Safety and efficacy of micafungin for prophylaxis against invasive fungal infections in Japanese patients undergoing hematopoietic stem cell transplantation: Results of a post-marketing surveillance study.
Invasive fungal infections are a major cause of morbidity and mortality in patients with hematopoietic stem cell transplantation. A prospective multicenter post-marketing observational surveillance study was conducted from July 2007 to June 2010 to assess the safety and efficacy of micafungin, an echinocandin antifungal, for prophylaxis against invasive fungal infections in Japanese patients undergoing hematopoietic stem cell transplantation. Among 241 patients evaluated for safety, 143 adverse drug reactions were reported in 86 patients (35.7%), with hepatobiliary disorders the most frequently reported adverse drug reactions. The success rate for prophylaxis at the end of observation was 72.8% (131/180 patients), and the incidence of breakthrough infections was only 4.4% (8/180 patients). In conclusion, micafungin had sufficient safety and efficacy for prophylaxis against invasive fungal infections in Japanese patients with various backgrounds undergoing hematopoietic stem cell transplantation.
Medical Affairs, Astellas Pharma Inc., 2-5-1, Nihonbashihoncho, Chuo-ku, Tokyo 103-8411, Japan. Electronic address: chie.kobayashi@astellas.com.
Chie
C
Kobayashi
Pharmacovigilance, Astellas Pharma Inc., Tokyo, Japan.
Tomoko
T
Hanadate
Formerly of Astellas Pharma Inc., Tokyo, Japan.
Toshiro
T
Niwa
Medical Affairs, Astellas Pharma Inc., 2-5-1, Nihonbashihoncho, Chuo-ku, Tokyo 103-8411, Japan.
Yasuno
Y
Hirano
Medical Affairs, Astellas Pharma Inc., 2-5-1, Nihonbashihoncho, Chuo-ku, Tokyo 103-8411, Japan.
Takashi
T
Yoshiyasu
Medical Affairs, Astellas Pharma Inc., 2-5-1, Nihonbashihoncho, Chuo-ku, Tokyo 103-8411, Japan.
Masahiro
M
So
Medical Affairs, Astellas Pharma Inc., 2-5-1, Nihonbashihoncho, Chuo-ku, Tokyo 103-8411, Japan.
Keita
K
Matsui
D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D044466:Asian People; D002648:Child; D002675:Child, Preschool; D054714:Echinocandins / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D055666:Lipopeptides / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D000077551:Micafungin; D008875:Middle Aged; D009181:Mycoses / Q000188:drug therapy*; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D055815:Young Adult
D000935:Antifungal Agents; D054714:Echinocandins; D055666:Lipopeptides; D000077551:Micafungin
Antifungal; Efficacy; Micafungin; Safety