Urate Oxidase (Rasburicase) to Inhibit Graft Versus Host Disease (GVHD) After Myeloablative HLA-Matched Allogeneic Hematopoietic Cell Transplantation (HCT).
Andrew M. BrunnerThomas R. SpitzerYi-Bin A. ChenErin CoughlinSteven L. McAfeeKaren K. BallenEyal C. AttarMartin CaronFrederic I. PrefferBeow Y. YeapBimalangshu R. Dey
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17006 Background: Hyperuricemia, a major component of TLS, has historically been prevented and treated using allopurinol and alkalinization, and recently managed effectively by rasburicase (recombinant urate oxidase) in children and adults at high risk of TLS. We sought to determine the risk factors associated with TLS and develop a risk adapted medical decision model for the prevention and treatment of hyperuricemia in TLS. Methods: TLS risk scoring was performed by an expert panel, based on an odds ratio evaluation of 68 patient characteristics and cancers with known TLS risk. The RAND Appropriateness Method (RAM) (1–3 inappropriate, 4–6 uncertain, 7–9 appropriate) was utilized to investigate the appropriateness of prevention and treatment in 92 different scenarios. All appropriateness ratios were validated using a set of 36 clinical cases. The strategies analyzed included no therapy, hydration (± diuretics [DI]), rasburicase, allopurinol, and allopurinol + alkalinization. Results: Risk factors (±SD) identified included age ≥ 60 years (1.6±0.5), decreased renal function (2.7±1.1), renal tumor infiltration (1.5±0.3), initial cytoreductive therapy (2.5±1.2), acute lymphoblastic leukemia with WBC ≥50x10 9 /L [Burkitt 8.6±5.3; pre-B 4.3±2.4; T-cell 4.6±2.8]; and non-Hodgkin lymphoma with LDH≥ 2x normal [Burkitt 6.6±3.0; lymphoblastic 3.2±2.8; diffuse large B-cell 2.4±1.9]. Hydration (± DI) was considered appropriate while no treatment and allopurinol + alkalinization were inappropriate in all scenarios. For prophylaxis, rasburicase was more appropriate than allopurinol (8.5±0.5 vs 4.9±2.1; p<0.025) in patients with hyperuricemia and/or at high risk of TLS, whereas allopurinol was more appropriate than rasburicase (6.2±1.0 vs 4.9±1.9; p<0.05) in those at low or moderate risk. In patients with TLS and normal urine output and uric acid, allopurinol and rasburicase were considered equally appropriate (5.0±0.9 vs 5.8±0.3). Conclusions: In summary, in addition to hydration (± DI), rasburicase is appropriate for patients at high risk of TLS and/or with hyperuricemia, and allopurinol for those with low risk of TLS and/or normal uric acid concentration. [Table: see text]
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Rasburicase is effective in controlling plasma uric acid in pediatric patients with hematologic malignancies. This study in adults evaluated safety of and compared efficacy of rasburicase alone with rasburicase followed by oral allopurinol and with allopurinol alone in controlling plasma uric acid.Adults with hematologic malignancies at risk for hyperuricemia and tumor lysis syndrome (TLS) were randomly assigned to rasburicase (0.20 mg/kg/d intravenously days 1-5), rasburicase plus allopurinol (rasburicase 0.20 mg/kg/d days 1 to 3 followed by oral allopurinol 300 mg/d days 3 to 5), or allopurinol (300 mg/d orally days 1 to 5). Primary efficacy variable was plasma uric acid response rate defined as percentage of patients achieving or maintaining plasma uric acid ≤ 7.5 mg/dL during days 3 to 7.Ninety-two patients received rasburicase, 92 rasburicase plus allopurinol, and 91 allopurinol. Plasma uric acid response rate was 87% with rasburicase, 78% with rasburicase plus allopurinol, and 66% with allopurinol. It was significantly greater for rasburicase than for allopurinol (P = .001) in the overall study population, in patients at high risk for TLS (89% v 68%; P = .012), and in those with baseline hyperuricemia (90% v 53%; P = .015). Time to plasma uric acid control in hyperuricemic patients was 4 hours for rasburicase, 4 hours for rasburicase plus allopurinol, and 27 hours for allopurinol.In adults with hyperuricemia or at high risk for TLS, rasburicase provided control of plasma uric acid more rapidly than allopurinol. Rasburicase was well tolerated as a single agent and in sequential combination with allopurinol.
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The role of i.v. allopurinol and rasburicase in tumor lysis syndrome (TLS) is described. The current standard management for TLS consists of oral allopurinol in conjunction with i.v. hydration with or without alkalinization. Despite this standard prophylactic regimen, some high-risk patients may still develop urate nephropathy from TLS. Recently, i.v. allopurinol and rasburicase became available for the management of TLS. Available data on i.v. allopurinol indicate that the administration schedule and the adverse-effect profile will be similar to the oral formulation. The primary advantage of i.v. allopurinol is the flexibility of administration for patients who cannot take anything by mouth, since there are no data indicating the superiority of the i.v. to the oral product. Rasburicase is the first agent that will oxidize uric acid to allantoin, a metabolite with 5-10-fold greater solubility than uric acid, and reduces serum uric acid (SUA) levels within four hours of administration. Rasburicase is considerably more expensive than standard management strategies and should be reserved for patients with either renal dysfunction, significant elevations in SUA values, or large tumor burdens. Preliminary evidence indicates that rasburicase offers cost savings in the treatment of TLS and is cost-effective as a strategy for preventing TLS for many cancer patients. Both i.v. allopurinol and rasburicase offer additional flexibility in the management of TLS and may allow for further avoidance of the consequences of inadequate management of this syndrome.
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Objective and background: Tumor lysis syndrome (TLS) is a life-threatening emergency and demands emergency care of effective outcome with minimal or no side effects. The Hypouricemic agents, including Rasburicase, Allopurinol and Febuxostate used for the management of TLS. This study was designed to evaluate the Role of Hypouricemic agents by analyzing TLS development rate, control of uric acid, and Creatinine levels.
Methods: An extensive electronic data search was conducted by using all leading scientific databases. Twenty-six studies were selected to conduct this study, as per the inclusion criteria.
Results: The Odd ratio of TLS development rate was 4.06, 1.24, and 1.49 by Rusbricase, Allopurinol & Febuxostate administration respectively. 95% confidence interval was reported by selected studies against TLS development rate, Uric acid, and Creatinine levels by administrating Rusbricase, Allopurinol & Febuxostate.
Conclusion: All Hypouricemic agents, including Rasburicase, Allopurinol and Febuxostate, are effective to manage Tumor lysis Syndrome. However, a suitable and most effective intervention dose needs to identify with better efficacy and minimal side effects both in Adults and Children.
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Journal Article Role of i.v. allopurinol and rasburicase in tumor lysis syndrome Get access American Journal of Health-System Pharmacy, Volume 60, Issue 21, 1 November 2003, Pages 2223–2224, https://doi.org/10.1093/ajhp/60.21.2223 Published: 01 November 2003
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