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Test Code 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, S

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. 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.

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further diluted with mobile phase A and analyzed by ultrafast online solid-phase extraction tandem mass spectrometry.(Unpublished Mayo method)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

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. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

80210

LOINC Code Information

Test ID Test Order Name Order LOINC Value
RUFI Rufinamide, S 59323-6

 

Result ID Test Result Name Result LOINC Value
63030 Rufinamide, S 59323-6

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

Secondary ID

63030