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Int J Hematol. 2009 Nov;90(4):492-500. doi: 10.1007/s12185-009-0402-6. Epub 2009 Aug 22.

A study of rasburicase for the management of hyperuricemia in pediatric patients with newly diagnosed hematologic malignancies at high risk for tumor lysis syndrome.

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Division of Hematology/Oncology, Saitama Children's Medical Center, Saitama, Japan.
Department of Pediatrics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo Bunkyo-ku, Tokyo, 113-8655, Japan.
Department of Hemato-oncology/Regeneration Medicine, Kanagawa Children's Medical Center, Yokohama, Japan.
Department of Pediatrics, Aichi Medical University Hospital, Aichi, Japan.
Department of Hematology/Oncology, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan.
Department of Pediatrics, Fukushima Medical University Hospital, Fukushima, Japan.
Department of Pediatrics, Ibaraki Children's Hospital, Mito, Japan.
Department of Pediatrics, National Kyushu Cancer Center, Fukuoka, Japan.
Department of Pediatrics, Niigata Cancer Center Hospital, Niigata, Japan.
Department of Pediatrics, National Hospital Organization, Nagoya Medical Center, Nagoya, Japan.
Department of Pediatrics, National Cancer Center Hospital, Tokyo, Japan.
Children's Center, Saiseikai Yokohamasi Tobu Hospital, Yokohama, Japan.


Tumor lysis syndrome (TLS), including hyperuricemia, is a frequent serious complication in patients with hematologic malignancies. This study in Japanese patients evaluated the efficacy, safety, and pharmacokinetic profile of rasburicase in pediatric patients with hematologic malignancies. Patients aged <18 years at high risk for TLS, with newly diagnosed hematologic malignancies, were randomized to intravenous rasburicase 0.15 mg/kg/day (n = 15) or 0.20 mg/kg/day (n = 15) for 5 days. Chemotherapy was started 4-24 h after the first rasburicase dose. Response was defined as a reduction in plasma uric acid to < or = 6.5 mg/dL (patients <13 years) or < or = 7.5 mg/dL (patients > or = 13 years) by 48 h after the first administration, lasting until 24 h after the final administration. Response rates were 93.3 and 100% with rasburicase 0.15 and 0.20 mg/kg/day, respectively. Uric acid levels declined rapidly within 4 h of starting rasburicase administration in both groups. Most adverse events were related to the underlying chemotherapy regimens. Two hypersensitivity reactions, including grade 1/2 pruritus, were considered to be related to rasburicase. Rasburicase is effective and well tolerated for the management of hyperuricemia in Japanese pediatric patients at high risk of developing TLS.

[Indexed for MEDLINE]

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