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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.

About ELITEK (rasburicase)

ELITEK Rapidly (4 Hours) Transforms Uric Acid Into Allantoin²

ELITEK (rasburicase) is a recombinant urate oxidase enzyme. It 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 anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ELITEK (rasburicase) is indicated for only a single course of treatment.²

• ELITEK reduces circulating uric acid levels as soon as 4 hours after the 1^st dose, while current therapy has no effect on uric acid already formed.^1,2,22
• ELITEK allows for fast initiation (4 hours up to 24 hours after the 1^st dose) of cytoreductive therapy in patients who are at risk of or present with hyperuricemia associated with tumor lysis syndrome (TLS).^1,2
• ELITEK offers once-daily IV dosing.²
• ELITEK is contraindicated in patients with glucose-6-phosphate dehydrogenase G6PD deficiency.²
• ELITEK has no effect on xanthine; it is active only at the end of the purine catabolism pathway.^1,2,22 Theoretically, increased urinary xanthine may lead to the formation of xanthine calculi.^1,22
• ELITEK's development was based on DNA-recombinant technology.²
• ELITEK is a recombinant form of urate oxidase.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 adult 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 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.

RELIABLE: 87% of ELITEK-treated adult patients maintained uric acid concentrations ≤7.5 mg/dL vs 66% of allopurinol patients from the initiation of antihyperuricemic therapy.²

*Response rate in the ELITEK-alone arm was statistically greater than response rate in the allopurinol arm. However, the response rate for ELITEK/allopurinol (78%) was not statistically significant vs ELITEK.²⁰

Adult Study: Percent Incidence of Selected Grade 3/4 Adverse Reactions By Study Arm²

*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 arm and the difference between any ELITEK (rasburicase) arm versus the allopurinol arm ≥5%.

Plasma Uric Acid Concentrations Maintained Over Time²²

The data shown are extracted from a select patient population from Study 3 (ACT 2694) who received an ELITEK dose of 0.20 mg/kg once daily for 5 days (n = 93)²²
Study 3 was a single-arm Phase II study conducted in 130 pediatric patients and 1 adult patient with hematologic malignancies. One hundred and nineteen pediatric patients received an ELITEK dose of 0.20 mg/kg once daily, of whom 93 did so for 5 days. The primary efficacy objective was determination of the proportion of patients with plasma uric acid levels maintained under control at 48 hours following initiation of ELITEK.²²

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

• 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.