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Epic Code LAB1230051 Rufinamide, Serum

Important Note

1. Draw blood immediately before next scheduled dose.

Additional Codes

Mayo Code: RUFI

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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

Specimen Type

Serum


Specimen Required


Collection 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.


Laboratory Test Directory Note:

COLLECTION NOTE: Volumes listed are in serum or plasma, draw approximately 2 1/2 times the requested volume in whole blood.

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

Day(s) Performed

Tuesday, Thursday, Saturday

Reference Values

5.0-30.0 mcg/mL

Clinical Information

Rufinamide is a new antiepileptic drug approved by the Food and Drug Administration as add-on treatment for seizures associated with Lennox-Gastaut syndrome in children 4 years of age or 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.

Cautions

No significant cautionary statements

Interpretation

The reference interval is broad and represents the concentrations observed to be associated with the greatest drug efficacy without side effects or toxicity.

Reporting Name

Rufinamide, S

Method Name

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

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)

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

Report Available

3 to 5 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.

Clinical Reference

1. Krazowski 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 Nov 8;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 Jan;51(1-02):9-62. doi: 10.1055/s-0043-116492

Forms

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