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An Overview of Isavuconazole Clinical Use: A Multicentre Analysis of Indications, Exposure and Hepatic Safety
Anne-Lise Bienvenu1,2, Alexandra Duffour3, Claire Chatron4
1Service de Pharmacie, Groupement Hospitalier Nord, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, 103 grande rue de la Croix-Rousse, 69004, Lyon, France. anne-lise.bienvenu@chu-lyon.fr.
Background:
Isavuconazole is a recent broad-spectrum triazole indicated for the treatment of invasive aspergillosis and mucormycosis when amphotericin B is inappropriate. However, limited information exists on its clinical use.
Objective:
We set up a retrospective multicentre study to describe the clinical practice of isavuconazole including indications, exposure, and hepatic safety.
Methods:
From January 2021 to June 2023, all patients who received isavuconazole and had at least one therapeutic drug monitoring (TDM) measurement, were included. To identify independent predictors of isavuconazole trough concentrations (Cmin), linear regression analyses were performed. Causal relationship between the occurrence of liver injury and isavuconazole was also analysed.
Results:
Most of the included patients (n = 102) were admitted into haematology units (41.1% [n = 42]) or intensive care units (ICU) (30.4% [n = 31]). Aspergillosis (47.0% [n = 48]), mucormycosis (25.6% [n = 26]), and off-label empirical treatments (18.6% [n = 19]), were the three most common indications. About half of the patients (46.1% [n = 47]) had an optimal exposure, while 42.2% (n = 43) were underexposed, and 11.7% (n = 12) were overexposed. Albumin level on the day of TDM was a significant factor associated with an increase in isavuconazole Cmin (p = 0.010). Among the 11 patients who had liver test abnormalities, isavuconazole was discontinued in six (n = 6) patients and liver injury was attributable to isavuconazole in two (n = 2) patients.
Conclusions:
This multicentre analysis highlighted the common use of isavuconazole as an off-label indication, as well as the frequent underexposure of patients to isavuconazole. Albumin on the day of TDM appeared to be an important factor driving isavuconazole exposure, especially in ICU patients.
Insights
This study found frequent under-exposure to isavuconazole, an antifungal medication, particularly in ICU patients. Albumin levels significantly impact isavuconazole drug exposure, guiding optimal dosing strategies.
Area of Science:
- Pharmacology
- Infectious Diseases
- Clinical Pharmacy
Background:
- Isavuconazole is a broad-spectrum triazole antifungal used for invasive aspergillosis and mucormycosis.
- Limited data exists on its real-world clinical application and patient exposure.
Purpose of the Study:
- To describe clinical practices with isavuconazole.
- To evaluate patient exposure and hepatic safety.
- To identify factors influencing isavuconazole trough concentrations.
Main Methods:
- Retrospective multicenter study (January 2021 - June 2023).
- Included 102 patients with therapeutic drug monitoring (TDM).
- Linear regression analysis for predictors of isavuconazole Cmin; liver injury causality assessed.
Main Results:
- Common indications: Aspergillosis (47%), mucormycosis (25.6%), off-label empirical treatment (18.6%).
- 42.2% of patients were underexposed, 11.7% overexposed.
- Low albumin levels correlated with increased isavuconazole Cmin (p=0.010); 2 cases of liver injury attributed to isavuconazole.
Conclusions:
- Isavuconazole is frequently used off-label.
- Patient underexposure is common, necessitating TDM.
- Albumin levels are a key factor for optimizing isavuconazole exposure, especially in ICU settings.
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