Available Stat

No

Performing Lab

China Basin Chemistry

Performed

Monday, Wednesday and Friday (excluding holidays)

In order to be run on Monday, Wednesday or Friday, samples have to be received by the lab by 5am that day.

Methodology

LC-MS/MS

Reported

2-3 days.

Additional Information

Background
Posaconazole is a triazole antifungal agent with potent activity against yeasts and molds. It is proven to be effective in the prophylaxis of invasive fungal infections in immunocompromised patients, and is considered an alternative treatment for zygomyces, invasive Aspergillus infections, Candida and other infections caused by pathogenic yeasts.
Posaconazole was originally available only as an oral suspension with limited bioavailability.  A delayed-release tablet formulation with improved absorption and an intravenous formulation are now available.  The oral suspension and delayed-release tablet are not directly interchangeable – consultation with ID pharmacy is strongly recommended if switching between formulations. Posaconazole is an inhibitor of cytochrome P450 3A4 and a substrate of the p-glycoprotein drug transporter.

Indications for Posaconazole TDM

1) Any use of the oral suspension for prolonged (>7 days) use for prophylaxis or treatment.

2) Use of the delayed-release tablet formulation in patients receiving the drug for prophylaxis and with one or more of the following:
- known or suspected gastrointestinal absorption abnormalities
- altered pharmacokinetics
-receipt of other drugs likely to have a significant interaction with posaconazole (e.g. phenytoin, rifabutin, carbamezapine) which cannot be discontinued without an adverse effect on patient care
- experiencing substantial hepatic toxicity (AST/ALT > 5 times upper limit of normal or total bilirubin > 3 mg/dl) while on posaconazole, with other potential causes ruled out.
- If develops concern for breakthrough infection while on prophylaxis

3) Use of the delayed-release tablet formulation or the intravenous formulation when used to treat invasive fungal infections 

When trough levels are indicated, samples should be obtained 5-7 days after: 
-start of therapy
-change in dose
-change in route of administration
-change in potentially interacting drugs
 
Posaconazole start/change date: Sunday Monday Tuesday Wednesday Thursday Friday Saturday
Posaconazole (assumes dose is given before noon):  Thursday Sunday Sunday Sunday Tuesday Tuesday Thursday

Synonyms

  • Posanol, Noxafil

Sample Type

Serum

Collect

Red top

Amount to Collect

2 mL blood

Preferred Volume

1 mL serum

Minimum Volume

0.3 mL serum

Remarks

In most cases, a single trough level of posaconazole should be adequate. This level should be drawn after at least seven days of posaconazole (steady state is 7-10 days) have been administered.

Posaconazole should be administered with food or nutritional supplement. The level should be drawn from 11-12 hours after the previous dose and less than one hour prior to the next dose. Peak levels should only be drawn in special circumstances.

Stability (from collection to initiation)

Refrigerated: 1 week
Frozen: 6 months

Test Code

PSCA

Performing Lab

China Basin Chemistry

Specimen Preparation

Refrigerate serum.

Preferred Volume

1 mL serum

Minimum Volume

0.3 mL serum

Stability (from collection to initiation)

Refrigerated: 1 week
Frozen: 6 months

Units

µg/mL (mcg/mL)

Reference Interval

Target Range:
Adults (≥ 18 years old):
Prophylaxis: steady-state trough >0.7 µg/mL 
Treatment: steady-state trough >1.25 µg/mL

Pediatrics (< 18 years old):
Prophylaxis: steady-state trough >0.7 µg/mL 
Treatment: steady-state trough >1.0 µg/mL

Insufficient data exists to provide an upper therapeutic range, but patients with trough levels above 5 µg/mL should be reviewed for presence of toxicity

Levels should be re-checked until a result in the therapeutic range is obtained, and after changes in doses/route/interacting drugs.  For patients on long-term posaconazole on stable doses, consider checking surveillance levels every 3 months.


References:
Ashbee HR et al. Therapeutic drug monitoring of antifungal agents: guidelines from the British Society for Medical Mycology. J Antimicrob Chemother 2014;69:1162-1176

Chau MM et al. Consensus guidelines for optimizing antifungal drug delivery and monitoring to avoid toxicity and improve outcomes in patients with haemotological malignancy, 2014.  Inten Med Journal 2014;44:1364-1388

Lewis et al. Triazole antifungal therapeutic drug monitoring.  European Conference on Infections in Leukemia. 2015. 

Hamada et al. Practice Guidelines for therapeutic drug monitoring of voriconazole: a consensus review of the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring. Journal of Infection and Chemotherapy. 2013; 19(3): 381-392.

Additional Information

Background
Posaconazole is a triazole antifungal agent with potent activity against yeasts and molds. It is proven to be effective in the prophylaxis of invasive fungal infections in immunocompromised patients, and is considered an alternative treatment for zygomyces, invasive Aspergillus infections, Candida and other infections caused by pathogenic yeasts.
Posaconazole was originally available only as an oral suspension with limited bioavailability.  A delayed-release tablet formulation with improved absorption and an intravenous formulation are now available.  The oral suspension and delayed-release tablet are not directly interchangeable – consultation with ID pharmacy is strongly recommended if switching between formulations. Posaconazole is an inhibitor of cytochrome P450 3A4 and a substrate of the p-glycoprotein drug transporter.

Indications for Posaconazole TDM

1) Any use of the oral suspension for prolonged (>7 days) use for prophylaxis or treatment.

2) Use of the delayed-release tablet formulation in patients receiving the drug for prophylaxis and with one or more of the following:
- known or suspected gastrointestinal absorption abnormalities
- altered pharmacokinetics
-receipt of other drugs likely to have a significant interaction with posaconazole (e.g. phenytoin, rifabutin, carbamezapine) which cannot be discontinued without an adverse effect on patient care
- experiencing substantial hepatic toxicity (AST/ALT > 5 times upper limit of normal or total bilirubin > 3 mg/dl) while on posaconazole, with other potential causes ruled out.
- If develops concern for breakthrough infection while on prophylaxis

3) Use of the delayed-release tablet formulation or the intravenous formulation when used to treat invasive fungal infections 

When trough levels are indicated, samples should be obtained 5-7 days after: 
-start of therapy
-change in dose
-change in route of administration
-change in potentially interacting drugs
 
Posaconazole start/change date: Sunday Monday Tuesday Wednesday Thursday Friday Saturday
Posaconazole (assumes dose is given before noon):  Thursday Sunday Sunday Sunday Tuesday Tuesday Thursday

CPT Codes

80187

LDT or Modified FDA

Yes

LOINC Codes

53731-6

Available Stat

No

Test Code

PSCA

Performing Lab

China Basin Chemistry

Performed

Monday, Wednesday and Friday (excluding holidays)

In order to be run on Monday, Wednesday or Friday, samples have to be received by the lab by 5am that day.

Methodology

LC-MS/MS

Remarks

In most cases, a single trough level of posaconazole should be adequate. This level should be drawn after at least seven days of posaconazole (steady state is 7-10 days) have been administered.

Posaconazole should be administered with food or nutritional supplement. The level should be drawn from 11-12 hours after the previous dose and less than one hour prior to the next dose. Peak levels should only be drawn in special circumstances.

Collect

Red top

Amount to Collect

2 mL blood

Sample Type

Serum

Preferred Volume

1 mL serum

Minimum Volume

0.3 mL serum

Specimen Preparation

Refrigerate serum.

Units

µg/mL (mcg/mL)

Reference Interval

Target Range:
Adults (≥ 18 years old):
Prophylaxis: steady-state trough >0.7 µg/mL 
Treatment: steady-state trough >1.25 µg/mL

Pediatrics (< 18 years old):
Prophylaxis: steady-state trough >0.7 µg/mL 
Treatment: steady-state trough >1.0 µg/mL

Insufficient data exists to provide an upper therapeutic range, but patients with trough levels above 5 µg/mL should be reviewed for presence of toxicity

Levels should be re-checked until a result in the therapeutic range is obtained, and after changes in doses/route/interacting drugs.  For patients on long-term posaconazole on stable doses, consider checking surveillance levels every 3 months.


References:
Ashbee HR et al. Therapeutic drug monitoring of antifungal agents: guidelines from the British Society for Medical Mycology. J Antimicrob Chemother 2014;69:1162-1176

Chau MM et al. Consensus guidelines for optimizing antifungal drug delivery and monitoring to avoid toxicity and improve outcomes in patients with haemotological malignancy, 2014.  Inten Med Journal 2014;44:1364-1388

Lewis et al. Triazole antifungal therapeutic drug monitoring.  European Conference on Infections in Leukemia. 2015. 

Hamada et al. Practice Guidelines for therapeutic drug monitoring of voriconazole: a consensus review of the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring. Journal of Infection and Chemotherapy. 2013; 19(3): 381-392.

Synonyms

  • Posanol, Noxafil

Stability (from collection to initiation)

Refrigerated: 1 week
Frozen: 6 months

Reported

2-3 days.

Additional Information

Background
Posaconazole is a triazole antifungal agent with potent activity against yeasts and molds. It is proven to be effective in the prophylaxis of invasive fungal infections in immunocompromised patients, and is considered an alternative treatment for zygomyces, invasive Aspergillus infections, Candida and other infections caused by pathogenic yeasts.
Posaconazole was originally available only as an oral suspension with limited bioavailability.  A delayed-release tablet formulation with improved absorption and an intravenous formulation are now available.  The oral suspension and delayed-release tablet are not directly interchangeable – consultation with ID pharmacy is strongly recommended if switching between formulations. Posaconazole is an inhibitor of cytochrome P450 3A4 and a substrate of the p-glycoprotein drug transporter.

Indications for Posaconazole TDM

1) Any use of the oral suspension for prolonged (>7 days) use for prophylaxis or treatment.

2) Use of the delayed-release tablet formulation in patients receiving the drug for prophylaxis and with one or more of the following:
- known or suspected gastrointestinal absorption abnormalities
- altered pharmacokinetics
-receipt of other drugs likely to have a significant interaction with posaconazole (e.g. phenytoin, rifabutin, carbamezapine) which cannot be discontinued without an adverse effect on patient care
- experiencing substantial hepatic toxicity (AST/ALT > 5 times upper limit of normal or total bilirubin > 3 mg/dl) while on posaconazole, with other potential causes ruled out.
- If develops concern for breakthrough infection while on prophylaxis

3) Use of the delayed-release tablet formulation or the intravenous formulation when used to treat invasive fungal infections 

When trough levels are indicated, samples should be obtained 5-7 days after: 
-start of therapy
-change in dose
-change in route of administration
-change in potentially interacting drugs
 
Posaconazole start/change date: Sunday Monday Tuesday Wednesday Thursday Friday Saturday
Posaconazole (assumes dose is given before noon):  Thursday Sunday Sunday Sunday Tuesday Tuesday Thursday

CPT Codes

80187

LDT or Modified FDA

Yes

LOINC Codes

53731-6
Ordering

Available Stat

No

Performing Lab

China Basin Chemistry

Performed

Monday, Wednesday and Friday (excluding holidays)

In order to be run on Monday, Wednesday or Friday, samples have to be received by the lab by 5am that day.

Methodology

LC-MS/MS

Reported

2-3 days.

Additional Information

Background
Posaconazole is a triazole antifungal agent with potent activity against yeasts and molds. It is proven to be effective in the prophylaxis of invasive fungal infections in immunocompromised patients, and is considered an alternative treatment for zygomyces, invasive Aspergillus infections, Candida and other infections caused by pathogenic yeasts.
Posaconazole was originally available only as an oral suspension with limited bioavailability.  A delayed-release tablet formulation with improved absorption and an intravenous formulation are now available.  The oral suspension and delayed-release tablet are not directly interchangeable – consultation with ID pharmacy is strongly recommended if switching between formulations. Posaconazole is an inhibitor of cytochrome P450 3A4 and a substrate of the p-glycoprotein drug transporter.

Indications for Posaconazole TDM

1) Any use of the oral suspension for prolonged (>7 days) use for prophylaxis or treatment.

2) Use of the delayed-release tablet formulation in patients receiving the drug for prophylaxis and with one or more of the following:
- known or suspected gastrointestinal absorption abnormalities
- altered pharmacokinetics
-receipt of other drugs likely to have a significant interaction with posaconazole (e.g. phenytoin, rifabutin, carbamezapine) which cannot be discontinued without an adverse effect on patient care
- experiencing substantial hepatic toxicity (AST/ALT > 5 times upper limit of normal or total bilirubin > 3 mg/dl) while on posaconazole, with other potential causes ruled out.
- If develops concern for breakthrough infection while on prophylaxis

3) Use of the delayed-release tablet formulation or the intravenous formulation when used to treat invasive fungal infections 

When trough levels are indicated, samples should be obtained 5-7 days after: 
-start of therapy
-change in dose
-change in route of administration
-change in potentially interacting drugs
 
Posaconazole start/change date: Sunday Monday Tuesday Wednesday Thursday Friday Saturday
Posaconazole (assumes dose is given before noon):  Thursday Sunday Sunday Sunday Tuesday Tuesday Thursday

Synonyms

  • Posanol, Noxafil
Collection

Sample Type

Serum

Collect

Red top

Amount to Collect

2 mL blood

Preferred Volume

1 mL serum

Minimum Volume

0.3 mL serum

Remarks

In most cases, a single trough level of posaconazole should be adequate. This level should be drawn after at least seven days of posaconazole (steady state is 7-10 days) have been administered.

Posaconazole should be administered with food or nutritional supplement. The level should be drawn from 11-12 hours after the previous dose and less than one hour prior to the next dose. Peak levels should only be drawn in special circumstances.

Stability (from collection to initiation)

Refrigerated: 1 week
Frozen: 6 months
Processing

Test Code

PSCA

Performing Lab

China Basin Chemistry

Specimen Preparation

Refrigerate serum.

Preferred Volume

1 mL serum

Minimum Volume

0.3 mL serum

Stability (from collection to initiation)

Refrigerated: 1 week
Frozen: 6 months
Result Interpretation

Units

µg/mL (mcg/mL)

Reference Interval

Target Range:
Adults (≥ 18 years old):
Prophylaxis: steady-state trough >0.7 µg/mL 
Treatment: steady-state trough >1.25 µg/mL

Pediatrics (< 18 years old):
Prophylaxis: steady-state trough >0.7 µg/mL 
Treatment: steady-state trough >1.0 µg/mL

Insufficient data exists to provide an upper therapeutic range, but patients with trough levels above 5 µg/mL should be reviewed for presence of toxicity

Levels should be re-checked until a result in the therapeutic range is obtained, and after changes in doses/route/interacting drugs.  For patients on long-term posaconazole on stable doses, consider checking surveillance levels every 3 months.


References:
Ashbee HR et al. Therapeutic drug monitoring of antifungal agents: guidelines from the British Society for Medical Mycology. J Antimicrob Chemother 2014;69:1162-1176

Chau MM et al. Consensus guidelines for optimizing antifungal drug delivery and monitoring to avoid toxicity and improve outcomes in patients with haemotological malignancy, 2014.  Inten Med Journal 2014;44:1364-1388

Lewis et al. Triazole antifungal therapeutic drug monitoring.  European Conference on Infections in Leukemia. 2015. 

Hamada et al. Practice Guidelines for therapeutic drug monitoring of voriconazole: a consensus review of the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring. Journal of Infection and Chemotherapy. 2013; 19(3): 381-392.

Additional Information

Background
Posaconazole is a triazole antifungal agent with potent activity against yeasts and molds. It is proven to be effective in the prophylaxis of invasive fungal infections in immunocompromised patients, and is considered an alternative treatment for zygomyces, invasive Aspergillus infections, Candida and other infections caused by pathogenic yeasts.
Posaconazole was originally available only as an oral suspension with limited bioavailability.  A delayed-release tablet formulation with improved absorption and an intravenous formulation are now available.  The oral suspension and delayed-release tablet are not directly interchangeable – consultation with ID pharmacy is strongly recommended if switching between formulations. Posaconazole is an inhibitor of cytochrome P450 3A4 and a substrate of the p-glycoprotein drug transporter.

Indications for Posaconazole TDM

1) Any use of the oral suspension for prolonged (>7 days) use for prophylaxis or treatment.

2) Use of the delayed-release tablet formulation in patients receiving the drug for prophylaxis and with one or more of the following:
- known or suspected gastrointestinal absorption abnormalities
- altered pharmacokinetics
-receipt of other drugs likely to have a significant interaction with posaconazole (e.g. phenytoin, rifabutin, carbamezapine) which cannot be discontinued without an adverse effect on patient care
- experiencing substantial hepatic toxicity (AST/ALT > 5 times upper limit of normal or total bilirubin > 3 mg/dl) while on posaconazole, with other potential causes ruled out.
- If develops concern for breakthrough infection while on prophylaxis

3) Use of the delayed-release tablet formulation or the intravenous formulation when used to treat invasive fungal infections 

When trough levels are indicated, samples should be obtained 5-7 days after: 
-start of therapy
-change in dose
-change in route of administration
-change in potentially interacting drugs
 
Posaconazole start/change date: Sunday Monday Tuesday Wednesday Thursday Friday Saturday
Posaconazole (assumes dose is given before noon):  Thursday Sunday Sunday Sunday Tuesday Tuesday Thursday
Administrative

CPT Codes

80187

LDT or Modified FDA

Yes

LOINC Codes

53731-6
Complete View

Available Stat

No

Test Code

PSCA

Performing Lab

China Basin Chemistry

Performed

Monday, Wednesday and Friday (excluding holidays)

In order to be run on Monday, Wednesday or Friday, samples have to be received by the lab by 5am that day.

Methodology

LC-MS/MS

Remarks

In most cases, a single trough level of posaconazole should be adequate. This level should be drawn after at least seven days of posaconazole (steady state is 7-10 days) have been administered.

Posaconazole should be administered with food or nutritional supplement. The level should be drawn from 11-12 hours after the previous dose and less than one hour prior to the next dose. Peak levels should only be drawn in special circumstances.

Collect

Red top

Amount to Collect

2 mL blood

Sample Type

Serum

Preferred Volume

1 mL serum

Minimum Volume

0.3 mL serum

Specimen Preparation

Refrigerate serum.

Units

µg/mL (mcg/mL)

Reference Interval

Target Range:
Adults (≥ 18 years old):
Prophylaxis: steady-state trough >0.7 µg/mL 
Treatment: steady-state trough >1.25 µg/mL

Pediatrics (< 18 years old):
Prophylaxis: steady-state trough >0.7 µg/mL 
Treatment: steady-state trough >1.0 µg/mL

Insufficient data exists to provide an upper therapeutic range, but patients with trough levels above 5 µg/mL should be reviewed for presence of toxicity

Levels should be re-checked until a result in the therapeutic range is obtained, and after changes in doses/route/interacting drugs.  For patients on long-term posaconazole on stable doses, consider checking surveillance levels every 3 months.


References:
Ashbee HR et al. Therapeutic drug monitoring of antifungal agents: guidelines from the British Society for Medical Mycology. J Antimicrob Chemother 2014;69:1162-1176

Chau MM et al. Consensus guidelines for optimizing antifungal drug delivery and monitoring to avoid toxicity and improve outcomes in patients with haemotological malignancy, 2014.  Inten Med Journal 2014;44:1364-1388

Lewis et al. Triazole antifungal therapeutic drug monitoring.  European Conference on Infections in Leukemia. 2015. 

Hamada et al. Practice Guidelines for therapeutic drug monitoring of voriconazole: a consensus review of the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring. Journal of Infection and Chemotherapy. 2013; 19(3): 381-392.

Synonyms

  • Posanol, Noxafil

Stability (from collection to initiation)

Refrigerated: 1 week
Frozen: 6 months

Reported

2-3 days.

Additional Information

Background
Posaconazole is a triazole antifungal agent with potent activity against yeasts and molds. It is proven to be effective in the prophylaxis of invasive fungal infections in immunocompromised patients, and is considered an alternative treatment for zygomyces, invasive Aspergillus infections, Candida and other infections caused by pathogenic yeasts.
Posaconazole was originally available only as an oral suspension with limited bioavailability.  A delayed-release tablet formulation with improved absorption and an intravenous formulation are now available.  The oral suspension and delayed-release tablet are not directly interchangeable – consultation with ID pharmacy is strongly recommended if switching between formulations. Posaconazole is an inhibitor of cytochrome P450 3A4 and a substrate of the p-glycoprotein drug transporter.

Indications for Posaconazole TDM

1) Any use of the oral suspension for prolonged (>7 days) use for prophylaxis or treatment.

2) Use of the delayed-release tablet formulation in patients receiving the drug for prophylaxis and with one or more of the following:
- known or suspected gastrointestinal absorption abnormalities
- altered pharmacokinetics
-receipt of other drugs likely to have a significant interaction with posaconazole (e.g. phenytoin, rifabutin, carbamezapine) which cannot be discontinued without an adverse effect on patient care
- experiencing substantial hepatic toxicity (AST/ALT > 5 times upper limit of normal or total bilirubin > 3 mg/dl) while on posaconazole, with other potential causes ruled out.
- If develops concern for breakthrough infection while on prophylaxis

3) Use of the delayed-release tablet formulation or the intravenous formulation when used to treat invasive fungal infections 

When trough levels are indicated, samples should be obtained 5-7 days after: 
-start of therapy
-change in dose
-change in route of administration
-change in potentially interacting drugs
 
Posaconazole start/change date: Sunday Monday Tuesday Wednesday Thursday Friday Saturday
Posaconazole (assumes dose is given before noon):  Thursday Sunday Sunday Sunday Tuesday Tuesday Thursday

CPT Codes

80187

LDT or Modified FDA

Yes

LOINC Codes

53731-6

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