ELITEK® (rasburicase) IV Infusion

A series of 3 clinical trials was conducted

ELITEK was administered to 265 patients (pooled) with hematologic malignancies¹
93% (246/265) of patients (pooled) enrolled in these clinical trials were pediatric¹
77% (200/261) of evaluable patients (pooled) had normal uric acid levels (<8 mg/dL) at baseline¹
ELITEK was administered prior to and concurrent with antitumor therapy¹
95% (251/265) of patients (pooled) were administered a 30-minute infusion once daily; the others (14/265) received infusions twice daily¹

ELITEK Pediatric Brochure

Reference the Pediatric Brochure to see the ELITEK trial designs and results for a pediatric patient population

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SEE PEDIATRIC EFFICACY

ELITEK was studied in pediatric patients at high risk of tumor lysis syndrome (TLS) associated with hyperuricemia²

100%

of pediatric patients were at high
risk at baseline

63%

of pediatric patients had normal
uric acid levels (<8 mg/dL)
at baseline

Patients meeting at least 1 of the following criteria were enrolled in the trial²:

Murphy stage III or IV NHL
ALL with peripheral WBC count of ≥25,000/µL at presentation
Any childhood lymphoma or leukemia with a uric acid level of ≥8 mg/dL at the time of study

Additional eligibility criteria were life expectancy of ≥4 weeks and an ECOG PS ≤3, or a Karnofsky scale of ≥30%.²

Antihyperuricemic therapy in both arms was initiated prior to anticancer therapy¹

Phase 3: a randomized, multicenter, open-label, controlled study in pediatric patients (N=52) with leukemia or lymphoma at high risk for TLS associated with hyperuricemia^1,2
Primary endpoint: reduction in uric acid levels measured from the last value prior to the first dose of study drug until 4 days (96 hours) after that first dose (AUC_{0-96 hr}) of ELITEK vs allpurinol¹

PEDIATRIC CLINICAL TRIAL DESIGN¹*

Pediatric clinical Trial Design for Study 1 shows a chart of two rows comparing those randomized 1:1:1 (N=52) given either ELITEK in magenta blocks (n=27), 0.2 mg/kg once (n=26) or twice (n=1) daily or an allopurinol in grey blocks (n=25) dose varied according to local institutional practice for days 1-2 separated by a dashed line from days 3-5 to show results of Anticancer therapy initiated 4 to 48 hours after the final antihyperuricemic dose.

^*Actual deviations from study protocol occurred in 2/52 patients (antitumor therapy was same as first administration of ELITEK or may have been prior to ELITEK administration).^1,2

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

SEE STUDY 1 RESULTS

ELITEK was studied in majority-pediatric patients at high, intermediate, and low risk of TLS associated with hyperuricemia³

69%

of patients were at high or
intermediate risk at baseline

88%

of patients had normal uric acid
levels (<8 mg/dL) at baseline

Patients meeting at least 1 of the following criteria were enrolled in the trial³:

NHL ≥ stage III
NHL ≥ stage II with high tumor burden defined as LDH level twice or more the ULN and/or tumor mass with a diameter ≥10 cm
ALL or acute non-lymphoid leukemia

Additional eligibility criteria were life expectancy of ≥4 weeks and Karnofsky scale of ≥30% or an ECOG PS ≤3.³

Patients were stratified based on risk levels defined as³:

Pediatric clinical Trial results for Study 2 (N=107) shown in a grey table format where patient parameters were based on Classification at Baseline WBC (x109/L), LDH (ULN), hyperuricemia (uric acid _> mg/dL). For sponsor-defined risk classification at baseline Low results were _< 25 for Baseline WBC (x10/L) immediately prior to first dose of study drug, _<2 x ULN for Baseline LDH (ULN) immediately prior to first dose of study drug and No for Baseline hyperuricemia (uric acid _>8 mg/dL), for Intermediate, all patients not considered to be at low or high risk for intermediate, and for High _>50 and/or for Baseline WBC (x109/L), _>5x ULN and/or for Baseline LDH (ULN) and Yes for Baseline hyperuricemia (uric acid _>8 mg/dL).

^†Immediately prior to first dose of study drug.

ELITEK was administered prior to and concurrent with anticancer therapy¹

A multicenter, single-arm study conducted in 107 patients (89 pediatric, 18 adult) with hematologic malignancies at risk for TLS associated with hyperuricemia^1,3
Primary endpoint: maintenance of uric acid levels ≤6.5 mg/dL (patients <13 years) or ≤7.5 mg/dL (patients ≥13 years) within 48 hours post-initiation of ELITEK until 24 hours after last administration without the need for allopurinol or other agents¹

PEDIATRIC CLINICAL TRIAL DESIGN^1,3‡

A blocked magenta table showing Pediatric Trial Design for Study 2 (n=107) patients received ELITEK at a dose of 0.15 mg/kg/day for Day 1 and 2 with a dashed line separating Anticancer therapy results initiated 4 to 48 hours after the first antihyperuricemic dose in days 3 through 7.

^‡Actual deviations from study protocol occurred in 2/107 patients (antitumor therapy given prior to first administration of ELITEK); presumed deviations from study protocol occurred in 18/107 patients (antitumor therapy was same as first administration of ELITEK or may have been prior to ELITEK administration).³

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

SEE STUDY 2 RESULTS

ELITEK was studied in majority-pediatric patients at high, intermediate, and low risk of TLS associated with hyperuricemia³

69%

of patients were at high risk at
baseline

58%

of patients had normal uric acid
levels (<8 mg/dL) at baseline

Patients meeting at least 1 of the following criteria were enrolled in the trial³:

Small, noncleaved-cell (Burkitt or non-Burkitt) NHL ≥ stage III
B-cell leukemia (of Burkitt type) with L₃morphology by FAB classification
ALL with WBC count ≥50,000/mm³
ALL without regard to WBC count, but with clinical, radiological, or laboratory evidence of high tumor burden that, in the opinion of the investigator, would produce significant hyperuricemia during tumor lysis
Lymphoblastic lymphomas ≥ stage Ill with clinical, radiological, or laboratory evidence of high tumor burden that, in the opinion of the investigator, would produce significant hyperuricemia during tumor lysis
Lymphoma or leukemia with a uric acid level of ≥8 mg/dL and either creatinine or LDH level at least twice the ULN

Additional eligibility criteria were life expectancy of ≥4 weeks and Karnofsky scale of ≥30% or an ECOG PS ≤3.³

Patients were stratified based on risk levels defined as³:

Chart shows Study 3 pediatric patients Parameters and Sponsor-Defined Risk Classification at Baseline WBC (x109/L), LDH, hyperuricemia (uric acid _>8 mg/dL). Low, intermediate, and high categories. For sponsor-defined risk classification at baseline Low results were _< 25 for Baseline WBC (x10/L) immediately prior to first dose of study drug, and _<2 x ULN for Baseline LDH (ULN) immediately prior to first dose of study drug and No for Baseline hyperuricemia (uric acid _>8 mg/dL), for Intermediate, all patients not considered to be at low or high risk, and for High _>50 for Baseline LDH (ULN) and/or _>5x ULN for Baseline LDH (ULN) and/or Yes for Baseline hyperuricemia (uric acid _>8 mg/dL).

^†Immediately prior to first dose of study drug.

ELITEK was administered prior to and concurrent with anticancer therapy¹

A multicenter, single-arm study conducted in 131 patients (130 pediatric, 1 adult) with hematologic malignancies at risk for TLS associated with hyperuricemia^1,3
Primary endpoint: maintenance of uric acid levels ≤6.5 mg/dL (patients <13 years) or ≤7.5 mg/dL (patients ≥13 years) within 48 hours post-initiation of ELITEK until 24 hours after last administration without the need for allopurinol or other agents¹

PEDIATRIC CLINICAL TRIAL DESIGN^1,3‖

A blocked magenta table showing Pediatric Trial Design for Study 3 (n=131) patients received ELITEK at either a dose of 0.15 mg/kg/day (n=12) or 0.2 mg/kg/day (n=119) for Day 1 and 2 with a dashed line separating Anticancer therapy results initiated 4 to 48 hours after the first antihyperuricemic dose in days 3 through 7.

^IIActual deviations from study protocol occurred in 3/131 patients (antitumor therapy given prior to first administration of ELITEK); presumed deviations from study protocol occurred in 13/131 patients (antitumor therapy was same as first administration of ELITEK or may have been prior to ELITEK administration).³

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

SEE STUDY 3 RESULTS

See how these pediatric patients responded to treatment with ELITEK

SEE PEDIATRIC EFFICACY

ALL=acute lymphocytic leukemia; ECOG PS=Eastern Cooperative Oncology Group Performance Scale; FAB=French-American-British; IV=intravenous; LDH=lactate dehydrogenase; NHL=non-Hodgkin’s lymphoma; ULN=upper limit of normal; WBC=white blood cell.

References: 1. ELITEK [prescribing information]. NJ: sanofi-aventis U.S. LLC. 2. Goldman SC, Holcenberg JS, Finkelstein 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. 3. Data on file. Bridgewater, NJ: sanofi-aventis U.S. LLC.

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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Prophylactic Use of ELITEK® (rasburicase) IV Infusion Was Studied in Pediatric Patients

A series of 3 clinical trials was conducted

ELITEK Pediatric Brochure

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Pediatric Brochure

Study 1

Study 2

Study 3

See how these pediatric patients responded to treatment with ELITEK

Important Safety Information

Contraindictions

Adverse Reactions

Use in Specific Populations

Indication

Important Safety Information

Indication

Prophylactic Use of ELITEK^® (rasburicase) IV Infusion Was Studied in Pediatric Patients