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.
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.
Subject(s)
Adult , Aged , Area Under Curve , Child , Female , Gout Suppressants/therapeutic use , Hematologic Neoplasms/complications , Humans , Hyperuricemia/drug therapy , Hyperuricemia/etiology , India , Male , Middle Aged , ROC Curve , Tumor Lysis Syndrome/prevention & control , Urate Oxidase/therapeutic use , Uric Acid/blood , Young AdultABSTRACT
Background: Acute kidney injury (AKI) continues to have significant mortality and morbidity and the search is on for any novel therapeutic intervention. Case characteristics: Two cases of AKI with elevated SUA (serum uric acid). Intervention: Rasburicase. Outcome: In Case 1 (late preterm male with AKI) rasburicase resulted in a significant reduction of SUA along with improvement in renal parameters. In Case 2 (6 yrs old boy with multi organ failure), rasburicase failed to provide any significant benefit despite fall in SUA.Message: The effect of rasburicase in AKI needs to be studied.