Pharmacokinetics, efficacy, and safety of caspofungin in Japanese pediatric patients with invasive candidiasis and invasive aspergillosis

Masaaki Mori, Masue Imaizumi, Naruhiko Ishiwada, Takashi Kaneko, Hiroaki Goto, Koji Kato, Junichi Hara, Yoshiyuki Kosaka, Kazutoshi Koike, Hiroshi Kawamoto, Naoko Maeda, Tomoko Yoshinari, Hiroyuki Kishino, Kenichi Takahashi, Shizuko Kawahara, Nicholas A. Kartsonis, Yoshihiro Komada

    研究成果: ジャーナルへの寄稿記事

    2 引用 (Scopus)

    抄録

    The antifungal agents approved in Japan for pediatric use are limited and many unapproved drugs are actually used without clear instruction for dosage. We investigated the pharmacokinetics of caspofungin for the treatment of invasive candidiasis and invasive aspergillosis in 20 Japanese pediatric patients using a pediatric-specific dosage based on body surface area. Caspofungin was administered intravenously over 60min as 70mg/m2 on Day 1, followed by 50mg/m2 per day. Five or 4 point blood sampling were done in 15 patients on Day 4-5 to calculate AUC0-24h. The geometric means (95% confidence interval) of C24h and AUC0-24h in the pediatric patients were 3.3(2.5, 4.4)μg/mL and 175.1 (139.3, 220.1)μghr/mL, respectively, which were comparable to those in Japanese adult patients [3.2 (2.8, 3.5)μg/mL and 144.9 (131.7, 159.3)μghr/mL, respectively]. Among the 20 patients, 10 (50%) had at least 1 drug-related adverse event which was considered related to caspofungin therapy. No drug-related serious adverse event and no death occurred. The most common drug-related adverse events were events relating to hepatic function (mainly increases in ALT and AST). The overall success in efficacy was observed in 13 of 20 patients. In conclusion, once daily administration of caspofungin (70mg/m2 on Day 1, followed by 50mg/m2 [maximum daily dose not to exceed 70mg]), which is the same dosage being used in overseas, achieved sufficient drug exposure and a favorable efficacy and acceptable safety profile in Japanese pediatric patients with invasive fungal infections.

    元の言語英語
    ページ(範囲)421-426
    ページ数6
    ジャーナルJournal of Infection and Chemotherapy
    21
    発行部数6
    DOI
    出版物ステータス出版済み - 6 1 2015

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    caspofungin
    Invasive Candidiasis
    Aspergillosis
    Pharmacokinetics
    Pediatrics
    Safety
    Drug-Related Side Effects and Adverse Reactions
    Pharmaceutical Preparations
    Antifungal Agents
    Body Surface Area
    Japan

    All Science Journal Classification (ASJC) codes

    • Microbiology (medical)
    • Pharmacology (medical)
    • Infectious Diseases

    これを引用

    Pharmacokinetics, efficacy, and safety of caspofungin in Japanese pediatric patients with invasive candidiasis and invasive aspergillosis. / Mori, Masaaki; Imaizumi, Masue; Ishiwada, Naruhiko; Kaneko, Takashi; Goto, Hiroaki; Kato, Koji; Hara, Junichi; Kosaka, Yoshiyuki; Koike, Kazutoshi; Kawamoto, Hiroshi; Maeda, Naoko; Yoshinari, Tomoko; Kishino, Hiroyuki; Takahashi, Kenichi; Kawahara, Shizuko; Kartsonis, Nicholas A.; Komada, Yoshihiro.

    :: Journal of Infection and Chemotherapy, 巻 21, 番号 6, 01.06.2015, p. 421-426.

    研究成果: ジャーナルへの寄稿記事

    Mori, M, Imaizumi, M, Ishiwada, N, Kaneko, T, Goto, H, Kato, K, Hara, J, Kosaka, Y, Koike, K, Kawamoto, H, Maeda, N, Yoshinari, T, Kishino, H, Takahashi, K, Kawahara, S, Kartsonis, NA & Komada, Y 2015, 'Pharmacokinetics, efficacy, and safety of caspofungin in Japanese pediatric patients with invasive candidiasis and invasive aspergillosis', Journal of Infection and Chemotherapy, 巻. 21, 番号 6, pp. 421-426. https://doi.org/10.1016/j.jiac.2015.01.009
    Mori, Masaaki ; Imaizumi, Masue ; Ishiwada, Naruhiko ; Kaneko, Takashi ; Goto, Hiroaki ; Kato, Koji ; Hara, Junichi ; Kosaka, Yoshiyuki ; Koike, Kazutoshi ; Kawamoto, Hiroshi ; Maeda, Naoko ; Yoshinari, Tomoko ; Kishino, Hiroyuki ; Takahashi, Kenichi ; Kawahara, Shizuko ; Kartsonis, Nicholas A. ; Komada, Yoshihiro. / Pharmacokinetics, efficacy, and safety of caspofungin in Japanese pediatric patients with invasive candidiasis and invasive aspergillosis. :: Journal of Infection and Chemotherapy. 2015 ; 巻 21, 番号 6. pp. 421-426.
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    abstract = "The antifungal agents approved in Japan for pediatric use are limited and many unapproved drugs are actually used without clear instruction for dosage. We investigated the pharmacokinetics of caspofungin for the treatment of invasive candidiasis and invasive aspergillosis in 20 Japanese pediatric patients using a pediatric-specific dosage based on body surface area. Caspofungin was administered intravenously over 60min as 70mg/m2 on Day 1, followed by 50mg/m2 per day. Five or 4 point blood sampling were done in 15 patients on Day 4-5 to calculate AUC0-24h. The geometric means (95{\%} confidence interval) of C24h and AUC0-24h in the pediatric patients were 3.3(2.5, 4.4)μg/mL and 175.1 (139.3, 220.1)μghr/mL, respectively, which were comparable to those in Japanese adult patients [3.2 (2.8, 3.5)μg/mL and 144.9 (131.7, 159.3)μghr/mL, respectively]. Among the 20 patients, 10 (50{\%}) had at least 1 drug-related adverse event which was considered related to caspofungin therapy. No drug-related serious adverse event and no death occurred. The most common drug-related adverse events were events relating to hepatic function (mainly increases in ALT and AST). The overall success in efficacy was observed in 13 of 20 patients. In conclusion, once daily administration of caspofungin (70mg/m2 on Day 1, followed by 50mg/m2 [maximum daily dose not to exceed 70mg]), which is the same dosage being used in overseas, achieved sufficient drug exposure and a favorable efficacy and acceptable safety profile in Japanese pediatric patients with invasive fungal infections.",
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    AU - Mori, Masaaki

    AU - Imaizumi, Masue

    AU - Ishiwada, Naruhiko

    AU - Kaneko, Takashi

    AU - Goto, Hiroaki

    AU - Kato, Koji

    AU - Hara, Junichi

    AU - Kosaka, Yoshiyuki

    AU - Koike, Kazutoshi

    AU - Kawamoto, Hiroshi

    AU - Maeda, Naoko

    AU - Yoshinari, Tomoko

    AU - Kishino, Hiroyuki

    AU - Takahashi, Kenichi

    AU - Kawahara, Shizuko

    AU - Kartsonis, Nicholas A.

    AU - Komada, Yoshihiro

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