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23465 Itraconazole (ITCON)

Itraconazole (ITCON)
Test Code: ITCONSO
Synonyms/Keywords
​Ref Lab Code: Itraconazole, Antimicrobial Assay, Sporanox (Itraconazole)
Useful For
Verifying systemic absorption of orally administered itraconazole.
 
The test is indicated in patients with life-threatening fungal infections and in patients considered at risk for poor absorption or rapid clearance of itraconazole.​
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
Serum​ ​Red Top Tube ​1 mL ​0.18 mL
Collection Processing Instructions
​Send specimen in plastic vial
Specimen Stability Information
Specimen Type Temperature Time
​Serum ​Refrigerated (preferred) ​29 days
​Ambient ​29 days
​Frozen ​29 days
Rejection Criteria
Serum gel tube​ ​
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Clinic Laboratories Monday through Friday​ ​Same day/1 day
Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)​
Reference Lab
Test 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 HPLC; quantitation by bioassay results in considerably higher apparent drug measurements, due to reactivity with the active metabolite.
Reference Range Information
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.
Interpretation

A lower cutoff concentration has not been defined that applies in all cases. The serum concentration must be interpreted in association with other variables, such as the nature of the infection, the specific microorganism, and minimal inhibitory concentration (MIC) results, if available. Localized infections are more likely to respond when serum itraconazole is more than 0.5 mcg/mL (by high-performance liquid chromatography); systemic infections generally require drug concentrations more than 1.0 mcg/mL. Consider target of more than 1.5 mcg/mL for itraconazole plus hydroxyitraconazole.

Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
80189
Synonyms/Keywords
​Ref Lab Code: Itraconazole, Antimicrobial Assay, Sporanox (Itraconazole)
Ordering Applications
Ordering Application Description
​Centricity ​Itraconazole, Sera, Plasma, CSF (81247)
​Cerner ​Itraconazole (81247)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
Serum​ ​Red Top Tube ​1 mL ​0.18 mL
Collection Processing
​Send specimen in plastic vial
Specimen Stability Information
Specimen Type Temperature Time
​Serum ​Refrigerated (preferred) ​29 days
​Ambient ​29 days
​Frozen ​29 days
Rejection Criteria
Serum gel tube​ ​
Useful For
Verifying systemic absorption of orally administered itraconazole.
 
The test is indicated in patients with life-threatening fungal infections and in patients considered at risk for poor absorption or rapid clearance of itraconazole.​
Reference Range Information
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.
Interpretation

A lower cutoff concentration has not been defined that applies in all cases. The serum concentration must be interpreted in association with other variables, such as the nature of the infection, the specific microorganism, and minimal inhibitory concentration (MIC) results, if available. Localized infections are more likely to respond when serum itraconazole is more than 0.5 mcg/mL (by high-performance liquid chromatography); systemic infections generally require drug concentrations more than 1.0 mcg/mL. Consider target of more than 1.5 mcg/mL for itraconazole plus hydroxyitraconazole.

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Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Clinic Laboratories Monday through Friday​ ​Same day/1 day
Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)​
Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
80189
For most current information refer to the Marshfield Laboratory online reference manual.