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Elitek^® is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ELITEK is indicated for only a single course of treatment.

ELITEK (rasburicase) Information

ELITEK (rasburicase) Demonstrated Rapid and Reliable Results in Adult Patients²

• 96% of adult patients experienced uric acid reduction 4 hours after 1st dose.²

Rapid Response

• The difference in time to reach plasma uric acid control did not reach statistical significance.
• The comparison among the different groups was pre-specified in the study protocol.

*Time to uric acid control was defined as time in hours from the first dose of study drug to the sampling time at which a plasma uric acid concentration of less than or equal to 7.5 mg/dL was achieved.

ELITEK (rasburicase) was studied in a randomized, multicenter, open-label, parallel-group study conducted in patients with leukemia, lymphoma, and/or solid tumor malignancies at risk for hyperuricemia and tumor lysis syndrome (TLS). The primary end point was response rate, defined as percentage of patients with plasma uric acid levels maintained at ≤7.5 mg/dL between Day 3 and Day 7 after initiation of antihyperuricemic treatment.

Arm A: Patients received ELITEK (rasburicase) 0.20 mg/kg/day as a 30-minute infusion once daily for 5 days (n = 92).

Arm B: Patients received ELITEK (rasburicase) 0.20 mg/kg/day as a 30-minute infusion once daily from Day 1 through Day 3, followed by oral allopurinol 300 mg once daily from Day 3 through Day 5 (overlap on Day 3: ELITEK (rasburicase) and allopurinol administered ~12 hours apart) (n = 92).

Arm C: Patients received oral allopurinol 300 mg once daily for 5 days
(n = 91).

*Data shown represents mean value of uric acid levels.

• 87% of ELITEK (rasburicase) patients maintained uric acid concentrations ≤7.5 mg/dL.

*Response rate in the ELITEK-alone arm was statistically greater than response rate in the allopurinol arm. However, the response rate for ELITEK/allopurinol was not statistically significant vs ELITEK.²⁰

*Events were reported and graded according to NCI-CTC Version 3.0 and presented as preferred terms MedDRA version 10.1. Overall incidence ≥10% in any ELITEK (rasburicase) arm and the difference between any ELITEK (rasburicase) arm versus the allopurinol arm ≥5%.

ELITEK (rasburicase) Produces Rapid and Effective Reduction in Uric Acid Levels in Pediatric Patients With Hyperuricemia²

• Among 61 patients hyperuricemic^* at baseline (out of 265 patients), ELITEK (rasburicase) produced an 86% reduction in uric acid levels by 4 hours.
• Uric acid concentration was maintained^† in 72% and 100% of ELITEK-treated hyperuricemic patients by 4 and 96 hours, respectively.²

Study Design: A pooled analysis of 3 prospective, controlled clinical studies completed in pediatric patients with acute leukemia or Non-Hodgkin's lymphoma (Studies 1,2, and 3 in US Package Insert).²

*Patients with uric acid concentration ≥8 mg/dL prior to treatment.
^†Maintenance of uric acid concentration was defined as:
1) achievement of uric acid concentration ≤6.5 mg/dL (patients <13 years) or ≤7.5 mg/dL (patients ≥13 years) within a designated time point (48 hours) from initiation of ELITEK (rasburicase) and maintained until 24 hours after the last administration of study drug; and
2) control of uric acid level without the need for allopurinol or other agents.

ELITEK (rasburicase) Produces Rapid and Effective Reduction in Uric Acid Levels in Pediatric Patients at Risk for Hyperuricemia.²

• Among 200 patients at risk for hyperuricemia, ELITEK (rasburicase) produced an 89% reduction in uric acid levels by 4 hours.²

ELITEK (rasburicase) Maintains Normal Uric Acid Levels in All Pediatric Patients in the Studies

• Among 261 patients, ELITEK (rasburicase) maintained uric acid levels below 4 mg/dL in 92% of patients by 4 hours.²

Among the 347 (265 pediatric; 82 adult) patients for whom all adverse reactions regardless of severity were assessed in Studies 1, 2 and 3, as well as an uncontrolled safety trial, the most frequently observed adverse reactions (incidence ≥10%) were vomiting (50%), fever (46%), nausea (27%), headache (26%), abdominal pain (20%), constipation (20%), diarrhea (20%), mucositis (15%), and rash (13%).

Related Articles

• About ELITEK (rasburicase)
• ELITEK (rasburicase) Mechanism of Action
• ELITEK (rasburicase) vs Allopurinol
• ELITEK (rasburicase)Safety

BOXED WARNINGS

Anaphylaxis:
ELITEK can cause severe hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue ELITEK in patients who experience a serious hypersensitivity reaction.

Hemolysis:
Do not administer ELITEK to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue ELITEK in patients developing hemolysis. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting ELITEK.

Methemoglobinemia:
ELITEK can result in methemoglobinemia in some patients. Immediately and permanently discontinue ELITEK in patients developing methemoglobinemia.

Interference With Uric Acid Measurements:
ELITEK enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection.