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HelpTest ID RUFI Rufinamide, Serum
Useful For
Monitoring serum rufinamide concentrations, assessing compliance, and adjusting dosage in patients receiving other drugs that interact pharmacokinetically with rufinamide (ie, drugs that induce liver CYP3A4 enzymes) and may be helpful in those who are receiving hemodialysis
Method Name
Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)
Reporting Name
Rufinamide, SSpecimen Type
SerumSpecimen 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. Collect blood immediately before next scheduled dose.
2. For sustained-release formulations ONLY, collect 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
0.5 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 |
Clinical Information
Rufinamide is a new antiepileptic drug approved by the Food and Drug Administration as an add-on treatment for seizures associated with Lennox-Gastaut syndrome in children aged 4 years and older, and for the treatment of focal seizures in adults and adolescents. Its mechanism of action is not completely understood, but it is believed to work by prolonging the inactive state of sodium channels, therefore limiting excessive firing of sodium-dependent action potentials. The commonly observed side effects are headache, dizziness, fatigue, somnolence, and nausea.
Reference Values
5.0-30.0 mcg/mL
Interpretation
The reference interval is broad and represents the concentrations observed to be associated with the greatest drug efficacy without side effects or toxicity.
Cautions
No significant cautionary statements
Clinical Reference
1. Krasowski MD: Antiepileptic drugs. Therapeutic drug monitoring of the new generation drugs. Clinical Laboratory News. 2013 Jun;39(6):8-10
2. Aneja S, Sharma S. Newer anti-epileptic drugs. Indian Pediatr. 2013;50(11):1033-40. doi:10.1007/s13312-013-0284-9
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. doi:10.1055/s-0043-116492
Method Description
Deuterated internal standard in methanol is added to the standards, controls, and patient serum samples. The samples are then centrifuged, and the supernatant further diluted with mobile phase A and analyzed by ultrafast online solid-phase extraction tandem mass spectrometry.(Unpublished Mayo method)
Day(s) Performed
Tuesday, Thursday, Saturday
Report Available
3 to 5 daysTest 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
80210
NY State Approved
YesForms
If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.