ELITEK® (rasburicase) IV Infusion

Pooled efficacy data from 3 studies

Data from Study 1, 2, and 3 (n=265) were pooled and analyzed according to the plasma uric acid levels over time¹
93% (246/265) of patients (pooled) enrolled in these clinical trials were pediatric¹
98% (261/265) of enrolled patients were evaluable: 77% (200/261) of patients were nonhyperuricemic (<8 mg/dL) at baseline and 23% (61/261) of patients were hyperuricemic (≥8 mg/dL) at baseline¹

In 3 clinical trials, ELITEK^® (rasburicase) IV Infusion maintained normal uric acid levels in 100% of evaluable patients by Day 4¹

Evaluable patients maintaining normal uric acid levels (≤6.5 mg/dL for patients <13 years of age or ≤7.5 mg/dL for patients ≥13 years of age) 4 days post-initiation of ELITEK¹

A bar chart in magenta colors showing in 3 clinical trials efficacy percentage of patients maintaining uric acid levels all at 100% for Nonhyperuricemic (<8 mg/dL) at baseline (n=200), Hyperuricemic (≥8 mg/dL) at baseline (n=61) and Total (n=261).

Of the 261 evaluable patients in Study 1, 2, and 3 (pooled)¹:
- Normal uric acid levels were maintained by 92% (240/261) of patients after 4 hours, 93% (245/261) after 24 hours, 97% (254/261) after 48 hours, and 99% (260/261) after 72 hours
- For patients with hyperuricemia (≥8 mg/dL) at baseline (61/261), uric acid levels were maintained by 72% (44/61) after 4 hours, 80% (49/61) after 24 hours, 92% (56/61) after 48 hours, and 98% (60/61) after 72 hours
Maintenance was defined as uric acid levels ≤6.5 mg/dL (patients <13 years of age) or ≤7.5 mg/dL (patients ≥13 years of age) without the need for allopurinol or other agents¹

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In Study 1, pediatric patients receiving ELITEK experienced a more rapid decline vs allopurinol (P<0.0001) and maintained normal uric acid levels throughout treatment^1,2

Mean (± SE) plasma uric acid concentrations over time for all patients²

Graphic showing in colors of magenta and grey for Study 1 the mean plasma uric acid level concentrations over time for all patients. In magenta, 0-96 hr ELITEK (mean AUC 128+_ 70 mg/dL) and in grey 0-96 hr allopurinol (mean AUC 329+_ 129 mg/dL) time from first dose in hours. P<0.0001.

Primary endpoint

The uric acid AUC_{0-96 hr} was significantly lower in the ELITEK group (128 ± SE 14 mg hr/dL) vs the allopurinol group (328 ± SE 26 mg hr/dL)¹

All but 1 patient in the ELITEK arm had reduction and maintenance of uric acid levels to within or below the normal range during the treatment.¹

The incidence of renal dysfunction was similar in the 2 study arms; 1 patient in the allopurinol arm developed acute renal failure.¹

The recommended dose of ELITEK is 0.2 mg/kg as a 30-minute IV infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than 1 course is not recommended.¹

In Study 2, ELITEK maintained normal uric acid levels in 99% of patients receiving 0.15 mg/kg/day by Day 2¹

Pediatric patients maintaining normal uric acid levels (≤6.5 mg/dL for patients <13 years of age or ≤7.5 mg/dL for patients ≥13 years of age) 2 days post-initiation of ELITEK without the need for allopurinol or other agents¹

A magenta bar chart showing study 2 results of pediatric patients receiving ELITEK 0.15 mg/kg/day (n=106/107) at 99% maintained uric acid levels.

Primary endpoint

The proportion of patients with maintenance of normal uric acid levels (≤6.5 mg/dL for patients <13 years of age or ≤7.5 mg/dL for patients ≥13 years of age) at 48 hours in Study 2 was 99% (106/107)¹

The recommended dose of ELITEK is 0.2 mg/kg as a 30-minute IV infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than 1 course is not recommended.¹

In Study 3, ELITEK maintained normal uric acid levels in 92% of patients receiving 0.15 mg/kg/day and 95% of patients receiving 0.2 mg/kg/day by Day 2¹

Pediatric patients maintaining normal uric acid levels (≤6.5 mg/dL for patients <13 years of age or ≤7.5 mg/dL for patients ≥13 years of age) 2 days post-initiation of ELITEK without the need for allopurinol or other agents¹

A magenta bar with upper bar lighter magenta and lower bar darker magenta from Study 3, showing percentage of patients who received ELITEK 0.15 mg/kg/day (n=12) at 92% and ELITEK 0.2 mg/kg/day (n=119) at 95%.

Primary endpoint

The proportion of patients with maintenance of normal uric acid levels (≤6.5 mg/dL for patients <13 years of age or ≤7.5 mg/dL for patients ≥13 years of age) at 48 hours in Study 3 was 92% in the 0.15 mg/kg group (n=12) and 95% in the 0.2 mg/kg group (n=119)¹

The recommended dose of ELITEK is 0.2 mg/kg as a 30-minute IV infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than 1 course is not recommended.¹

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EXPLORE ELITEK MOA

References: 1. ELITEK [prescribing information]. NJ: sanofi-aventis U.S. LLC. 2. Goldman SC, Holcenberg JS, Finklestein JZ, et al. A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis. Blood. 2001;97:2998-3003.

Important Safety Information

WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS

Hypersensitivity Reactions: ELITEK can cause serious and fatal 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 prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection.

Contraindictions

ELITEK is contraindicated in patients with a history of anaphylaxis or severe hypersensitivity to rasburicase or in patients with development of hemolytic reactions or methemoglobinemia with rasburicase. ELITEK is contraindicated in individuals deficient in glucose-6-phosphate dehydrogenase (G6PD).

Adverse Reactions

Most common adverse reactions (incidence ≥20%), when used concomitantly with anticancer therapy, are vomiting, nausea, fever, peripheral edema, anxiety, headache, abdominal pain, constipation, diarrhea, hypophosphatemia, pharyngolaryngeal pain, and increased alanine aminotransferase.

Use in Specific Populations

Pregnancy: Consider the benefits and risks of ELITEK and possible risks to the fetus when prescribing ELITEK to a pregnant woman
Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with ELITEK and for 2 weeks after the last dose

Indication

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 anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.

Limitation of use: ELITEK is indicated only for a single course of treatment.

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Protect Pediatric Patients at Risk from Rising Uric Acid Levels

Pooled efficacy data from 3 studies

In 3 clinical trials, ELITEK® (rasburicase) IV Infusion maintained normal uric acid levels in 100% of evaluable patients by Day 41

Evaluable patients maintaining normal uric acid levels (≤6.5 mg/dL for patients <13 years of age or ≤7.5 mg/dL for patients ≥13 years of age) 4 days post-initiation of ELITEK1

Primary endpoint data for Study 1

Primary endpoint data for Study 2 and Study 3

Important Safety Information

Contraindictions

Adverse Reactions

Use in Specific Populations

Indication

Important Safety Information

Indication

In 3 clinical trials, ELITEK^® (rasburicase) IV Infusion maintained normal uric acid levels in 100% of evaluable patients by Day 4¹

Evaluable patients maintaining normal uric acid levels (≤6.5 mg/dL for patients <13 years of age or ≤7.5 mg/dL for patients ≥13 years of age) 4 days post-initiation of ELITEK¹