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Test ID PERAM Perampanel, Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Red top (serum gel/SST is not acceptable)

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 a plastic vial within 2 hours of collection.


Useful For

Monitoring serum concentration of perampanel, in specific clinical conditions (ie, severe kidney impairment, mild to moderate hepatic impairment, and end-stage kidney disease)

 

Assessing compliance

 

Assessing potential toxicity

Method Name

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

Reporting Name

Perampanel, S

Specimen Type

Serum Red

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
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

Perampanel (Fycompa) is approved for adjunctive therapy to treat primary generalized tonic-clonic seizures in patients aged 12 years and older as well as the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 4 years and older.

Reference Values

180-980 ng/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 perampanel is coadministered with other anticonvulsant drugs.

 

Most individuals display optimal response to perampanel with serum levels 180 to 980 ng/mL. Some individuals may respond well outside of this range or may display toxicity within the therapeutic range; thus, interpretation should include clinical evaluation. Toxic levels have not been well established. Therapeutic ranges are based on specimen collected at trough (ie, immediately before the next dose).

Cautions

This test cannot be performed on whole blood.

Clinical Reference

1. Reimers A, Berg JA, Burns ML, Brodtkorb E, Johannessen SI, Johannessen Landmark C. Reference ranges for antiepileptic drugs revisited: a practical approach to establish national guidelines. Drug Des Devel Ther. 2018;12:271-280. doi:10.2147/DDDT.S154388

2. 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

3. Milone MC, Shaw LM. Therapeutic drugs and their management. In: Rifai N, Chiu RWK, Young I, Burnham CAD, Wittwer CT, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:420-453

Method Description

The serum sample is diluted in acetonitrile internal standard. The protein precipitate is centrifuged, and a portion of the supernatant is diluted with mobile phase for detection by a tandem mass spectrometer.(Unpublished Mayo method)

Day(s) Performed

Tuesday, Friday

Report Available

2 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.

CPT Code Information

80299

NY State Approved

Yes

Forms

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