Safety of high-dose micafungin for patients with hematological diseases.
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.
Department of Hematology and Oncology, Graduate School of Medicine, The University of Tokyo , Tokyo , Japan.
Sho
S
Yamazaki
Fumihiko
F
Nakamura
Akihide
A
Yoshimi
Motoshi
M
Ichikawa
Yasuhito
Y
Nannya
Mineo
M
Kurokawa
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology; D003967:Diarrhea / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D054714:Echinocandins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006402:Hematologic Diseases / Q000150:complications*; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D055666:Lipopeptides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D000077551:Micafungin; D008875:Middle Aged; D009181:Mycoses / Q000150:complications / Q000188:drug therapy*; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
D000935:Antifungal Agents; D054714:Echinocandins; D055666:Lipopeptides; D000077551:Micafungin
Micafungin; adverse events; hepatotoxicity; high dose; safety