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Safety of high-dose micafungin for patients with hematological diseases
Sho Yamazaki1, Fumihiko Nakamura, Akihide Yoshimi
1Department of Hematology and Oncology, Graduate School of Medicine, The University of Tokyo , Tokyo , Japan.
Abstract:
This study was conducted as a retrospective, observational, exploratory cohort study with the aim of elucidating the safety profile of micafungin at doses exceeding 150 mg daily. We identified adult patients with hematological diseases who had received micafungin therapy for ≥ 7 consecutive days. Twenty-six patients administered micafungin at 300 mg daily (high-dose group) were compared with 58 patients administered micafungin at 150 mg daily (standard-dose group). The most frequent adverse events (AEs) were hepatotoxicity, hypertension and diarrhea. AEs were recorded in 42 (72%) and 19 (73%) patients in the standard-dose and high-dose groups, respectively (p = 1.00). Hepatobiliary AEs were noted in 28 (48%) and 15 (58%) patients, respectively (p = 0.48). Serious AEs and resultant treatment discontinuation were infrequent. Our results suggest that micafungin was safe and well tolerated at 300 mg daily.
Insights
Micafungin at 300 mg daily is safe for patients with hematological diseases. Adverse events were similar to the 150 mg dose, with no increase in serious issues.
Area of Science:
- Pharmacology
- Clinical Medicine
- Infectious Diseases
Background:
- Micafungin is an echinocandin antifungal agent.
- Its safety at doses exceeding 150 mg daily requires further elucidation, particularly in specific patient populations.
Purpose of the Study:
- To evaluate the safety and tolerability of high-dose micafungin (300 mg daily) compared to standard-dose (150 mg daily).
- To assess adverse events in adult patients with hematological diseases receiving micafungin therapy.
Main Methods:
- Retrospective, observational, exploratory cohort study.
- Comparison of 26 patients receiving micafungin 300 mg/day with 58 patients receiving 150 mg/day for ≥ 7 days.
- Analysis of adverse events, including hepatotoxicity, hypertension, and diarrhea.
Main Results:
- Adverse events occurred in 72% of the standard-dose group and 73% of the high-dose group (p = 1.00).
- Hepatobiliary adverse events were observed in 48% and 58% of patients, respectively (p = 0.48).
- Serious adverse events and treatment discontinuation were infrequent in both groups.
Conclusions:
- Micafungin at 300 mg daily appears safe and well-tolerated in adult patients with hematological diseases.
- The safety profile at higher doses is comparable to the standard dose.
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