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Test ID ITCON Itraconazole, Serum


Specimen Required


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

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial.


Forms

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

Secondary ID

81247

Useful For

Verifying systemic absorption of orally administered itraconazole

 

Patients with life-threatening fungal infections

 

Patients considered at risk for poor absorption or rapid clearance of itraconazole

Method Name

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

Reporting Name

Itraconazole, S

Specimen Type

Serum Red

Specimen Minimum Volume

0.18 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Red Refrigerated (preferred) 29 days
  Ambient  29 days
  Frozen  29 days

Clinical Information

Itraconazole is a synthetic triazole antifungal drug approved for treatment and prophylaxis of a variety of fungal infections. Its activity results from inhibition of fungal synthesis of ergosterol, an integral component of fungal cell membranes.

 

Concerns about adequate absorption and drug interactions are some of the major indications for therapeutic drug monitoring. Mean oral bioavailability approximates 55% but is highly variable; absorption can be enhanced by food or acidic drinks. Hepatic enzyme inducers can cause low serum itraconazole levels, and coadministration of these drugs has been associated with itraconazole therapeutic failure.

 

Itraconazole therapeutic efficacy is greatest when serum concentrations exceed 0.5 mcg/mL for localized infections or 1.0 mcg/mL for systemic infections. An active metabolite, hydroxyitraconazole, is present in serum at roughly twice the level of the parent drug. These concentrations refer to analysis by high-performance liquid chromatography; quantitation by bioassay generates considerably higher apparent drug measurements due to reactivity with the active metabolite.

Reference Values

ITRACONAZOLE (TROUGH):

>0.5 mcg/mL (localized infection)

>1 mcg/mL (systemic infection)

 

HYDROXYITRACONAZOLE:

No therapeutic range established; activity and serum concentration are similar to parent drug.

Cautions

Enteropathy, H2-histamine receptor blockers, hepatic enzyme inducers, and other variables can result in low to non-detectable serum levels with concomitant high risk of therapeutic failure.

 

Patients with AIDS and organ transplant recipients receiving immunosuppressive therapy tend to have lower serum itraconazole levels on standard doses and are thus at high risk of therapeutic failure.

Day(s) Performed

Monday through Friday 7a.m., Saturday 3 p.m.

Report Available

1 to 3 days

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

80189

NY State Approved

Yes