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PROTECT ADULT PATIENTS AT HIGH RISK FROM RISING URIC ACID LEVELS

ELITEK given prophylactically maintained normal uric acid levels in significantly more high-risk adult patients vs allopurinol1

High-risk adult patients (%) who maintained normal uric acid levels (7.5 mg/dL)1,2

ELITEK given prophylactically maintained normal uric acid levels (≤7.5 mg/dL) in 89% of high-risk patients vs 68% with allopurinol ELITEK given prophylactically maintained normal uric acid levels (≤7.5 mg/dL) in 89% of high-risk patients vs 68% with allopurinol

Primary endpoint

  • Results were consistent with the overall study population of intermediate and high-risk adult patients: 87% (n=92) of all patients receiving ELITEK prophylactically maintained uric acid levels ≤7.5 mg/dL vs 66% (n=91) of patients receiving allopurinol (P=0.001)1
    • ELITEK + allopurinol maintained normal uric acid in 78% (n=92) of patients (P=NS vs allopurinol)1

ELITEK is recommended for patients at high and intermediate (potential) risk for development of TLS associated with hyperuricemia3

Unlike allopurinol, ELITEK maintained normal uric acid levels in 100% of assessable adult patients4

Documented failure rate in hyperuricemic and nonhyperuricemic adult patients4

Documented failure rates were 0% for ELITEK, 0% for ELITEK + allopurinol, and 11% for allopurinol Documented failure rates were 0% for ELITEK, 0% for ELITEK + allopurinol, and 11% for allopurinol

No adult patients receiving ELITEK alone required antihyperuricemic treatment past 5 days4

Percentage of adult patients extended beyond 5 days of treatment4

0% of ELITEK patients required treatment beyond 5 days vs 4.4% with allopurinol 0% of ELITEK patients required treatment beyond 5 days vs 4.4% with allopurinol

ELITEK given prophylactically maintained normal uric acid levels in significantly more adult patients with baseline hyperuricemia vs allopurinol1

  • 18% of adult patients (n=275) were hyperuricemic (>7.5 mg/dL) at baseline and therefore considered at high risk of developing TLS1

Hyperuricemic adult patients (%) who maintained normal uric acid levels (7.5 mg/dL)1,2

ELITEK maintained normal uric acid levels (≤7.5 mg/dL) in 90% of hyperuricemic patients vs 53% with allopurinol ELITEK maintained normal uric acid levels (≤7.5 mg/dL) in 90% of hyperuricemic patients vs 53% with allopurinol

Primary endpoint

  • Results were consistent with the overall study population of intermediate and high-risk adult patients: 87% (n=92) of all patients receiving ELITEK prophylactically maintained uric acid levels ≤7.5 mg/dL vs 66% (n=91) of patients receiving allopurinol (P=0.001)1
    • ELITEK + allopurinol maintained normal uric acid in 78% (n=92) of patients (P=NS vs allopurinol)1

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for CLL/SLL: Consider prophylaxis with rasburicase in patients receiving venetoclax with high tumor burden and elevated baseline uric acid5

CLL=chronic lymphocytic leukemia; SLL=small lymphocytic lymphoma.

ELITEK given prophylactically significantly and rapidly lowered uric acid levels1,4

96% of ELITEK adult patients (n=275) achieved uric acid levels ≤2 mg/dL within 4 hours after their first dose vs 0% with allopurinol1,4

Reduction in uric acid levels1,4

ELITEK given prophylactically reduced uric acid levels rapidly and significantly 4 hours after the first dose ELITEK given prophylactically reduced uric acid levels rapidly and significantly 4 hours after the first dose

*Plasma uric acid AUC from Day 1 through Day 7 was significantly lower for ELITEK and ELITEK + allopurinol than for allopurinol alone (P<0.001).1

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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