Untitled
Loading...
Date
2014-04
Journal Title
Journal ISSN
Volume Title
Publisher
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. AIM: To assess the safety
and efficacy of a new generic formulation of recombinant rasburicase in prevention and treatment of malignancy‑associated hyperuricemia.
MATERIALS AND 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 AUC0-96 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.
Description
Keywords
Hyperuricemia, rasburicase, tumor lysis syndrome, uric acid, urate oxidase
Citation
Digumarti R, Sinha S, Nirni S S, Patil S G, Pedapenki R M. Efficacy of rasburicase (recombinant urate oxidase) in the prevention and treatment of malignancy-associated hyperuricemia: An Indian experience. Indian Journal of Cancer. 2014 Apr-Jun; 51(2): 180-183.