Longitudinal changes in laboratory parameters and QTc during isavuconazole therapy in Japanese patients with
Koichi Ohata1, Ryo Kobayashi1,2, Daichi Watanabe1
1Department of Pharmacy, Gifu University Hospital, Gifu, Japan.
Background:
Isavuconazole (ISCZ) is an azole antifungal with a low risk of QTc prolongation and no requirement for renal dose adjustment. However, real-world data in Asian patients remain limited.
Methods:
We retrospectively evaluated 45 patients who received ISCZ between April 2023 and March 2025. Laboratory parameters and QTc values (QTcB/QTcF) were extracted from medical records. Longitudinal changes were assessed using linear mixed-effects models. In patients receiving arsenic trioxide (ATO), QTc trajectories were compared among ATO alone, ATO with ISCZ (ATO-ISCZ), and ATO with other antifungals.
Results:
Grade ≥2 elevations in AST and ALT occurred in 11.1% and 13.3% of patients, respectively, and were transient. No significant deterioration in laboratory parameters was observed. In the ATO subgroup, QTc values in the ATO-ISCZ group were lower than those in the ATO group from Day 30, with the largest difference at Day 70 (-45.5 ms for QTcB and -42.3 ms for QTcF; both p < 0.001). The ATO-other antifungals group showed similar trends to the ATO group. No clinically significant cardiac events were observed.
Conclusions:
ISCZ showed a favorable safety profile in Japanese patients with hematologic malignancies and may be a safe option during QT-prolonging therapies.
Insights
Isavuconazole (ISCZ) is a safe antifungal for Japanese patients with hematologic malignancies. It demonstrated a favorable safety profile, even when used with QT-prolonging therapies like arsenic trioxide.
Area of Science:
- Pharmacology
- Clinical Medicine
- Infectious Diseases
Background:
- Isavuconazole (ISCZ) is an azole antifungal known for low QTc prolongation risk and no need for renal dose adjustment.
- Limited real-world data exists for ISCZ in Asian patient populations.
Purpose of the Study:
- To evaluate the safety and efficacy of Isavuconazole (ISCZ) in Japanese patients with hematologic malignancies.
- To assess the impact of ISCZ on QTc interval, particularly when co-administered with arsenic trioxide (ATO).
Main Methods:
- Retrospective evaluation of 45 patients receiving ISCZ between April 2023 and March 2025.
- Analysis of laboratory parameters and QTc values (QTcB/QTcF) using linear mixed-effects models.
- Comparison of QTc trajectories in patients receiving ATO alone, ATO with ISCZ, and ATO with other antifungals.
Main Results:
- Transient, grade ≥2 elevations in AST (11.1%) and ALT (13.3%) were observed, with no significant laboratory deterioration.
- In the ATO subgroup, ISCZ was associated with lower QTc values compared to ATO alone (p < 0.001).
- No clinically significant cardiac events were reported during the study period.
Conclusions:
- Isavuconazole (ISCZ) exhibits a favorable safety profile in Japanese patients with hematologic malignancies.
- ISCZ appears to be a safe therapeutic option, even during concurrent QT-prolonging treatments.
Related Concept Videos
Therapeutic Drug Monitoring: Affecting Factors
Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test
Dosage Regimens: Partial Pharmacokinetic Parameters
Antiarrhythmic Drugs: Class III Agents as Potassium Channel Blockers
Drug Accumulation During Multiple Dosing: Intermittent IV Infusions
Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment
