Indication
ELITEK is indicated for the initial management of plasma uric acid levels in 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. ELITEK is indicated only for a single course of treatment.
9 out of 10
adult patients were at high risk at baseline
82%
of adult patients had normal uric acid levels (≤7.5 mg/dL) at baseline
Adult patients meeting at least 1 of the following criteria were enrolled in the pivotal trial1:
HIGH RISK1-3
Aggressive lymphoma/leukemia (defined by REAL)
AML
Elevated plasma uric acid levels (>7.5 mg/dL) at baseline
High-grade MDS with >10% bone marrow blast involvement
CML in blast crisis
INTERMEDIATE (POTENTIAL) RISK1
Aggressive lymphoma/leukemia, not limited to the REAL definition, with LDH ≥2x the upper limit of normal
Any stage III to IV lymphoma or leukemia
Stage I or II disease with bulky lymph node/tumor (>5 cm) involvement
AML=acute myeloid leukemia; CLL=chronic lymphocytic leukemia; CML=chronic myeloid leukemia; DLBCL=diffuse large B-cell lymphoma; MDS=myelodysplastic syndrome; REAL=Revised European American Classification of Lymphoid Neoplasms.
WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS
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
Please see full Prescribing Information including Boxed WARNING.