Protect pediatric patients at risk from rising uric acid levels

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 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

Percentage of patients maintaining uric acid levels ≤6.5 mg/dL (patients <13 years of age) or ≤7.5 mg/dL (patients ≥13 years of age): 100% of nonhyperuricemic (<8 mg/dL) at baseline (n=200); 100% of hyperuricemic (≥8 mg/dL) at baseline (n=61); 100% 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

SEE PEDIATRIC STUDY DESIGNS

VIEW SAFETY PROFILE

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
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
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
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]. Bridgewater, 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.

INDICATION

ELITEK is indicated for the initial management of plasma uric acid levels in 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 is indicated only for a single course of treatment.

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.

CONTRAINDICATIONS

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

Please see full Prescribing Information, including Boxed WARNING.

MAT-US-2020412-v2.0-08/2022

Last Updated: August 2022-08-01

Protect pediatric patients at risk from rising uric acid levels

Pooled efficacy data from 3 studies

In 3 clinical trials, ELITEK 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

In Study 1, pediatric patients receiving ELITEK experienced a more rapid decline vs allopurinol (P<0.0001) and maintained normal uric acid levels throughout treatment1,2

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

Primary endpoint

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

Primary endpoint

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

Primary endpoint

INDICATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

In 3 clinical trials, ELITEK 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

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

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

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