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Isavuconazole Kinetic Exploration for Clinical Practice
Léa Darnaud1, Fabien Lamoureux2, Cendrine Godet3
1Laboratoire de Pharmacocinétique et Toxicologie, Institut Fédératif de Biologie, 330 Avenue Grande Bretagne, 31059, Toulouse Cedex 09, France.
Drugs in R&D
|October 12, 2018
Summary
Early pharmacokinetic profiling of isavuconazole (ISA) can identify patients with outlier profiles. This approach helps clinicians assess drug exposure and efficacy, especially for new antifungal treatments like ISA.
Area of Science:
- Pharmacology
- Mycology
- Clinical Pharmacy
Background:
- Isavuconazole is a novel antifungal prodrug for invasive aspergillosis and mucormycosis.
- Therapeutic drug monitoring for isavuconazole is not routinely required due to an undefined pharmacokinetic-pharmacodynamic relationship.
- Clinicians often seek pharmacokinetic data to confirm adequate drug exposure in patients.
Purpose of the Study:
- To evaluate a method for estimating patient isavuconazole pharmacokinetic profiles using a single concentration measurement.
- To identify patients with potentially outlier pharmacokinetic profiles early in treatment.
- To guide potential therapeutic drug monitoring and dosage adjustments.
Main Methods:
- Utilized a population pharmacokinetic model (Desai et al.) with a single patient concentration to estimate the pharmacokinetic profile.
- Compared individual patient profiles to established population profiles from the SECURE study.
- Investigated outlier profiles and their potential causes, including drug interactions and genetic polymorphisms.
Main Results:
- Four patients exhibited unexpected pharmacokinetic profiles not explained by known factors.
- Dosage adjustments were made for two patients based on their pharmacokinetic profiles.
- Follow-up pharmacokinetic assessments were conducted after dosage adjustments.
Conclusions:
- A single pre-dose blood sample before the first maintenance dose can estimate a patient's pharmacokinetic profile.
- This method aids in the early identification of patients with outlier isavuconazole exposure.
- Facilitates informed clinical decisions regarding isavuconazole therapy and monitoring.
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