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.