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ELITEK HAS A PROVEN SAFETY PROFILE

Per-patient incidence of selected adverse reactions in Study 41

ELITEK %
(n=92)
Adverse Reaction* All Grades Grades 3/4
Nausea 57.6 1.1
Peripheral edema 50 2.2
Vomiting 38 1.1
Anxiety 23.9 3.3
Abdominal pain 21.7 3.3
Hypophosphatemia 17.4 4.3
Hyperbilirubinemia 16.3 3.3
Pharyngolaryngeal pain 14.1 1.1
Sepsis 12 5.4
Fluid overload 12 0
Increased ALT 10.9 3.3
Hyperphosphatemia 9.8 0
ELITEK + allopurinol %
(n=92)
Adverse Reaction* All Grades Grades 3/4
Nausea 60.9 1.1
Peripheral edema 43.5 3.3
Vomiting 37 0
Anxiety 17.4 0
Abdominal pain 33.7 4.3
Hypophosphatemia 22.8 6.5
Hyperbilirubinemia 14.1 2.2
Pharyngolaryngeal pain 20.7 0
Sepsis 7.6 6.5
Fluid overload 6.5 0
Increased ALT 27.2 4.3
Hyperphosphatemia 15.2 0
allopurinol %
(n=91)
Adverse Reaction* All Grades Grades 3/4
Nausea 54.9 2.2
Peripheral edema 42.9 6.6
Vomiting 30.8 1.1
Anxiety 17.6 0
Abdominal pain 25.3 2.2
Hypophosphatemia 16.5 6.6
Hyperbilirubinemia 7.7 4.4
Pharyngolaryngeal pain 9.9 0
Sepsis 4.4 4.4
Fluid overload 3.3 1.1
Increased ALT 17.6 2.2
Hyperphosphatemia 8.8 1.1

Overall incidence of adverse reactions ≥10% in any ELITEK arm and the difference between any ELITEK arm vs allopurinol ≥5%.1

*Events were reported and graded according to NCI-CTC Version 3.0 and presented as preferred terms MedDRA version 10.1.1

  • Hypersensitivity reactions occurred in 4.3% of ELITEK-treated patients and 1.1% of ELITEK/allopurinol-treated patients in Study 4. Clinical manifestations of hypersensitivity included arthralgia, injection site irritation, peripheral edema, and rash1
  • The following serious adverse reactions occurred at a difference in incidence of ≥2% in patients receiving ELITEK compared to patients receiving allopurinol in randomized studies (Study 1 and Study 4): pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections1
  • The incidence of anaphylaxis, hemolysis, and methemoglobinemia was less than 1% of the 887 ELITEK-treated patients entered on the clinical trials1

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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