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Elitek^® is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ELITEK is indicated only for a single course of treatment.

ELITEK (rasburicase) Safety

Among the 347 (265 pediatric; 82 adult) patients for whom all adverse reactions regardless of severity were assessed in Studies 1, 2 and 3, as well as an uncontrolled safety trial, the most frequently observed adverse reactions (incidence ≥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/oral allopurinol combination. Hypersensitivity reactions included arthralgia, injection site irritation, peripheral edema, and rash.

The following serious adverse reactions occurred with a difference in incidence of greater than or equal to 2% in patients receiving ELITEK compared to patients receiving oral allopurinol in randomized studies (Study 1 and Study 4): pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorder, and abdominal and gastrointestinal infections.

Important Safety Information for ELITEK (rasburicase)

*Events were reported and graded according to NCI-CTC Version 3.0 and presented as preferred terms MedDRA version 10.1. Overall incidence ≥10% in any ELITEK arm and the difference between any ELITEK arm versus the allopurinol arm ≥5%.

• The incidence of anaphylaxis hemolysis and methemoglobinemia was <1% of the 887 ELITEK-treated patients enrolled in these clinical trials¹
• The following serious adverse reactions occurred at a difference in incidence of ≥2% in patients receiving ELITEK (rasburicase) compared to patients receiving allopurinol in randomized studies: pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections¹

No dose reductions required

• No studies of interactions with other drugs have been conducted in humans¹
• ELITEK (rasburicase) does not metabolize the following agents in vitro¹

  Allopurinol	Methotrexate	Cytarabine	6-Mercaptopurine
  Daunorubicin	Methylprednisolone	Thioguanine	Cyclophosphamide
  Vincristine	Etoposide

No metabolic-based drug interactions are therefore anticipated with the above agents in patients¹

• ELITEK (rasburicase) does not affect the activity of cytochrome P450 enzymes (CYP1A, CYP2A, CYP2B, CYP2C, CYP2E, and CYP3A) in vivo¹
  • Suggesting no induction or inhibition potential
  • Clinically relevant P450-mediated drug-drug interactions are therefore not anticipated in patients based on the recommended dosing schedule

Anaphylaxis: ELITEK can cause severe 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.