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For U.S. Healthcare Professionals Only

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PROPHYLACTIC USE OF ELITEK WAS STUDIED IN 3 CLINICAL TRIALS TO PREVENT RISING URIC ACID IN PEDIATRIC PATIENTS1

  • 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 was studied in pediatric patients at high risk of 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 a peripheral white blood cell (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 entry

Additional eligibility criteria were life expectancy of ≥4 weeks and an ECOG ≤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 hyperuricemia1,2
  • 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 (AUC0-96 hr) of ELITEK vs allopurinol1

Pediatric clinical trial design1*

Study 1: Randomized, multicenter, open-label, controlled study comparing efficacy of ELITEK vs allopurinol (N=52) administered 4 to 48 hours prior to anticancer therapy Study 1: Randomized, multicenter, open-label, controlled study comparing efficacy of ELITEK vs allopurinol (N=52) administered 4 to 48 hours prior to anticancer therapy

*Actual deviations from study protocol occurred in 2/52 patients (antitumor therapy given prior to first administration of ELITEK); presumed deviations from study protocol occurred in 1/52 patients (antitumor therapy was same as first administration of ELITEK or may have been prior to ELITEK administration).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 one course is not recommended.1

ALL=acute lymphocytic leukemia; ECOG=Eastern Cooperative Oncology Group; NHL=non-Hodgkin lymphoma.

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 Ill
  • 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 ≤3.3

Patients were stratified based on risk levels defined as3:

Patients were stratified by high, intermediate, and low risk Patients were stratified by high, intermediate, and low risk

*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 hyperuricemia1,3
  • 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 design1,3*

Study 2: ELITEK studied in 107 mostly pediatric patients when administered 4 to 48 hours prior to anticancer therapy in a multicenter, single-arm study Study 2: ELITEK studied in 107 mostly pediatric patients when administered 4 to 48 hours prior to anticancer therapy in a multicenter, single-arm study

*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 one course is not recommended.1

ALL=acute lymphocytic leukemia; ECOG=Eastern Cooperative Oncology Group; LDH=lactate dehydrogenase; NHL=non-Hodgkin lymphoma; ULN=upper limit of normal; WBC=white blood cell.

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 Ill
  • B-cell leukemia (of Burkitt type) with L3 morphology 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 ≤3.3

Patients were stratified based on risk levels defined as3:

Patients were stratified by high, intermediate, and low risk Patients were stratified by high, intermediate, and low risk

*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 hyperuricemia1,3
  • 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 design1,3*

Study 3: ELITEK studied in 131 mostly pediatric patients when administered 4 to 48 hours prior to anticancer therapy in a multicenter, single-arm study Study 3: ELITEK studied in 131 mostly pediatric patients when administered 4 to 48 hours prior to anticancer therapy in a multicenter, single-arm study

*Actual 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 one course is not recommended.1

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

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 pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection.
  • Among the 347 (265 pediatric; 82 adult) patients for whom all adverse reactions (ARs) regardless of severity were assessed in Studies 1, 2 and 3, as well as an uncontrolled safety trial, the most common ARs (≥10%) were vomiting (50%), fever (46%), nausea (27%), headache (26%), abdominal pain (20%), constipation (20%), diarrhea (20%), mucositis (15%), and rash (13%).
  • Among the 275 adult patients in Study 4, hypersensitivity reactions occurred in 4.3% of patients treated with ELITEK alone and 1.1% of patients treated with the ELITEK plus oral allopurinol. Hypersensitivity reactions included arthralgia, injection site irritation, peripheral edema, and rash. The most common Grade 3‐4 ARs regardless of relationship to study drug in Study 4 (ELITEK alone; ELITEK plus oral allopurinol; oral allopurinol alone) were sepsis (5.4%; 6.5%; 4.4%), hypophosphatemia (4.3%; 6.5%; 6.6%), anxiety (3.3%; 0%; 0%), abdominal pain (3.3%; 4.3%; 2.2%), hyperbilirubinemia (3.3%; 2.2%; 4.4%), and increased alanine aminotransferase (3.3%; 4.3%; 2.2%), respectively.
  • The following serious ARs occurred with a difference in incidence of ≥2% in patients receiving ELITEK vs. oral allopurinol in Study 1 and Study 4: pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections.

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