamate, Serum
Specimen Required
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: 1.2 mL Serum
Collection Instructions: Within 2 hours of collection, centrifuge, and aliquot serum into a plastic vial.
Secondary ID
624174Useful For
Monitoring serum concentrations of cenobamate to optimize efficacy and minimize toxicity
Method Name
Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)
Reporting Name
Cenobamate, SSpecimen Type
Serum RedSpecimen Minimum Volume
Serum: 0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum Red | Refrigerated (preferred) | 28 days |
| Ambient | 28 days | |
| Frozen | 28 days |
Reject Due To
| Gross hemolysis | OK |
| Gross lipemia | OK |
| Gross icterus | OK |
Clinical Information
Cenobamate was approved by the US Food and Drug Administration for the treatment of partial-onset seizures in adult patients. Cenobamate reduces repetitive neuronal firing by inhibiting voltage-gated sodium currents and is a positive allosteric modulator of the gamma-aminobutyric acid (GABA-A) ion channel.
Common side effects may include double vision (diplopia), dizziness, somnolence, fatigue, or headache. Severe effects include QT interval shortening and acute hepatic failure.
Cenobamate has good oral bioavailability (88%) is extensively metabolized and primarily eliminated through the renal system (approximately 6% unchanged) with a long elimination half-life (50-60 hours).
Reference Values
Trough concentrations of 5 to 35 mcg/mL for daily dosages of 100 to 400 mg/day
Interpretation
Ninety-five percent of patients with 50% seizure reduction or seizure freedom had trough serum cenobamate concentrations between 5 mcg/mL and 35 mcg/mL when taking 100 to 400 mg/day.
Cautions
No significant cautionary statements
Clinical Reference
1. Greene SA, Kamin M. Cenobamate Trough Plasma Concentrations in Patients With Uncontrolled Focal Seizures Achieving 50% and 100% Seizure Reduction in Two Randomized Clinical Studies (1377). Neurology 2021;96(15_supplement):1377
2. Krauss GL, Klein P, Brandt C, et al. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol. 2020;19(1):38-48. doi:10.1016/S1474-4422(19)30399-0
3. Roberti R, De Caro C, Iannone LF, Zaccara G, Lattanzi S, Russo E. Pharmacology of Cenobamate: Mechanism of Action, Pharmacokinetics, Drug-Drug Interactions and Tolerability. CNS Drugs. 2021;35(6):609-618. doi:10.1007/s40263-021-00819-8
4. Wheless JW. Adjunctive cenobamate for the treatment of focal onset seizures in adults with epilepsy: a critical review. Expert Rev Neurother. 2020;20(11):1085-1098. doi:10.1080/14737175.2020.1834855
5. Steinhoff BJ, Georgiou D, Dietmann D, Intravooth T. Cenobamate plasma levels in patients with epilepsy: correlation with efficacy and tolerability?. J Clin Med. 2024;13(10):2757. doi:10.3390/jcm13102757
6. Johannessen Landmark C, Belkilani H, Awad L, et al. Pharmacokinetic variability and complex two-way interactions with cenobamate in patients with refractory epilepsy. Epilepsia. 2026;67(6):2820-2835. doi:10.1002/epi.70184
7. Elliott T, Ridley-Pryor T, Gienapp AJ, Wheless JW. Initial real-world experience with cenobamate in adolescents and adults: A single center experience. Pediatr Neurol. 2022;129:19-23. doi:10.1016/j.pediatrneurol.2022.01.001
8. Beltran-Corbellini A, Romeral-Jimenez M, Mayo P, et al. Cenobamate in patients with highly refractory focal epilepsy: A retrospective real-world study. Seizure. 2023;111:71-77. doi:10.1016/j.seizure.2023.07.026
9. Smith MC, Klein P, Krauss GL, et al. Dose Adjustment of Concomitant Antiseizure Medications During Cenobamate Treatment: Expert Opinion Consensus Recommendations. Neurol Ther. 2022;11(4):1705-1720. doi:10.1007/s40120-022-00400-5
Method Description
The sample is diluted with an acetonitrile internal standard. The protein precipitate is centrifuged, and a portion of the supernatant is diluted for detection by a tandem mass spectrometry.(Unpublished Mayo method)
Day(s) Performed
Monday through Friday
Report Available
Same day/1 to 2 daysSpecimen Retention Time
2 weeksPerforming 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. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
80299
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| CENO | Cenobamate, S | 96909-7 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 624174 | Cenobamate, S | 96909-7 |