ELITEK^® (rasburicase) IV Infusion Has a Proven Safety Profile

Overall incidence of adverse reactions ≥10% in any ELITEK arm and the difference between any ELITEK arm vs the allopurinol arm ≥5%.¹

*Events were reported and graded according to NCI-CTC Version 3.0 and presented as preferred terms MedDRA version 10.1.¹

ALT=alanine aminotransferase; NCI-CTC=National Cancer Institute-Common Terminology Criteria.

• 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 these clinical trials¹

Adverse Reactions for Studies 1, 2 and 3.

• Adverse Reactions in Pediatric Patients: The safety of Elitek was assessed in 347 patients comprising 265 children and 82 adults from Studies 1, 2, 3 and an uncontrolled safety trial. The most frequently observed (incidence ≥10%) adverse reactions regardless of severity were vomiting (50%), fever (46%), nausea (27%), headache (26%), abdominal pain (20%), constipation (20%), diarrhea (20%), mucositis (15%), and rash (13%). In Study 1, an active control study, the following adverse reactions occurred more frequently in Elitek-treated subjects than allopurinol-treated subjects: vomiting, fever, nausea, diarrhea, and headache.
  Although the incidence of rash was similar in the two arms, severe rash was reported only in one Elitek-treated patient.