ELITEK® (rasburicase) IV Infusion

EXPLORE CLINICAL DATA

In a phase 3 trial, ELITEK given prophylactically (prior to anticancer therapy) maintained normal uric acid levels (≤7.5 mg/dL) in significantly more patients (87%, n=92) vs allopurinol (66%, n=91) between 3 and 7 days after initiation of antihyperuricemic treatment (P=0.001) (primary endpoint).¹

EXPLORE RESOURCES

Mechanism of Action

See how ELITEK functions differently than allopurinol

EXPLORE ELITEK MOA

Identify Patients at Risk

Know what to look for in your patients

SEE TLS RISK FACTORS

Reference: 1. Cortes J, Moore JO, Maziarz RT, et al. Control of plasma uric acid in adults at risk for tumor lysis syndrome: efficacy and safety of rasburicase alone and rasburicase followed by allopurinol compared with allopurinol alone—results of a multicenter phase III study. J Clin Oncol. 2010;28(27):4207-4213.

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.

Contraindictions

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

Indication

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 anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.

Limitation of use: ELITEK is indicated only for a single course of treatment.

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In Patients at Risk of Tumor Lysis Syndrome (TLS) Associated With Hyperuricemia, the Power to Prevent Rising Uric Acid Levels is in Your Hands With Elitek® (rasburicase) IV Infusion

Mechanism of Action

Identify Patients at Risk

Important Safety Information

Contraindictions

Adverse Reactions

Use in Specific Populations

Indication

Important Safety Information

Indication

In Patients at Risk of Tumor Lysis Syndrome (TLS) Associated With Hyperuricemia, the Power to Prevent Rising Uric Acid Levels is in Your Hands With Elitek^®(rasburicase) IV Infusion