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&NA;. "Rasburicase." Reactions Weekly &NA;, no. 1186 (January 2008): 32. http://dx.doi.org/10.2165/00128415-200811860-00101.
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&NA;. "Rasburicase." Reactions Weekly &NA;, no. 1140 (February 2007): 19. http://dx.doi.org/10.2165/00128415-200711400-00067.
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&NA;. "Rasburicase." Reactions Weekly &NA;, no. 1367 (September 2011): 32. http://dx.doi.org/10.2165/00128415-201113670-00113.
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&NA;. "Rasburicase." Reactions Weekly &NA;, no. 1371 (October 2011): 33. http://dx.doi.org/10.2165/00128415-201113710-00123.
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&NA;. "Rasburicase." Reactions Weekly &NA;, no. 1209 (July 2008): 26–27. http://dx.doi.org/10.2165/00128415-200812090-00084.
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&NA;. "Rasburicase." Reactions Weekly &NA;, no. 1087 (February 2006): 24. http://dx.doi.org/10.2165/00128415-200610870-00081.
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Oldfield, Vicki, and Caroline M. Perry. "Rasburicase." Drugs 66, no. 4 (2006): 529–45. http://dx.doi.org/10.2165/00003495-200666040-00008.
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&NA;. "Rasburicase." Reactions Weekly &NA;, no. 1284 (January 2010): 36–37. http://dx.doi.org/10.2165/00128415-201012840-00122.
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&NA;. "Rasburicase." Reactions Weekly &NA;, no. 1307 (June 2010): 39. http://dx.doi.org/10.2165/00128415-201013070-00126.
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&NA;. "Rasburicase." Reactions Weekly &NA;, no. 1024 (October 2004): 13. http://dx.doi.org/10.2165/00128415-200410240-00038.
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Easton, Jane, Stuart Noble, and Blair Jarvis. "Rasburicase." Paediatric Drugs 3, no. 6 (2001): 433–37. http://dx.doi.org/10.2165/00128072-200103060-00004.
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Pui, Ching-Hon. "Rasburicase." Paediatric Drugs 3, no. 6 (2001): 438–39. http://dx.doi.org/10.2165/00128072-200103060-00005.
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Goldman, Stan. "Rasburicase." Paediatric Drugs 3, no. 6 (2001): 438–39. http://dx.doi.org/10.2165/00128072-200103060-00006.
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Cada, Dennis J., Terri Levien, and Danial E. Baker. "Rasburicase." Hospital Pharmacy 38, no. 1 (January 2003): 50–57. http://dx.doi.org/10.1177/001857870303800107.
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Each month, subscribers to The Formulary Monograph Service receive five to six well-documented monographs on drugs that are newly released or are in late Phase III trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. The monographs are published in printed form and on diskettes that allow customization. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800–322–4349. The January 2003 monograph topics are ezetimibe, enfurvitide, aripiprazole, atomoxetine, and amoxicillin/clavulanate potassium extended-release tablets. The DUE is on ezetimibe.
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&NA;. "Rasburicase." Reactions Weekly &NA;, no. 1426 (November 2012): 37. http://dx.doi.org/10.2165/00128415-201214260-00132.
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Yim, Barbara, Anne Navaleza, Augustin Haidau, Shylendra Sreenivasappa, Mohammed A. Kassem, Bety C. Ciobanu, Tareq Braik, et al. "Single 4.5mg Dose of Rasburicase for Tumor Lysis Syndrome In Adults." Blood 116, no. 21 (November 19, 2010): 1779. http://dx.doi.org/10.1182/blood.v116.21.1779.1779.
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Abstract Abstract 1779 Introduction: Tumor Lysis Syndrome (TLS) is an oncologic emergency that leads to a host of metabolic disturbances which can ultimately result in acute renal failure and death. Currently rasburicase, Elitek™, is FDA approved for the treatment of TLS in patients with leukemia, lymphoma, and solid tumor malignancies which have risk factors for TLS. The approved adult dose is 0.2mg/kg/day over 30 minutes for up to 5 days. Chemotherapy should be initiated within 24 hours of rasburicase administration. Since rasburicase's introduction to the market, various studies have examined single dose use (3mg and 6mg) in the adult population, trying to resolve the dilemma of determining a dosing regimen for adults that is as effective as the FDA approved dosing regimen, while minimizing cost. This study was aimed at determining if a single 4.5mg dose of rasburicase would be adequate in reducing uric acid levels (UAL) as compared to the FDA approved conventional weight based approach; it also sought to determine the cost-effectiveness of this approach. Method: This is a retrospective study of the John H. Stroger Jr. Hospital of Cook County (JHS) patients who were administered a single dose of 4.5 mg rasburicase for TLS from 12/2007 to 06/2010. We included patients ≥ 18 years old, with a hematologic malignancy and on chemotherapy or about to start receiving chemotherapy within 24 hours of rasburicase administration. Patients with low risk for TLS or an indication other than prevention and management of TLS were excluded. Result: Demographics: Characteristics: Responders are defined as patients that achieved more than 50% reduction in the UAL at 24 hours, 48 hours or 96 hours or a decrease of UAL to normal levels. Two patients required a second dose to achieve response. The non-responders did not receive any additional doses for unclear reasons. No adverse events were noted. Conclusion: This retrospective study provides evidence that a single 4.5mg dose of rasburicase effectively reduced plasma UAL to within normal limits. In addition, decrease in plasma UAL was observed within 24 hours after administration. No effect on electrolytes and serum creatinine was noted. The cost-effectiveness of a single 4.5mg dose of rasburicase was evaluated based on dose and drug cost. The potential cost saving was substantial when compared with the FDA approved dose. In our opinion, this study validates the use of a single dose of 4.5mg rasburicase in the treatment and prophylaxis of TLS. This dose can be considered as a possible alternative to the FDA approved adult dosing regimen. Disclosures: No relevant conflicts of interest to declare.
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Cortes, Jorge, Joseph O. Moore, Richard T. Maziarz, Meir Wetzler, Michael Craig, Jeffrey Matous, Selina Luger, et al. "Control of Plasma Uric Acid in Adults at Risk for Tumor Lysis Syndrome: Efficacy and Safety of Rasburicase Alone and Rasburicase Followed by Allopurinol Compared With Allopurinol Alone—Results of a Multicenter Phase III Study." Journal of Clinical Oncology 28, no. 27 (September 20, 2010): 4207–13. http://dx.doi.org/10.1200/jco.2009.26.8896.
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Purpose 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. Patients and Methods 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. Results 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. Conclusion 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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Eng, Stephen, Chung-Shien Lee, Seungjun Ahn, and Amy Sharma. "A retrospective analysis of tumor lysis syndrome management in a quaternary care hospital." Journal of Oncology Pharmacy Practice 26, no. 2 (May 14, 2019): 338–44. http://dx.doi.org/10.1177/1078155219846949.
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Purpose Due to an increased use of rasburicase, the study’s purpose was to evaluate both the management of tumor lysis syndrome and the utilization of rasburicase in the hospital system. Additionally, the efficacy of flat dose rasburicase in lowering uric acid levels was evaluated. Based on the study’s findings, the investigators will evaluate the usefulness of implementing a tumor lysis syndrome order set. Methods This study evaluated patients from January 2013 through December 2016 for the rasburicase dose and the tumor lysis syndrome therapy administered. Results Overall, 251 patients were included: prophylactic rasburicase group (n = 125) vs. treatment rasburicase group (n = 126) and of rasburicase 3 mg (R3) group (n = 168) vs. 6 mg (R6) group (n = 83). The prophylactic rasburicase vs. treatment rasburicase group had a significantly lower rate of receiving a xanthine oxidase inhibitor (48.0% vs. 64.3%, p = 0.009), a phosphate binder (6.4% vs. 17.5%, p = 0.007) and an additional dose of rasburicase (20.8% vs. 41.3%, p = 0.001). Intravenous hydration was neither significantly different between the rasburicase groups (p = 0.399) nor between the two rasburicase dosing groups (p = 0.874). Between the rasburicase dosing groups, there was no significant difference in the rate of receiving a xanthine oxidase inhibitor (p = 0.521) or a phosphate binder (p = 0.390). R6 patients had a significantly greater reduction in uric acid change compared to R3 patients (median = −7.9 (−10.1, −5.5) vs. −4.3 (−6.0, −2.7), p < 0.0001). There was no significant difference in uric acid change between the prophylactic rasburicase and treatment rasburicase groups (p = 0.875). Conclusion The study’s findings justified the need to implement a tumor lysis syndrome order set. In the study population, utilizing a flat dosing method was effective for hyperuricemia.
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Kassem, Nancy, Halima El Omri, Mohamed Yassin, and Shereen Elazzazy. "BPI19-016: Evaluation of the Use of a Single Dose Rasburicase in Prophylaxis and Management of Tumor Lysis Syndrome (TLS) Among Cancer Patients in Qatar." Journal of the National Comprehensive Cancer Network 17, no. 3.5 (March 8, 2019): BPI19–016. http://dx.doi.org/10.6004/jnccn.2018.7147.
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Introduction: Rasburicase is a urate oxidase enzyme used for prophylaxis and treatment of hyperuricemia associated with TLS. The recommended dose of rasburicase is 0.2 mg/kg/day for 5 days; however, recent studies have demonstrated the effectiveness of a single rasburicase dose in prophylaxis and management of hyperuricemia associated with TLS. Our institution’s TLS guideline was updated to recommend the use of a single rasburicase dose (0.2 mg/kg). The primary objective of this study was to assess the efficacy of a single rasburicase dose in controlling uric acid (UA); the secondary objective was to evaluate the impact of the institutional TLS guidelines update on consumption and cost of rasburicase. Methods: This is a single center retrospective cohort study including all patients who received rasburicase from August 2012 to March 2016 at the National Center for Cancer Care and Research (NCCCR) in Qatar. Patients were divided into 2 groups based on the prescribed number of rasburicase doses (single dose vs multiple doses). Collected data included patients’ diagnosis, laboratory parameters rasburicase dose, duration, and number of dispensed vials. UA levels within 24 hours and on day 5 of initial rasburicase dose were evaluated. Risk stratification was determined according to institutional guidelines based on disease, white blood cell count, lactate dehydrogenase level, renal function, and UA level. Results: A total of 103 patients who received rasburicase were evaluated retrospectively; rasburicase was prescribed as single dose for 65 patients (63%) and multiple doses for 38 patients (37%). The majority of patients who received rasburicase as single or multiple doses were at high risk of developing TLS, representing 68% and 84%, respectively. Baseline mean UA levels were similar in both groups: 5.4±2.9 mg/dL vs 4.7±3.2 mg/L respectively (P=.7). Normal or undetectable UA levels were observed within 24 hours in 98% of patients in the single dose group and 100% of patients in the multiple doses group. All patients in both groups had normal UA on day 5 of rasburicase with relatively similar UA levels: 1.5±1.2 mg/dL vs 0.8±1 mg/dL (P=.18). Rasburicase consumption and cost were reduced by 42.5% after the guidelines update. Conclusion: The single rasburicase dose demonstrated efficacy in controlling serum UA levels. Updating the institutional TLS guidelines had a significant impact on rasburicase consumption and led to significant cost reduction.
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Wang, Alice C., Deborah McCue, Farhad Ravandi, Gautam Borthakur, Deborah A. Thomas, Stefan Faderl, William G. Wierda, and Jorge E. Cortes. "Outcomes Of Repeated Administration Of Rasburicase In Recurrent Cycles For Patients With Leukemia." Blood 122, no. 21 (November 15, 2013): 3888. http://dx.doi.org/10.1182/blood.v122.21.3888.3888.
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Abstract Introduction Rasburicase, a recombinant urate oxidase, is effective at reducing plasma uric acid levels in patients who are at risk for tumor lysis syndrome. Since rasburicase is produced by a genetically modified Saccharomyces cerevisiae strain using the cDNA from an Aspergillus flavus strain, it may cause anti-rasburicase antibodies to develop. Anti-rasburicase antibodies pose a major safety and efficacy concern in that they can contribute to hypersensitivity reaction and/or the loss of uricolytic activity in patients who receive more than one cycle of rasburicase. We sought to evaluate the efficacy and rate of adverse reactions in those patients who received more than one cycle of rasburicase. Methods Pharmacy records were used to identify patients treated on the adult leukemia service who received more than one cycle of rasburicase therapy during the time period of January 2003 to May 2013. To be classified as a new cycle, a break in rasburicase therapy of at least 21 days needed to occur. Electronic medical records were used to document demographic, laboratory and clinical course information for the first 3 cycles of rasburicase administered. Uric acid levels as well as adverse events possibly attributable to rasburicase were collected for up to 3 days following the first dose of a cycle. Tumor lysis risk was determined using the method described by Cairo, et al (Cairo MS, et al on behalf of the TLS expert panel. Br J Haematol 2010; 149: 578-586.). Results Two hundred and forty-two patients were identified that received at least 2 cycles of rasburicase therapy. Fifty-two of the patients received a third cycle of rasburicase therapy. Median patient age was 61 years for those patients receiving a second cycle and 56 years for those receiving a third cycle. The majority of the patients had AML (45%), ALL (20%) or CLL (16%). The second and third cycles of rasburicase were administered a median of 86.5 (range: 22-3736) and 52.5 (range: 21-690) days, respectively, from the previous cycle. The median uric acid level measured the day following the first dose of rasburicase therapy was below the laboratory normal range (2.6 – 7.1 mg/dL) on all cycles: 1.5 mg/dL on Cycle 1, 2.4 mg/dL on Cycle 2 and 2.15 mg/dL on Cycle 3. Seventeen patients (7%) experienced adverse events that could possibly be attributed to rasburicase therapy, including shortness of breath, chills, nausea, itching and rash. In 11 of the 17 patients, concomitantly administered agents, such as monoclonal antibodies, were more likely to be causative of the adverse events based on temporal or clinical findings. Only 1 patient (0.4%), who experienced shortness of breath and rash approximately 30 minutes following the rasburicase dose, had symptoms that would be consistent with a hypersensitivity reaction due to rasburicase. Despite the reaction, the patient’s uric acid level following rasburicase decreased into the normal range. Conclusions This study indicates that, in our population of adult patients with leukemia, subsequent cycles of rasburicase therapy remain safe and effective. Rasburicase was able to lower baseline uric acid levels to below the normal range following the first dose. Additionally, only 1 patient experienced a hypersensitivity reaction that was clearly attributable to rasburicase administration. Prospective studies evaluating antibody production in those patients who develop hypersensitivity reactions, or fail to have a clinical response, to rasburicase therapy would help validate our observations. Disclosures: Off Label Use: Rasburicase is not approved for the administration of repeated courses of therapy. Ravandi:Sanofi: Research Funding. Cortes:Sanofi: Research Funding.
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Xu, Hui, Frederick Mills, and Edward E. Max. "Intravenous rasburicase-induced immune tolerance is associated with depletion of specific lymphocytes and up-regulation of regulatory T cells." Journal of Immunology 196, no. 1_Supplement (May 1, 2016): 125.17. http://dx.doi.org/10.4049/jimmunol.196.supp.125.17.
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Abstract Therapeutic proteins can be potent agents for treating serious diseases, but in many patients these proteins provoke antibody responses that blunt therapeutic efficacy. Intravenous administration of high doses of some proteins induces immune tolerance, but the mechanisms behind this effect are poorly understood. As a model to study tolerance induction in mice, we used Rasburicase, a commercial recombinant uricase used for treatment of hyperuricemia. Intraperitoneal (i.p.) injection of Rasburicase without or with alum provoked a clear anti-Rasburicase antibody response, but intravenous (i.v.) injection did not. The lack of response to i.v. Rasburicase was apparently due to active immune suppression, since i.v.-treated mice showed blunted antibody and reduced T cell responses to subsequent i.p. injections of Rasburicase. This blunted response was associated with a decrease in Rasburicase-specific B cells and T cell proliferation, and an increase in proportion of CD4+ FoxP3+ regulatory T cells (Treg). We examined the number of lymphocytes in peripheral blood after Rasburicase i.v. injection. Intravenous injection of rasburicase temporary reduced numbers of B cells and T cells, but robustly depleted Rasburicase-specific B cells in blood. Further results showed that rasburicase i.v. injection decreased the number of lymphocytes by inducing apoptosis of B cells and activated T cells. Thus, our data suggests that Rasburicase i.v. injection-induced apoptosis and depletion of lymphocytes and up-regulation of Treg cells play important roles in the intravenous therapeutic protein-induced immune tolerance.
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McBride, Ali, Melissa Hagan, Mei Xue, and Robert E. Smith. "Healthcare Resource Utilization with Rasburicase in the Management of Patients with Tumor Lysis in the Outpatient Setting: Results from a Community Oncology Cohort." Blood 134, Supplement_1 (November 13, 2019): 3401. http://dx.doi.org/10.1182/blood-2019-125922.
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BACKGROUND and OBJECTIVE: Tumor lysis syndrome (TLS), a potentially fatal oncologic complication, can have a significant clinical and economic impact to patients and the healthcare system. The aim of this analysis was to examine healthcare resource utilization in patients treated with rasburicase for the management of tumor lysis in the outpatient versus inpatient setting. METHODS: Adult patients were selected from the Integra Connect Database (IC) if they were treated with rasburicase between January 1, 2017 and March 31, 2019. The IC database comprises clinical and financial records for more than 750,000 community oncology patients, including 25,000 active Oncology Care Model participants representing approximately 20% of the unique beneficiaries in this Medicare model. Patients treated in the outpatient setting were divided into 3 groups: Primary Prophylaxis- treatment with rasburicase administered days 0-2 of chemotherapy (Group A), Early Reactive- rasburicase administered days 3-5 of chemotherapy (Group B), and Late Reactive- rasburicase administered after day 5 of chemotherapy (Group C). Inpatients were divided into 2 groups: Inpatient TLS Treatment- patients admitted and treated for TLS with rasburicase and who had not received rasburicase as part of their outpatient chemotherapy regimen (Group D) and Inpatient Chemotherapy- patients admitted for chemotherapy who were given rasburicase (Group E). Demographic, clinical characteristics including tumor types, lab values, and dose information were collected. Total cost of rasburicase was calculated as mean drug cost per patient. All variables were summarized descriptively as mean (SD), median (min and max) or counts (percentages). RESULTS: A total of 265 patients treated with rasburicase were included in the analysis. Of those, 189 patients received rasburicase in the outpatient setting vs 76 in the inpatient setting. None of the 189 patients in Groups A, B, and C who received outpatient rasburicase required admission due to TLS. Patient demographic and clinical characteristics, as well as rasburicase utilization, were similar between cohorts (Table 1 and Table 2). Our results show that while 54% of patients in Groups B, C, and D were initially treated with allopurinol, these patients were switched to rasburicase, indicating failure of allopurinol alone. The total cost of rasburicase trended lower in the outpatient vs inpatient setting ($9,287 vs $11,959). However, a more appropriate comparator to this cost is the published data for charges incurred for inpatient treatment of TLS, shown to be $151,9171 CONCLUSIONS: TLS continues to impact patients with diagnoses and chemotherapy regimens at intermediate and high risk for development of this syndrome. This study demonstrates that allopurinol is frequently inadequate and replacement with rasburicase is needed. We found rasburicase to be effective from both a clinical and a cost perspective in preventing TLS-related hospitalization. While rasburicase is most efficiently employed as primary prevention, close monitoring of patients allows effective reactive utilization evidenced by none of the outpatients in this study who received rasburicase were admitted for TLS. This study highlights the opportunity for greater utilization of rasburicase in the outpatient setting, as a means to lower the total cost of care. 1. Pathak et al. Blood. 2017; 130:3390 Disclosures McBride: teva: Consultancy; Sandoz: Consultancy; Sanofi Genzyme: Consultancy.
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Eaddy, M., K. O’Day, K. M. Tangirala, and B. Seal. "The economic implications of rasburicase treatment in adult tumor lysis syndrome patients." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): e17503-e17503. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e17503.
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e17503 Background: Rasburicase is a recombinant urate-oxidase enzyme used to reduce high levels of plasma uric acid (UA) resulting from tumor lysis syndrome (TLS). Rasburicase reduces UA levels within 4 hours of administration, minimizing risk of serious complications from TLS. Treatment pattern analyses indicate rasburicase is often used in combination with allopurinol; however, no studies have evaluated clinical and economic consequences of this pattern of care. The purpose of the study was to compare hospitalization costs, length of stay (LOS), and duration of critical care in patients receiving rasburicase with or without allopurinol. Methods: Patients in the Premier hospital database administered rasburicase or combination therapy within 2 days of hospital admission were eligible for study inclusion. Patients were excluded if they were <18 years of age or received hemodialysis on admission. Patients were propensity score matched to rasburicase patients based on gender, race, hospital type, provider type, payer type, admission source, use of electrolyte modification therapy, critical care admission, and comorbid diagnoses. Differences in health care costs, LOS, and duration of subsequent critical care were assessed using exponentially distributed generalized linear models with a log link function. Projection weights are used to produce national projected patient counts. Results: There were 280 rasburicase and 310 combination patients matched in the analysis. Mean age of the sample was 65.2, with 31% being female. There were no statistical differences in matched covariates across the cohorts. Rasburicase patients incurred an average total cost of $39,474 per hospitalization compared to $52,047 for combination patients (p = 0.0029). Rasburicase patients also had a lower LOS (10.5 days) compared to combination therapy (16.4 days, p < 0.0001). Duration of critical care was similar in both cohorts (rasburicase = 1.4 days vs 1.8 days, p = 0.1222). Conclusions: Combination therapy of rasburicase and allopurinol resulted in higher total hospitalization costs and longer LOS compared to rasburicase monotherapy. [Table: see text]
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Kobayashi, Shunsuke, Takeo Yasu, and Manabu Akazawa. "Survey of Anaphylaxis during Rasburicase Re-Administration in Patients with Hematological Malignancies Using a Japanese Claims Database." Current Oncology 29, no. 12 (December 14, 2022): 9826–32. http://dx.doi.org/10.3390/curroncol29120772.
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Management of tumor lysis syndrome (TLS) associated with cancer chemotherapy for malignant tumors is important because of its potentially fatal course. The use of rasburicase, a recombinant urate oxidase, is recommended for TLS; however, because rasburicase is an enzymatic drug, one should be cautious of anaphylaxis during administration. Using claims data in Japan, we investigated the rate of rasburicase re-administration and the occurrence of anaphylaxis during re-administration in patients with hematopoietic malignancies in a multicenter setting. Re-administration of rasburicase was defined as administration after an interval of 21 days from the first dose. Of 373 patients, 18 were re-administered rasburicase (re-administration rate: 4.8%). No patient developed anaphylaxis. The median number of days from the first to the last dose of rasburicase was 256.5 days (interquartile range: 138.8–455.8 days). The median daily dose was 7.5 mg (4.5–11.3 mg), and the median total dose was 33.8 mg (19.1–64.1 mg). This claims database analysis revealed that the re-administration rate of rasburicase was low in Japanese patients with hematopoietic malignancies, suggesting that rasburicase was being used appropriately, and that associated anaphylaxis was not observed.
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Generali, Joyce, and Dennis J. Cada. "Rasburicase: Gout." Hospital Pharmacy 43, no. 3 (March 2008): 194–98. http://dx.doi.org/10.1310/hpj4303-194.
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Boutin, Alyssa, Alison Blackman, David M. O’Sullivan, and Nicholas Forcello. "The value of fixed rasburicase dosing versus weight-based dosing in the treatment and prevention of tumor lysis syndrome." Journal of Oncology Pharmacy Practice 25, no. 3 (January 10, 2018): 577–83. http://dx.doi.org/10.1177/1078155217752075.
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Background Rasburicase is a recombinant urate oxidase enzyme used for the treatment and prevention of tumor lysis syndrome. Our objective was to assess the efficacy of indication-based, low-dose rasburicase administration compared to the Food and Drug Administration-approved weight-based dosing. Methods This was a retrospective cohort study utilizing data from a tertiary medical center including patients admitted from 2012 to 2016, who received at least one dose of rasburicase. The primary outcome was achieving a uric acid level less than 7.5 mg/dl after a single dose of rasburicase in the preprotocol (Food and Drug Administration-approved weight-based dosing) and postprotocol (indication-based, low-dose) groups. Secondary outcomes included the change in uric acid levels between the pre- and postprotocol groups, adherence to the new institutional protocol, need for repeat rasburicase doses, and a cost analysis. Results Sixty-four patients received at least one dose of rasburicase between 1 January 2012 and 1 December 2016. Twenty-seven (79.4%) doses in the preprotocol group and 28 (82.4%) doses in the postprotocol group successfully achieved a uric acid level less than 7.5 mg/dl after a single dose of rasburicase (p=1.000). The average total monthly cost of rasburicase was reduced by 59.9% after adoption of the new protocol. Conclusions Indication-based, low-dose rasburicase displayed significantly more value when compared to weight-based dosing as shown by achieving cost savings without compromising clinical efficacy.
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Allen, Katherine C., Amanda H. Champlain, Jonathan Cotliar, Steven M. Belknap, Dennis P. West, Jayesh Mehta, and Steven Trifilio. "Anaphylaxis Associated with Administration of Repeated Courses of Rasburicase: A Research On Adverse Drug Events and Reports (RADAR) Project." Blood 120, no. 21 (November 16, 2012): 1351. http://dx.doi.org/10.1182/blood.v120.21.1351.1351.
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Abstract Abstract 1351 Purpose Rasburicase (recombinant urate oxidase) is used to rapidly metabolize uric acid in patients with hyperuricemia. Rasburicase is considered immunogenic given that it is produced by a genetically modified Saccharomyces cerevisiae. Rasburicase labeling indicates that anaphylaxis rarely occurs (<1% of patients) after a single course of therapy, yet has been shown to elicit an antibody response in 64% of healthy volunteers within one to six weeks after the initial course, and with persistent antibodies for well over one year. Currently there are no data available on the incidence of anaphylaxis in patients receiving a subsequent rasburicase course after an interval of at least three weeks. We sought to determine the incidence of anaphylaxis after repeated courses of rasburicase during subsequent episodes of hyperuricemia. Methods Electronic medical records were used to identify patients with hematological malignancies who were treated with rasburicase for separate episodes of hyperuricemia. All evaluable patients received subsequent identical low doses of rasburicase (3mg or 6mg) for separate hyperuricemia episodes with at least 21 day intervals. Anaphylaxis included diagnostic coding and documentation in the record of angioedema and airway compromise. Results Ninety-seven patients met criteria for inclusion in the study. No patients experienced anaphylaxis during the first treatment course of rasburicase, however six patients (6.2%) experienced anaphylaxis after a subsequent course (p=0.03), three of which required intubation, and two resulted in cardiac arrest with one death (see Table 1). The subsequent course of rasburicase associated with anaphylaxis was administered an average of 8.5 months after the first course and anaphylaxis occurred, on average, 93 minutes after rasburicase was administered. Notably, two of the six patients met laboratory criteria for tumor lysis syndrome at the time of the anaphylactic reaction. There was no evidence of hemolysis in the six patients, and they were not tested for G6PD deficiency or methemoglobinemia. The calculated number needed to harm after administration of a subsequent course of rasburicase is 17 (95% CI 9.1 – 71.9). Conclusion This study indicates that, in our population, the incidence of anaphylaxis after the administration of subsequent treatment courses of rasburicase for hyperuricemic episodes may be greater than that described in the FDA-approved package insert for initial treatment courses. Caution is advised given the serious nature of the events (i.e. anaphylaxis, cardiac arrest, death) when administering repeated courses of rasburicase, and as with other agents that may predispose to immediate hypersensitivity reactions, premedication with antihistamines and corticosteroids should be considered. Disclosures: Off Label Use: Rasburicase is not approved for the administration of repeated courses of therapy.
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O'Day, K., M. Eaddy, B. Seal, and K. M. Tangirala. "The economic implications of rasburicase treatment in pediatric tumor lysis syndrome patients." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): 10050. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.10050.
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10050 Background: Rasburicase is a recombinant urate-oxidase enzyme used to reduce high levels of plasma uric acid (UA) resulting from tumor lysis syndrome (TLS) in pediatric patients. Rasburicase reduces UA levels within 4 hours of administration, minimizing risk of serious complications from TLS. Although the efficacy of rasburicase has been demonstrated in clinical trials, there are few studies that have evaluated the economic implications of using rasburicase rather than allopurinol, the current standard of care. Methods: Pediatric patients administered rasburicase or allopurinol within 2 days of hospital admission were eligible for study inclusion. Patients were excluded if they were ≥ 18 years of age or received hemodialysis on admission. Patients receiving allopurinol or combination therapy were then propensity score matched to rasburicase patients based on gender, race, hospital type, provider type, payer type, admission source, use of electrolyte modification therapy, critical care admission, and comorbid diagnoses. Differences in healthcare costs, length of stay, and duration of subsequent critical care were assessed using gamma distributed generalized linear models with a log link function. Results: There were 63 allopurinol and 63 rasburicase patients matched in the analysis. The mean age of the sample was 7.4 years, with 27% being female. There were no statistical differences in matched covariates across the cohorts. Rasburicase patients incurred an average of $30,470 per hospitalization compared to $35,165 for allopurinol patients (p = 0.427). Mean length of stay was not statistically different across the cohorts, averaging 14 days. Duration of critical care was significantly lower for rasburicase (1.4 days) when compared to allopurinol (2.5 days, p = 0.0001). Conclusions: Treatment with rasburicase is associated with similar costs and a lower duration of critical care when compared to allopurinol therapy. [Table: see text]
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Patel, Komal K., Timothy J. Brown, Arjun Gupta, Taylor Roberts, Eileen Marley, Hsiao C. Li, and Navid Sadeghi. "Decreasing Inappropriate Use of Rasburicase to Promote Cost-Effective Care." Journal of Oncology Practice 15, no. 2 (February 2019): e178-e186. http://dx.doi.org/10.1200/jop.18.00528.
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BACKGROUND: Rasburicase is a recommended treatment of tumor lysis syndrome and patients at high-risk for developing tumor lysis syndrome. Unfortunately, it is expensive, and unnecessary use raises costs of care. METHODS: Plan, Do, Study, Act methodology was used to decrease the inappropriate use of rasburicase. In the Plan phase, a multidisciplinary quality improvement team reviewed the rasburicase ordering process and its prescription patterns at Parkland Health and Hospital System between October 2015 and September 2017 to determine appropriate interventions for improvement. In the Do phase, interventions were deployed to improve rasburicase prescriptions. In the Study phase, the team reviewed the rasburicase orders and appropriateness from February 2018 to October 2018. During the Act phase, the interventions were found to be successful, and the process changes were solidified. RESULTS: At baseline, 65 doses of rasburicase were administered during the 2-year baseline period, 21 of these (32.3%) were inappropriate. Review of the ordering process identified pitfalls: one-click ready-to-sign order, fixed default dose, no hard-stop alert requiring physicians to review and confirm appropriate indications, and lack of secondary pharmacy review. We aimed to reduce the percentage of inappropriate rasburicase orders from a baseline of 32.3% to 10% over 3 months. In February 2018, we implemented the interventions, which resulted in reduction in inappropriate rasburicase use, with only a single inappropriate order placed in 7 months postintervention. CONCLUSION: A multidisciplinary approach and classic quality improvement methodology enabled us to reduce inappropriate rasburicase use. Straightforward electronic medical record interventions and secondary pharmacy review are effective in addressing overuse.
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Radtchenko, Janna, Daniel Lyons, Yvonne Barnes, Scott Milligan, and Edward Drea. "Clinical Practice Utilization and Outcomes with Rasburicase Vs Allopurinol for Patients at High Risk of Tumor Lysis Syndrome." Blood 134, Supplement_1 (November 13, 2019): 2203. http://dx.doi.org/10.1182/blood-2019-124319.
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Introduction The efficacy of rasburicase vs allopurinol for the prevention of hyperuricemia (HU) of tumor lysis syndrome (TLS) has been demonstrated in clinical trials, yet studies evaluating these therapies in real-world clinical practice are lacking. Here, we evaluate the real-world use and clinical impact of rasburicase and allopurinol for the prevention of chemotherapy-induced HU. Methods Data were collected from a proprietary aggregated Electronic Medical Records database containing data from 21 healthcare organizations and 26 million patients in the US. Inclusion criteria included patients at high risk (HR) of TLS (Table 1) and diagnosed with acute lymphocytic leukemia, acute myeloid leukemia, Burkitt's Lymphoma, chronic lymphocytic leukemia, or diffuse large B-cell lymphoma, and receiving chemotherapy between 01/01/2017 and 06/30/2018. Baseline measures were those within 6 months but closest to and before the start of chemotherapy. Patients were followed until death or 6 months from the start of chemotherapy. Statistical analyses included Student's t-test for continuous variables and Chi-squared, Fisher's exact, or McNemar's test for categorical variables. Multivariate analyses were conducted to assess association of variables and to generate scores for propensity score matching (PSM). Results Of the patients who qualified for the study, 74% (991) received allopurinol, 7% (92 patients) rasburicase, and 19% (248) did not receive a urate-lowering therapy. Patients receiving rasburicase were more likely to be male, with pre-existing TLS at chemotherapy drug initiation, and previously treated with rasburicase or both urate-lowering therapies. The TLS risk population receiving rasburicase presented with higher mean baseline uric acid level (9.0 mg/dL) compared with patients receiving allopurinol (6.9 mg/dL), and over half had baseline uric acid levels >7.5 mg/dL (56% vs 35% for allopurinol). Multivariate analysis further indicated that a greater fraction of patients receiving rasburicase had renal impairment (glomerular filtration rate [GFR] <60 mL/min at baseline) compared with the population receiving allopurinol (Table 1). Treatment with rasburicase significantly decreased levels of uric acid and calcium and improved phosphate levels from baseline to post-treatment. These changes were significantly greater than observed in patients receiving allopurinol. In contrast, patients receiving allopurinol recorded improved GFR whereas changes in the rasburicase-treated population did not reach significance (Table 2). Follow-up varied for these treatment groups: 49% of patients at HR of TLS receiving rasburicase died within 6 months of the start of chemotherapy compared with 13% of allopurinol patients (p<0.001). PSM yielded small matched samples no longer representative of the severity of the condition of the rasburicase patients. No significant differences in rasburicase vs allopurinol efficacy were detected in these smaller samples. Conclusions Patients at HR of TLS and receiving rasburicase had higher uric acid levels at baseline, more renal impairment, and were more likely to have experienced TLS previously compared with those receiving allopurinol. Both rasburicase and allopurinol significantly decreased levels of uric acid post-treatment though the mean decrease was significantly higher in rasburicase patients. These data support previous clinical findings that rasburicase is highly effective in reducing uric acid, though observed use in the real-world setting is restricted to patients with increased sickness. These findings support the need for continued research of the outcomes associated with early recognition and prophylaxis with rasburicase for patients with moderate risk and HR features for HU of TLS. Disclosures Radtchenko: Sanofi: Research Funding. Lyons:Sanofi: Employment. Barnes:Sanofi: Employment. Milligan:Trio Health: Employment; AbbVie: Research Funding; Amgen: Research Funding; Gilead: Research Funding; Merck: Research Funding; Sanofi: Research Funding; Viiv: Research Funding. Drea:Sanofi-Genzyme: Employment.
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Nauffal, Mary, Robert Redd, Jian Ni, Richard M. Stone, Daniel J. DeAngelo, and Anne M. McDonnell. "Single 6-mg dose of rasburicase: The experience in a large academic medical center." Journal of Oncology Pharmacy Practice 25, no. 6 (August 15, 2018): 1349–56. http://dx.doi.org/10.1177/1078155218791333.
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Background Tumor lysis syndrome is an oncologic emergency due to the release of tumor cell contents, leading to metabolic derangements. Rasburicase, a recombinant urate oxidase, catabolizes uric acid. At our institution, we administer a single 6-mg dose of rasburicase to patients who are at risk for tumor lysis syndrome. We aimed to assess the efficacy of single 6-mg dose of rasburicase and explore risk factors associated with rasburicase failure. Methods We report results in 92 adult patients who had a baseline uric acid greater than 7.5 mg/dL and received a single 6-mg dose of rasburicase for the management of tumor lysis syndrome. Responders were defined as those whose uric acid was less than or equal to 7.5 mg/dL within 24–36 h of rasburicase administration. The primary end point was response based on uric acid level. Secondary end points included response to rasburicase in association with lactate dehydrogenase, serum creatinine, calcium, phosphorus, blood pH, and oncologic diagnosis. Results Median age was 65 years and 70% were men. Most patients had leukemia (32%) or lymphoma (40%). Eighty-seven of 92 patients (95%), who received single 6-mg dose of rasburicase, achieved a uric acid less than 7.5 mg/dL within 24–36h of dosing. Body mass index was similar between responders and non-responders: 28.6 kg/m2 vs. 26.6 kg/m2, respectively, p = 0.6. Baseline lactate dehydrogenase levels were similar between the groups: 756 U/L vs. 892 U/L, respectively, p = 0.33. Blood pH values documented within 24 h of first dose of rasburicase were also similar between the two groups (n = 30; 7.33 vs. 7.34 respectively, p = 0.6). However, median baseline uric acid was lower in responders than non-responders: 12.3 mg/dL vs. 17.3 mg/dL, respectively, p = 0.012. Baseline serum creatinine and creatinine clearance were similar between responders and non-responders (2.2 mg/dL vs. 3.95 mg/dL; p = 0.12 and 29 mL/min vs. 16 mL/min; p = 0.11, respectively). Conclusions Higher baseline uric acid levels were observed in patients who did not respond to the first rasburicase dose. In our study, uric acid levels normalized in 95% of patients after a single 6-mg dose of rasburicase indicating that a single 6-mg dose of rasburicase may be sufficient to manage tumor lysis syndrome, for most patients.
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Hummel, Margit, Dieter Buchheidt, Silke Ulm, Sebastian Reiter, and Rudiger Hehlmann. "Successful Treatment of Tumor Lysis Syndrome (TLS) with Low Doses of Rasburicase in Patients with Impaired Renal Function (IRF)." Blood 106, no. 11 (November 16, 2005): 3332. http://dx.doi.org/10.1182/blood.v106.11.3332.3332.
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Abstract Background: TLS commonly occurs in patients with hematologic malignancies and is characterized by elevation of uric acid, potassium and phosphate and by hypocalcemia. A major complication is renal failure caused by precipitation of uric acid and / or calcium phosphate crystals. Standard treatment consists of hydration, correction of electrolyte disturbances and lowering of uric acid. Rasburicase, a recombinant urate oxidase, has proven to be highly effective in lowering serum uric acid levels, and its application is not restricted in patients with renal failure. Costs for a full seven-day course of rasburicase in the dosage recommended are high and amount to approximately 4800 €. Our question was whether patients with TLS and IRF can be treated cost-effectively with low doses of rasburicase. Patients and Methods: 26 patients (16 male, median age 65 yrs, range 16–76) with TLS and IRF were treated with 1–5 doses of rasburicase. Median number of rasburicase doses was 1, the median total dose given was 3 mg (range 1–15 mg) (0,038 mg/kg, range 0,016–0,19 mg/kg). 5 patients had acute leukemia, 13 had lymphoma, 5 had myeloproliferative disease and 3 had solid tumors. In 17 patients TLS was chemotherapy-induced, whereas 9 patients had spontaneous TLS. 10/26 patients had pre-existing chronic renal failure. TLS was classified and graded according to Cairo and Bishop. Laboratory TLS was diagnosed in 3 patients, 23 patients had clinical TLS (grade 1: n = 2, grade 2: n = 12, grade 3: n = 8, grade 4: n = 1). Results: The mean uric acid level before rasburicase administration was 15,35 mg/dl (range 10–22,2 mg/dl), the mean creatinine level was 3,29 mg/dl (range 1,41–8,61 mg/dl). The median rasburicase dose applied was 3,2 % of the dose recommended by the manufacturer (0,2 mg/kg for 5–7 days). Rasburicase was well tolerated by all patients without side effects. The mean serum uric acid level after rasburicase was 3,45 mg/dl (range 0,1–13 mg/dl). In 5 patients uric acid was above the upper limit of normal after rasburicase treatment; 3 of these patients had progressive malignant disease and died of disease progression, 2 of these patients had pre-existing chronic renal failure. Serum creatinine was within the normal range after rasburicase treatment in 16/26 patients. Of those patients without normalization of creatinine, 4 had progressive malignant disease and 5 had pre-existing chronic renal failure. No patient required renal replacement therapy. Conclusion: Treatment with low doses of rasburicase is effective in patients with TLS and IRF. Serum uric acid levels can be lowered effectively and renal function is improved in the majority of patients. Treatment costs can be reduced considerably (from 4800 € to approximately 160 €) by administering low doses of rasburicase. The effectiveness of low dose rasburicase was limited in patients with progressive malignant disease and ongoing tumor lysis and in patients with pre-existing chronic renal failure. Prospective studies with a standardized protocol for rasburicase administration are required to establish specific dosage regimens for subgroups of patients and to optimize cost-effective treatment.
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Myers, Regina M., Kelly D. Getz, Yimei Li, Yuan-Shung V. Huang, Rebecca Citrin, Caitlin W. Elgarten, Benjamin L. Laskin, Joseph P. Horowitz, Brian T. Fisher, and Richard Aplenc. "Comparative Effectiveness of Rasburicase and Allopurinol in Children with Acute Lymphoblastic Leukemia: An Emulated Pragmatic Trial Using Observational Data." Blood 132, Supplement 1 (November 29, 2018): 830. http://dx.doi.org/10.1182/blood-2018-99-114883.
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Abstract Introduction: Children with newly diagnosed acute lymphoblastic leukemia (ALL) are at risk for developing tumor lysis syndrome (TLS), an oncologic emergency with potentially severe consequences. Effective TLS management centers on prevention, achieved in large part through control of hyperuricemia with allopurinol or rasburicase. Though rasburicase is known to be very effective for children at high TLS risk, there are limited evidence-based data to guide its usage. Currently available guidelines rely on expert opinion and provide conflicting recommendations, especially for patients at intermediate TLS risk. To address this data gap, we emulated a randomized clinical trial (RCT) to test the efficacy of rasburicase in intermediate risk TLS. We hypothesized that rasburicase would not provide benefit for children with ALL who were classified as being at intermediate TLS risk based on white blood cell count (WBC), uric acid (UA), and creatinine (Cr). Study Design: We used observational data from the Pediatric Health Information Systems (PHIS) administrative database to emulate a RCT assessing the effectiveness of rasburicase initiation (Hernan & Robins Am J Epidemiol. 2016). The source population consisted of the subset of an established cohort of newly diagnosed ALL patients, who were treated at 6 centers that contributed laboratory values to PHIS from 2007-2012. We mimicked rasburicase initiation trials ("pseudo-trials") over time, where each day of the initial diagnostic admission (up to day 4) represented the start of a new pseudo-trial. For each pseudo-trial, a child was considered eligible if he received at least one dose of allopurinol or rasburicase and had a maximum WBC <100/mL, UA <10mg/dL, and Cr <1.5 times the upper limit of normal (ULN) during the 2-day baseline evaluation window. Each child could thus contribute to a maximum of 4 pseudo-trials. For each trial, children were assigned to the non-initiator arm if they received allopurinol-only, or to the rasburicase-initiator arm if they started rasburicase. Rasburicase exposed patients were not eligible for subsequent trials. Study Outcome: The primary outcome was acute kidney injury (AKI), defined as a Cr >1.5 times the ULN. Secondary outcomes were receipt of dialysis, inpatient length of stay (LOS) and mortality. Follow-up for the outcomes started on day 3 of each pseudo-trial and ended 7 days later for AKI and dialysis or 35 days later for LOS and mortality. An intention-to-treat analysis was used. To adjust for potential confounding by baseline covariates, the propensity to receive rasburicase was estimated using a logistic regression model that informed calculation of inverse probability weights (IPW). IPW-adjusted frequency tables were constructed for AKI, dialysis, and mortality. For LOS, linear regression models with IPW and generalized estimating equations for repeated trials were used. Results: Of 945 eligible children, 44 initiated rasburicase (ever-initiators) and 901 never initiated rasburicase (never-initiators). Compared to the non-initiators, ever-initiators were more likely to be male (p=0.040), non-Hispanic white (p=0.018), have private insurance (p=0.028), and have higher WBC (p<.0001), UA (p<.0001) and creatinine (p=0.019) at baseline. The final analyses included 3,175 eligible trial patients. IPW-adjusted analyses suggested no differences in frequency of AKI (2.72% vs. 0.34%, p=0.545), receipt of dialysis (0.51% vs. 0%, p=1.000), mortality (0.06% vs. 0.04% p=1.000) or inpatient LOS (mean 14.7 days vs. 11.0 days, p=0.18) between the initiator and non-initiator arms. Conclusion: Our results suggest that administration of rasburicase may not decrease the frequency of AKI, receipt of dialysis, mortality or decrease LOS for children with newly diagnosed ALL at intermediate TLS risk. Though only 44 rasburicase initiators were identified, which limited the power, these results represent data from the largest pediatric ALL cohort with both laboratory values and resource utilization. If replicated in other cohorts, such findings have the potential to impact guidelines for rasburicase use and greater standardization of rasburicase utilization across centers. Similar to previous reports, we also found that males were more likely to initiate rasburicase, a finding that deserves further exploration, given that males are more likely to have G6PD deficiency, a contraindication to rasburicase use. Disclosures Fisher: Pfizer: Research Funding; Merck: Research Funding.
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Yim, Barbara T., Rosalyn P. Sims-McCallum, and Pang H. Chong. "Rasburicase for the Treatment and Prevention of Hyperuricemia." Annals of Pharmacotherapy 37, no. 7-8 (July 2003): 1047–54. http://dx.doi.org/10.1345/aph.1c336.
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OBJECTIVE: To review the information currently available on rasburicase for treatment and prevention of hyperuricemia. DATA SOURCES: MEDLINE (1966–August 2002) was searched for primary and review articles. STUDY SELECTION/DATA EXTRACTION: Studies evaluating rasburicase, including abstracts and proceedings, were considered for inclusion. English-language literature was evaluated for the pharmacology, pharmacodynamics, pharmacokinetics, therapeutic use, and adverse effects of rasburicase. DATA SYNTHESIS: Rasburicase, a recombinant urate oxidase, has been shown to be effective in lowering uric acid and preventing uric acid accumulation in patients with hematologic malignancies who had hyperuricemia or who were at high risk for developing hyperuricemia. It has been approved for pediatric use in the US. CONCLUSIONS: In addition to allopurinol, hydration, and urinary alkalinization, rasburicase is a new alternative for the treatment and prevention of hyperuricemia in patients with hematologic malignancies. Its rapid onset of action and the ability to lower preexisting elevated uric acid levels are the advantages of rasburicase compared with allopurinol. It may allow the patient to receive chemotherapy treatment without delay.
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Ishizawa, Kenichi. "Clinical trials of rasburicase." Gout and Nucleic Acid Metabolism 30, no. 2 (2006): 203–9. http://dx.doi.org/10.6032/gnam1999.30.2_203.
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Cairo, Mitchell S., Stephen Thompson, Krishna Tangirala, and Michael T. Eaddy. "Costs and Outcomes Associated with Rasburicase Versus Allopurinol in Patients with Tumor Lysis Syndrome." Blood 120, no. 21 (November 16, 2012): 3175. http://dx.doi.org/10.1182/blood.v120.21.3175.3175.
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Abstract Abstract 3175 Background: Tumor lysis syndrome (TLS) is an oncologic emergency resulting in several metabolic abnormalities (Cairo et al, BJH, 2004). Hyperuricemia and its associated complications are the most frequent manifestations of TLS. For decades, treatment has consisted of hydration, urine alkalinization, and administration of allopurinol (Cairo et al BJH, 2011). However, recent clinical trials have shown that initiation of rasburicase, a hypouricemic agent, within four hours significantly reduces high uric acid (UA) levels in patients experiencing TLS (Goldman et al Blood, 2001). Studies demonstrate that rasburicase is safe and effective, has excellent tolerability, and is potentially cost-effective in patients at high risk for TLS. Objective: The objective of this retrospective analysis was to evaluate real-world differences in UA levels, length of stay and costs for patients initiating treatment with rasburicase compared to patients receiving allopurinol. Methods: A retrospective study, spanning January 1, 2005 to March 31, 2009, was conducted utilizing administrative data from more than 400 U.S. hospitals. Hospitalized patients with clinically confirmed TLS, who received rasburicase or allopurinol during the study period were eligible for inclusion. Patients with a diagnosis of gout, as determined by the presence of an ICD-9 diagnosis code 274.x, were excluded from the study. Patients receiving rasburicase were propensity score matched to allopurinol-treated patients in a 1:4 ratio based on time between hospital admission and treatment initiation, baseline UA level, cancer type, age, gender, race, hospital characteristics, payer type, and prior intensive-care unit (ICU) admission. Differences in length of stay (LOS), changes in UA levels and serum creatinine, days in the ICU, and costs per percent of UA reduction were assessed through various statistical models. Due to a high level of missing cancer diagnosis, comparative results of rasburicase and allopurinol were also evaluated through sensitivity analysis to test the robustness of the results. Results: A total of 130 patients were identified, matched and included in this study; 26 initiated treatment with rasburicase and 104 were treated with allopurinol. Patients were predominately male (∼61%) Caucasian (∼76%) with an average age of 55 years. There were no statistically significant differences among baseline variables between the two cohorts. Prior to initiating treatment, mean UA levels were 11.4 mg/dL for the rasburicase cohort and 11.2 mg/dL for allopurinol cohort. By the second day of treatment mean UA levels were 5.3 mg/dL (p<0.0001) lower for rasburicase (2.7mg/dL) compared to allopurinol (8.0 mg/dL). Changes in potassium, phosphorus and creatinine levels were not statistically different across the two cohorts. The LOS for patients in the rasburicase cohort averaged 11.5 days compared to 16.5 days for allopurinol patients (p=0.0212); rasburicase patients also had a lower ICU LOS, 1.4 and 3.9 days, respectively (p<0.0001). The reduction in LOS correlated with a reduction in costs, which averaged $34,065 per rasburicase patient compared to $54,103 per allopurinol patient (p=0.0205). Results of the sensitivity analyses did not change the overall findings. Conclusions: This retrospective study, using hospital administrative data, revealed that treatment with rasburicase, compared with allopurinol, was associated with a significant reduction in UA levels, ICU LOS, overall LOS and overall costs per patient. Despite the increase pharmaceutical costs of rasburicase versus allopurinol, the use of rasburicase in patients with TLS is cost effective and reduces LOS. Disclosures: Cairo: sanofi aventis: Consultancy. Thompson:sanofi aventis: Employment. Tangirala:sanofi aventis: Employment. Eaddy:Xcenda: Employment.
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Trifilio, S., M. Tallman, S. Singhal, L. Gordon, A. Evens, and J. Mehta. "Low-Dose Recombinante Urate Oxidase (Rasburicase) Is Effective in Hyperuricemia." Blood 104, no. 11 (November 16, 2004): 3312. http://dx.doi.org/10.1182/blood.v104.11.3312.3312.
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Abstract Hyperuricemia is a feature of tumor lysis syndrome (TLS), and is treated with hydration, urine alkalinization, and allopurinol. Allopurinol inhibits the conversion of hypoxanthine to xanthine, and xanthine to uric acid (UA) by inhibiting xanthine oxidase. It has no direct effect on existing UA. Rasburicase lowers UA rapidly to very low levels at the labeled dose of 0.15–0.2 mg/kg daily for 5 days by converting UA to allantoin which is rapidly excreted. Despite this dramatic effect on UA, rasburicase has not been shown to have any beneficial impact on survival. We administered 0.2 mg/kg ideal body weight rasburicase to an obese hyperuricemic patient (actual 120 kg, ideal 60 kg). Serum UA declined from 11 mg/dL to 1.4 mg/dL in 3 h and 0.4 mg/dL in 11 h. The serum UA level remained low for several days and a second dose was not needed. After seeing this dramatic and sustained response, low rasburicase doses were used in patients with malignant diseases with close monitoring of biochemical parameters. No dose level was systematically explored and the doses used ranged from 1.5 mg to 12 mg. This analysis is a retrospective review of all patients who received low-dose rasburicase. 23 adults (39–78 y) with cancer and hyperuricemia received a single low dose of rasburicase at 12 mg (n=1; index case), 6 mg (n=2), 4.5 mg (n=1), 3 mg (n=18), and 1.5 mg (n=1). 6 patients received 1 and 1 patient received 2 more doses of 3 mg each. Allopurinol and other supportive therapy including hydration were administered. UA levels (baseline 7.4–19 mg/dL, median 11.6) declined by 4–96% (median 40%) within 24 h of rasburicase administration (Fig 1; the dashed lines show patients receiving more than 1 rasburicase dose). Figure Figure The decline was 31–68% (median 46%) amongst the 12 patients receiving a single 3 mg dose (Fig 2). Figure Figure The baseline serum creatinine was 0.9–8.4 mg/dL (median 2.4), and the minimum and maximum values in the week following rasburicase were 0.7–5.8 (median 1.8) and 1.0–8.8 (median 2.6) respectively. No clinically significant renal dysfunction developed in any patient. The total rasburicase dose administered, 3–12 mg (median 3 mg), was 3–12% (median 5%) of the recommended dose. Based on the Red Book rasburicase cost of $387 for a 1.5 mg vial, the amount of money saved ranged from $11,000 to $29,000 per patient; for a total saving of between $373,000 and $507,000. While this was not a systematic dose-reduction study and patients were treated by multiple physicians and pharmacists on clinical grounds, the data suggest that rasburicase is effective at a fraction of the recommended dose. While a formal investigation of low doses is warranted, we recommend using rasburicase at a standard dose of 3 mg in hyperuricemic patients, checking UA levels frequently, and repeating rasburicase administration if needed. This approach has the potential for substantial cost saving while providing appropriate therapy to lower UA.
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Jane, Hutchinson Lauren. "P01 A retrospective observational study of the use of rasburicase within a tertiary paediatric oncology centre." Archives of Disease in Childhood 103, no. 2 (January 19, 2018): e1.4-e1. http://dx.doi.org/10.1136/archdischild-2017-314584.12.
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Rasburicase is used for the treatment and prophylaxis of hyperuricaemia in patients with haematological malignancy at high risk of tumour lysis syndrome (TLS). It is licensed in both adults and children at a dose of 0.2 mg/kg/day for up to 7 days. In adults off label dosing of 3 mg stat is being used for the prophylaxis of TLS and, whilst not licensed, has been recommended by the British Society for Haematology (BSH) TLS guidelines (Jones et al., 2015). Consequently this has been translated to paediatric use, with our centre using a dose of 0.2 mg/kg (max 3 mg). The aim of this audit is to establish the current prescribing practice for rasburicase within this paediatric oncology centre and ascertain whether its use is in line with BSH recommendations for TLS management in paediatrics.MethodPaediatric patients who had received rasburicase within the previous 12 months were identified via the pharmacy dispensing system. For each patient data was collated from the medical notes, drug chart and blood results. The patient’s risk for TLS was defined, the intended use of rasburicase (treatment or prophylaxis) was established and each patient was assessed for laboratory and clinical signs of TLS according to BSH guidelines.ResultsEleven patients received rasburicase within the previous twelve months. Six were initiated on prophylactic dosing versus five on treatment.Seven out of eleven patients were classed as high risk of TLS, three of which were given a single prophylactic dose of rasburicase and four given treatment.Of the three high risk patients who received rasburicase prophylaxis, one was capped at 3 mg and subsequently converted to treatment due to escalating TLS. This patient received allopurinol concurrently with rasburicase.Three non high risk patients received prophylactic rasburicase. Two showed laboratory signs of TLS and received capped doses of 3 mg. One patient had no access for bloods and was given an uncapped prophylactic dose.The average number of prophylactic doses given per patient was 1.8.Five out of six patients who received treatment rasburicase showed laboratory signs of TLS. The average duration was 4.1 days.ConclusionThe results show inconsistency in the prescribing of rasburicase at this paediatric oncology centre, particularly for TLS prophylaxis. Some patients received capped prophylactic dosing whilst others did not. BSH guidance does not recommend a dose cap of 3 mg in paediatrics due to a lack of evidence whereas the local guideline does. One patient received both allopurinol and rasburicase – the BSH guidance advises this as unnecessary with the potential to reduce the efficacy of rasburicase. TLS treatment with rasburicase was more consistent with five out of six patients being treated in line with BSH guidance and the product license.ReferenceJones GL, Will A, Jackson GH, Webb NJ, Rule S. Guidelines for the management of tumour lysis syndrome in adults and children with haematological malignancies on behalf of the British committee for standards in haematology. Br J Haematol2015;169:661–671.
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Ranjan, Alok, Nisha Khanna, Vivek Ranjan, and Ashwin Kumar. "Follow-Up Study on Management of Tumour Lysis Syndrome with Single Low Fixed Dose (1.5 mg) of Rasburicase - A Tertiary Cancer Centre Experience from India." Journal of Evidence Based Medicine and Healthcare 8, no. 25 (June 21, 2021): 2149–54. http://dx.doi.org/10.18410/jebmh/2021/403.
Full textAbstract:
BACKGROUND Rasburicase (recombinant urate oxidase) has been proven to be an effective therapy for prevention of tumour lysis syndrome (TLS). The recommended daily dosing regimen of rasburicase is 0.2 mg/kg/day for 5 days which is expensive and unaffordable to many patients in the developing countries. The purpose of the present study was to evaluate the effect of single 1.5 mg dose rasburicase in the management of tumour lysis syndrome. METHODS This is a follow-up study done at our institute. Fifty (50) patients with tumour lysis syndrome who received rasburicase from August 2015 to January 2020 were enrolled in this study RESULTS Single dose of rasburicase is effective in decreasing serum uric acid level in significant number (N = 41) of patients. Percentage of patients having uric acid less than 7 mg after single dose of rasburicase in 48 hours - 82.9 % (N = 34) while 17 % (N = 7) were found to have uric acid levels of more than 7 mg/dl. The percentage of patients with uric acid levels more than 7 mg/dl reduced from 36.5 % after 24 hours to 17 % after 48 hours. This indicates that the uric acid levels show a declining trend even after 24 hours without giving an additional dose of rasburicase. There was no relationship between uric acid levels at 24 hours and percentage change in creatinine level from baseline to 24 hours (correlation coefficient (r) = -0.047, P = 0.770. Patients who required additional dose (N = 9) had high base line value of uric acid and their high value was maintained over the follow up period of three days. Patients with pre exiting kidney disease and high level of baseline uric acid also needed dialysis (N = 3). CONCLUSIONS In majority of patients, a single 1.5 mg dose of rasburicase is an effective way to reduce raised uric acid in appropriate circumstances. KEYWORDS Single Dose, Recombinant Urate Oxidase, Uric Acid, Leukemia, Tumour Lysis Syndrome, Rasburicase
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Ponnada, Bharadwaj, Saadvik Raghuram, Sanketh Kotne, and Pavithran Keechilat. "The value of low, fixed, single dose rasburicase in the prevention and treatment of tumor lysis syndrome." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): e18558-e18558. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e18558.
Full textAbstract:
e18558 Background: Rasburicase is a recombinant urate oxidase drug approved by the US FDA for the management of hyperuricemia in Tumor Lysis Syndrome (TLS). Recommended dose of 0.2 mg/kg/day for 5 days is expensive and the benefit of extended schedule compared to a single fixed dose of 1.5 mg is not known. Methods: This is a retrospective cohort study done at a tertiary medical center including 165 (144 adult and 21 pediatrics) patients admitted between January 2013 and December 2018. We analyzed the efficacy of single low dose rasburicase 1.5 mg irrespective of bodyweight in adults and in children a dose of 0.15 mg/kg (maximum 1.5 mg) intravenously over 30 min for prevention and treatment of TLS and subsequent doses were given based on clinical and biochemical response. Plasma samples for uric acid were collected at baseline, 6–24 hrs, 48 hrs post-rasburicase, and daily during treatment. The primary outcome was achieving a uric acid level less than 7.0 mg/dl after a single dose of rasburicase in the groups. Secondary outcomes included need for repeat rasburicase doses, and a cost analysis. Results: Children accounted for 12.1% (n = 20) and adults 87.9% (n = 145). The median ages in pediatric and adult groups were 7.9 years and 54 years respectively. Rasburicase was used prophylactically in 35 (21.2%), for laboratory TLS in 105 (63.6%) and for clinical TLS in 25 (15.2%) patients. SDR prevented laboratory/clinical TLS in 89% of the prophylactic group and prevented clinical TLS in 72% of the laboratory TLS group. However, 92%(n=23) of the patients with clinical TLS required more than one dose rasburicase. The average total monthly cost of rasburicase was reduced by 96% ($2850 to $114) after adoption of the above protocol. Conclusions: Single low dose rasburicase is a highly economical and clinically effective way of managing patients with TLS and could serve as an alternative to the 5-day treatment. This dose, therefore, balances cost and efficacy of treatment.
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"Rasburicase." Reactions Weekly 1851, no. 1 (April 2021): 322. http://dx.doi.org/10.1007/s40278-021-94412-4.
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"Rasburicase." Reactions Weekly 1925, no. 1 (September 24, 2022): 440. http://dx.doi.org/10.1007/s40278-022-24217-5.
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"Rasburicase." Reactions Weekly 1877, no. 1 (October 2021): 345. http://dx.doi.org/10.1007/s40278-021-03915-7.
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"Rasburicase." Reactions Weekly 1878, no. 1 (October 2021): 460. http://dx.doi.org/10.1007/s40278-021-04430-z.
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"Rasburicase." Reactions Weekly 1862, no. 1 (July 2021): 428. http://dx.doi.org/10.1007/s40278-021-98546-0.
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"Rasburicase." Reactions Weekly 1871, no. 1 (September 2021): 362. http://dx.doi.org/10.1007/s40278-021-01881-8.
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"Rasburicase." Reactions Weekly 1896, no. 1 (March 2022): 405. http://dx.doi.org/10.1007/s40278-022-11193-z.
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"Rasburicase." Reactions Weekly 1926, no. 1 (October 1, 2022): 407. http://dx.doi.org/10.1007/s40278-022-24685-3.
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"Rasburicase." Reactions Weekly 1691, no. 1 (March 2018): 235. http://dx.doi.org/10.1007/s40278-018-42490-6.
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"Rasburicase." Reactions Weekly 1692, no. 1 (March 2018): 308. http://dx.doi.org/10.1007/s40278-018-42835-4.
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