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Therapeutic Drug Monitoring of Isavuconazole: Lessons Learnt from a Real-life Setting in a Tertiary Care Center in
Parikshit Shirish Prayag1, Rajeev N Soman1, Shweta P Panchakshari1
1Department of Infectious Diseases, Deenanath Mangeshkar Hospital & Research Center, Pune, Maharashtra, India.
Introduction:
Isavuconazole is an emerging therapeutic option for invasive infections caused by molds, especially aspergillosis and mucormycosis. Isavuconazole has predictable pharmacokinetics and good bioavailability. These attributes have led to some doubts regarding the need for therapeutic drug monitoring (TDM). There are no data from India regarding TDM for isavuconazole.
Methods:
A retrospective analysis of 50 patients who received oral isavuconazole for therapeutic purposes. Plasma isavuconazole levels were measured using a reversed phase high-performance liquid chromatography (HPLC) and UV detector with acetonitrile (ACN) as protein precipitating solvent.
Results:
Of the 50 cases, 5 (10.0%) patients had subtherapeutic levels, while 45 (90.0%) had therapeutic levels. Higher body weight and solid organ transplantation (SOT) were significantly associated with subtherapeutic levels of isavuconazole (p-value < 0.05 for all). Receipt of a SOT was the only independent and statistically significant factor which was associated with subtherapeutic levels of isavuconazole (p-value < 0.05).
Conclusion:
Our study reemphasizes the need of TDM for isavuconazole and adds to the growing evidence for the need to obtain drug levels. Factors associated with subtherapeutic levels of isavuconazole need to be assessed in larger studies to help identify those patients who are at risk of having subtherapeutic drug levels.
How To Cite This Article:
Prayag PS, Soman RN, Panchakshari SP, Ajapuje PS, Mahale NP, Dhupad S, et al. Therapeutic Drug Monitoring of Isavuconazole: Lessons Learnt from a Real-life Setting in a Tertiary Care Center in India. Indian J Crit Care Med 2023;27(4):260-264.
Insights
Therapeutic drug monitoring (TDM) for isavuconazole is necessary, as 10% of patients had subtherapeutic levels. Solid organ transplantation and higher body weight were linked to lower isavuconazole levels.
Area of Science:
- Pharmacology
- Infectious Diseases
- Clinical Pharmacy
Background:
- Isavuconazole is a key antifungal for invasive mold infections like aspergillosis and mucormycosis.
- Its predictable pharmacokinetics have raised questions about the necessity of therapeutic drug monitoring (TDM).
- Limited data exists on isavuconazole TDM in India.
Purpose of the Study:
- To evaluate the need for TDM of isavuconazole in a real-world Indian setting.
- To identify factors associated with subtherapeutic isavuconazole levels.
Main Methods:
- Retrospective analysis of 50 patients receiving oral isavuconazole.
- Plasma isavuconazole levels measured via HPLC with UV detection.
- Acetonitrile used as a protein precipitating solvent.
Main Results:
- 10% of patients (5/50) exhibited subtherapeutic isavuconazole levels.
- Higher body weight and solid organ transplantation (SOT) were significantly associated with subtherapeutic levels (p<0.05).
- SOT was the sole independent predictor of subtherapeutic isavuconazole levels (p<0.05).
Conclusions:
- This study reinforces the importance of TDM for isavuconazole.
- Further research with larger cohorts is needed to identify patients at risk for subtherapeutic drug levels.
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