Evaluation of the safety and efficacy of micafungin in Japanese patients with deep mycosis: a post-marketing survey report

Hanadate, Tomoko; Wakasugi, Masahiro; Sogabe, Keizo; Kobayashi, Toshimitsu; Horita, Hiroki; Kawamura, Ikuo; Hori, Yasuhiro; Matsui, Keita; Hoshino, Yo; Sou, Masahiro

doi:10.1007/s10156-011-0219-0

Cited by 20 publications

(18 citation statements)

References 24 publications

(37 reference statements)

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“…long as 20 weeks may be well tolerated, even in patients with baseline liver impairment. Indeed, when patients were examined separately based on their baseline liver function (normal vs abnormal baseline liver function), there was no deterioration of liver function in any of the 2 groups from baseline to EOT, consistent with previously reported data [11]. Due to the large variability in the way micafungin was administered, we specifically investigated a subgroup of patients who received >75% of their course as 300 mg micafungin 3 times weekly.…”

Section: Discussionmentioning

confidence: 82%

Safety and Efficacy of Intermittent Intravenous Administration of High-Dose Micafungin

Neofytos

Huang

Cheng

et al. 2015

Clinical Infectious Diseases

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Background. The use of mold-active azoles for antifungal prophylaxis after allogeneic stem cell transplantation (SCT) is hindered by adverse events and drug-drug interactions. Higher doses of echinocandins administered intermittently may be an alternative in this setting.Methods. This was a single-center, observational 5-year study to characterize the safety and efficacy of intermittent administration of high-dose intravenous micafungin (≥5 doses of ≥300 mg micafungin 2-3 times weekly) in patients with acute leukemia and allogeneic SCT recipients.Results. A total of 104 patients (84 allogeneic SCT recipients and 20 patients with leukemia) received intermittent high-dose intravenous micafungin, 83 (79.8%) as prophylaxis. Large variability in the micafungin dosing regimen was observed; 78 (75%) patients received >75% of their course as 300 mg micafungin 3 times weekly. Liver function tests decreased from baseline to end of treatment (EOT; P < .001). Patients with normal baseline liver function (n = 55 [52%]) maintained similar enzyme levels throughout the study. For patients with abnormal baseline liver function (n = 49 [47%]), liver function tests significantly improved from baseline to EOT (P ≤ .005). Duration and/or micafungin dosing algorithms were not associated with liver toxicity at EOT. There were no significant changes in renal function, and infusion-related reactions or deaths were not observed. Five of 83 (6.0%) patients in the prophylaxis group developed a breakthrough fungal infection.Conclusions. In this largest cohort of patients to date, intermittent administration of high-dose micafungin was well tolerated, without any associated liver or renal function abnormalities, and may be considered an alternative antifungal prophylactic strategy. Prospective studies are needed to further validate these findings.

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Section: Discussionmentioning

confidence: 82%

Safety and Efficacy of Intermittent Intravenous Administration of High-Dose Micafungin

Neofytos

Huang

Cheng

et al. 2015

Clinical Infectious Diseases

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“…The incidence of adverse drug reactions was 35.7%, with hepatobiliary disorders the most common adverse drug reactions (17.8%). In a Japanese post-marketing surveillance study in adult patients with deep mycosis, the incidence of adverse drug reactions was 28.5%, with hepatobiliary disorders occurring in 16.8% of patients [8]. In a multinational Phase III trial that compared micafungin with liposomal amphotericin B for the treatment of candidemia and invasive candidosis, 43.2% and 50.9% of patients had treatment-related adverse reactions in micafungin-treated and liposomal amphotericin B-treated group, respectively [10].…”

Section: Discussionmentioning

confidence: 98%

“…Excluded from the safety analysis, n = 10 Insufficient safety data for assessment (8) Contract not concluded with the site (1) No MCFG administration (1)…”

Section: Patients Enrolled N = 251mentioning

confidence: 99%

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

Kobayashi

Hanadate

Niwa

et al. 2015

Journal of Infection and Chemotherapy

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“…The caspofungin doses investigated in this study were the same as the approved clinical doses outside of Japan. Although the approved standard dose of micafungin for aspergillosis and candidiasis is 50–150 mg once daily and 50 mg once daily, respectively, and the dose can be increased up to 300 mg once daily in Japan, the average daily micafungin dose which has been actually used in a clinical setting is reported to be 110 mg [14]. In addition, in the Japanese “Diagnosis and Treatment Guideline for Deep-Seated Fungal Infections”, micafungin doses of 100 to 150 mg daily and 150 to 300 mg daily are recommended for the treatment of candidiasis and aspergillosis, respectively [15].…”

Section: Discussionmentioning

confidence: 99%

A double-blind comparative study of the safety and efficacy of caspofungin versus micafungin in the treatment of candidiasis and aspergillosis

Kohno

Izumikawa

Yoshida

et al. 2012

Eur J Clin Microbiol Infect Dis

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The safety and efficacy profile of caspofungin and micafungin in Japanese patients with fungal infections were directly compared in this prospective, randomized, double-blind study. The proportion of patients who developed significant drug-related adverse event(s) (defined as a serious drug-related adverse event or a drug-related adverse event leading to study therapy discontinuation) was compared in 120 patients [caspofungin 50 mg, or 50 mg following a 70-mg loading dose on Day 1 (hereinafter, 70/50 mg) group: 60 patients; micafungin 150 mg: 60 patients]. The overall response rate was primarily evaluated in the per-protocol set (PPS) population. The proportion of patients who developed significant drug-related adverse events was 5.0 % (3/60) in the caspofungin group and 10.0 % (6/60) in the micafungin group [95 % confidence interval (CI) for the difference: −15.9 %, 5.2 %]. The favorable overall response in the PPS population for patients with esophageal candidiasis, invasive candidiasis, and chronic pulmonary aspergillosis including aspergilloma was 100.0 % (6/6), 100.0 % (3/3), and 46.7 % (14/30) in the caspofungin group, and 83.3 % (5/6), 100.0 % (1/1), and 42.4 % (14/33) in the micafungin group, respectively. In Japanese patients with Candida or Aspergillus infections, there was no statistical difference in the safety between caspofungin and micafungin. Consistent with other data on these two agents, the efficacy of caspofungin and micafungin was similar.

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Evaluation of the safety and efficacy of micafungin in Japanese patients with deep mycosis: a post-marketing survey report

Cited by 20 publications

References 24 publications

Safety and Efficacy of Intermittent Intravenous Administration of High-Dose Micafungin

Safety and Efficacy of Intermittent Intravenous Administration of High-Dose Micafungin

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

A double-blind comparative study of the safety and efficacy of caspofungin versus micafungin in the treatment of candidiasis and aspergillosis

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