Important Safety Information for ELITEK (rasburicase)
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
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
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 the 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
most common Grade 3 or 4 adverse reactions regardless of relationship to study drug
in the 3 arms of Study 4 (ELITEK alone; ELITEK combined with 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 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 disorders, and abdominal and gastrointestinal infections.
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. ELITEK is indicated only
for a single course of treatment.
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