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For U.S. Healthcare Professionals Only

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PROTECT PEDIATRIC PATIENTS AT RISK FROM RISING URIC ACID LEVELS

  • 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

100% of patients achieved normal uric acid levels with ELITEK regardless of baseline uric acid levels 100% of patients achieved normal uric acid levels with ELITEK regardless of baseline uric acid levels
  • 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

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 (± s.e.) plasma uric acid concentrations over time for all patients2

Pediatric patients receiving ELITEK experienced a more rapid decline vs allopurinol (P<0.0001) and maintained normal uric acid levels throughout treatment 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 in Study 1

Primary endpoint

  • The uric acid AUC0-96 hr was significantly lower in the ELITEK group (128 ± s.e. 14 mg hr/dL) vs the allopurinol group (328 ± s.e. 26 mg hr/dL)1

All but one 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 two study arms; one 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 one 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

99% (106/107) of pediatric patients in Study 2 maintained 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 agents 99% (106/107) of pediatric patients in Study 2 maintained 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 agents

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 one 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

92% (n=12) and 95% (n=119) of pediatric patients in Study 3 maintained 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 agents 92% (n=12) and 95% (n=119) of pediatric patients in Study 3 maintained 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 agents

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 one course is not recommended.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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