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For U.S. Healthcare Professionals Only

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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 prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection.

CONTRAINDICATIONS
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 

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