title: Efficacy of rasburicase (recombinant urate oxidase) in the prevention and treatment of malignancy-associated hyperuricemia: an Indian experience.
abstract: BACKGROUND
  Patients with hematological malignancies that are highly proliferative and have high tumor burden are at high risk of developing hyperuricemia and tumor lysis syndrome (TLS), spontaneously and while undergoing chemotherapy.
  
  
  OBJECTIVE
  To assess the safety and efficacy of a new generic formulation of recombinant rasburicase in prevention and treatment of malignancy-associated hyperuricemia.
  
  
  METHODS
  An open-label, multicenter, phase-III study was conducted on 100 eligible patients with high risk for TLS. Rasburicase was administered 0.2 mg/kg intravenously over 30 min, daily, for 4 days. The outcome measures were percentage of reduction in plasma uric acid at 4 h after rasburicase, plasma uric acid area under the curve (AUC)(0-96 h) and incidence of adverse events.
  
  
  RESULTS
  Eighty eight patients completed the study period of 10 days. After rasburicase administration, there was a 75.3 ± 28.5% of reduction in plasma uric acid at 4 h as compared to baseline. The plasma uric acid AUC(0-96 h) was 259.9 ± 215.5 mg/dL h. Safety of rasburicase was assessed on the basis of changes in vitals, hematological, and biochemical parameters from baseline to termination. Except for the plasma uric acid level, there was no significant difference in any of the parameters. Mild to moderate adverse events were reported in 29 patients. Three patients had serious adverse events (SAEs) unrelated to rasburicase.
  
  
  CONCLUSIONS
  These results demonstrated that recombinant rasburicase that is indigenously developed is effective for prevention and management of hyperuricemia in patients who are at high risk of developing TLS.
authors.affiliation: Department of Medical Oncology, Nizam's Institute of Medical Sciences, Hyderabad, India.
authors.forename: R
authors.initials: R
authors.lastname: Digumarti
authors.forename: S
authors.initials: S
authors.lastname: Sinha
authors.forename: S S
authors.initials: SS
authors.lastname: Nirni
authors.forename: S G
authors.initials: SG
authors.lastname: Patil
authors.forename: R M
authors.initials: RM
authors.lastname: Pedapenki
mesh_terms: D000328:Adult; D000368:Aged; D019540:Area Under Curve; D002648:Child; D005260:Female; D006074:Gout Suppressants / Q000627:therapeutic use*; D019337:Hematologic Neoplasms / Q000150:complications*; D006801:Humans; D033461:Hyperuricemia / Q000188:drug therapy* / Q000209:etiology; D007194:India; D008297:Male; D008875:Middle Aged; D012372:ROC Curve; D015275:Tumor Lysis Syndrome / Q000517:prevention & control; D014503:Urate Oxidase / Q000627:therapeutic use*; D014527:Uric Acid / Q000097:blood*; D055815:Young Adult
chemical_list: D006074:Gout Suppressants; C469709:rasburicase; D014527:Uric Acid; D014503:Urate Oxidase