Recombinant Urate Oxidase (Rasburicase) in the Prophylaxis and Treatment of Tumor Lysis Syndrome

2004 ◽  
pp. 69-79
Author(s):  
Sima Jeha ◽  
Ching-Hon Pui
Keyword(s):  
Tumor Lysis Syndrome ◽  
Urate Oxidase ◽  
Tumor Lysis

scholarly journals A Comparison of Single Dose Rasburicase 3 Mg Versus 6 Mg for the Management of Tumor Lysis Syndrome

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4511-4511
Author(s):  
Sarah K Kraus ◽  
Catherine E Burdalski ◽  
Colleen Timlin ◽  
Tracy M Krause ◽  
Todd A Miano ◽  
...  
Keyword(s):  
Single Dose ◽  
Research Funding ◽  
Hematological Malignancies ◽  
Tumor Lysis Syndrome ◽  
Wholesale Price ◽  
Cost Savings ◽  
Urate Oxidase ◽  
Categorical Variables ◽  
Tumor Lysis ◽  
Dosing Strategies

Abstract Introduction: Rasburicase, a recombinant form of urate oxidase, is a highly effective treatment for tumor lysis syndrome (TLS). Although the FDA-approved dose for rasburicase is 0.2 mg/kg/day for up to five days, many centers have adopted alternative dosing strategies to decrease cost, the most common being a single 6 mg dose. We hypothesized that further reducing the dose to 3 mg would result in similar efficacy and yield significant cost savings compared to the 6 mg dose strategy. Methods: We conducted a retrospective cohort study to examine the comparative effectiveness of a single 3 mg dose of rasburicase versus a single 6 mg dose in 108 adults with hematological malignancies presenting with a baseline uric acid (UA) ≤ 12 mg/dL between June 2009 and February 2015. Prior to January 2012, our institutional policy recommended a single 6 mg dose for all patients who met criteria for rasburicase for TLS. In January 2012, the policy was amended to recommend a single 3 mg dose for patients with a baseline UA ≤ 12 mg/dL. Thus, the study included 56 patients with UA ≤ 12 who received a single 6 mg dose prior to the policy modification and 52 patients with UA ≤ 12 given the 3 mg dose after the amendment. The primary endpoint was the percentage of patients who achieved a UA ≤ 8 mg/dL (the upper limit of normal at our institution) 24 hours after a single dose of rasburicase. Fisher's exact test was used to analyze categorical variables and t-tests were used to analyze continuous variables. The a priori level of significance was set at α < 0.05. Results: The mean baseline UA was 9.3 mg/dL and 9.8 mg/dL in the 3 mg arm and 6 mg arm, respectively (P = .19). At 24 hours there was no difference in the percentage of patients who achieved a UA ≤ 8 mg/dL (92% vs. 98%; P = 0.36). In addition, there was no difference in the percentage of patients who achieved a UA ≤ 8 mg/dL at 48 hours (98% vs. 100%; P = 0.48). Six (11.5%) patients in the 3 mg arm and one (1.8%) patient in the 6 mg arm required a second dose of rasburicase to achieve a UA <8 mg/dL (P = 0.1). Of note, the 6 mg group had a greater percent reduction in UA from baseline compared to the 3 mg group at both 24 hours (-68.1% vs. -48.6%; P < .01) and 48 hours (-69.3% vs. -51.3%; P = 0.02) after rasburicase administration. There was no difference in the percent change of serum creatinine between the two dosing strategies at 24 hours (-6.5% vs. 0.1%; P = 0.11) or 48 hours (-4.5% vs. -2.5%; P = 0.22). In addition, no difference was observed with respect to the percent of patients who required renal replacement therapy within 7 days of rasburicase administration (8.9% vs. 9.6% P = 1.0). Based on the average wholesale price of $815 for one 1.5 mg vial of rasburicase, the single 3 mg dose was associated with approximately $1,500 cost savings per encounter compared to the 6 mg dose. Conclusion: A single 3 mg dose of rasburicase was as effective as 6 mg in normalizing UA within 24 hours. Our findings demonstrate that administering a single 3 mg dose of rasburicase is a cost-effective alternative for TLS management in patients with hematological malignancies presenting with a UA ≤ 12 mg/dL. Disclosures Svoboda: Immunomedics: Research Funding; Celgene: Research Funding; Seattle Genetics: Research Funding; Celldex: Research Funding. Ganetsky:Onyx: Speakers Bureau.

The economic implications of rasburicase treatment in adult tumor lysis syndrome patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17503-e17503
Author(s):  
M. Eaddy ◽  
K. O’Day ◽  
K. M. Tangirala ◽  
B. Seal
Keyword(s):  
Critical Care ◽  
Combination Therapy ◽  
Linear Models ◽  
Tumor Lysis Syndrome ◽  
Urate Oxidase ◽  
Provider Type ◽  
Pattern Of Care ◽  
Economic Implications ◽  
Tumor Lysis ◽  
Hospitalization Costs

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]

The value of low, fixed, single dose rasburicase in the prevention and treatment of tumor lysis syndrome.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18558-e18558
Author(s):  
Bharadwaj Ponnada ◽  
Saadvik Raghuram ◽  
Sanketh Kotne ◽  
Pavithran Keechilat
Keyword(s):  
Uric Acid ◽  
Single Dose ◽  
Low Dose ◽  
Medical Center ◽  
Day Treatment ◽  
Tumor Lysis Syndrome ◽  
Urate Oxidase ◽  
Fixed Dose ◽  
Tumor Lysis ◽  
Prevention And Treatment

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.

Single 6-mg dose of rasburicase: The experience in a large academic medical center

2018 ◽  
Vol 25 (6) ◽  
pp. 1349-1356 ◽  
Author(s):  
Mary Nauffal ◽  
Robert Redd ◽  
Jian Ni ◽  
Richard M Stone ◽  
Daniel J DeAngelo ◽  
...  
Keyword(s):  
Uric Acid ◽  
Lactate Dehydrogenase ◽  
Serum Creatinine ◽  
Medical Center ◽  
Academic Medical Center ◽  
Tumor Lysis Syndrome ◽  
Urate Oxidase ◽  
Baseline Serum ◽  
Tumor Lysis ◽  
Blood Ph

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.

The economic implications of rasburicase treatment in pediatric tumor lysis syndrome patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 10050-10050
Author(s):  
K. O'Day ◽  
M. Eaddy ◽  
B. Seal ◽  
K. M. Tangirala
Keyword(s):  
Critical Care ◽  
Length Of Stay ◽  
Pediatric Patients ◽  
Tumor Lysis Syndrome ◽  
Urate Oxidase ◽  
Provider Type ◽  
Current Standard ◽  
Economic Implications ◽  
Pediatric Tumor ◽  
Tumor Lysis

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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