ELITEK

The pharmacokinetics of rasburicase was evaluated in both pediatric and adult patients with leukemia, lymphoma or other hematological malignancies. Rasburicase exposure, as measured by AUC 0–24 hr and C max , tended to increase with a dose range from 0.15 to 0.2 mg/kg. The mean terminal half-life was similar between pediatric and adult patients and ranged from 15.7 to 22.5 hours. The mean volume of distribution of rasburicase ranged from 110 to 127 mL/kg in pediatric patients and from 75.8 to 13...

14.1 Pediatrics Elitek was administered in three studies to 265 patients with acute leukemia or non-Hodgkin's lymphoma. These clinical studies were largely limited to pediatric patients (246 of 265). Elitek was administered as a 30-minute infusion once (n=251) or twice (n=14) daily at a dose of 0.15 or 0.2 mg/kg/dose (total daily dose 0.2–0.4 mg/kg/day). Elitek was administered prior to and concurrent with antitumor therapy, which consisted of either systemic chemotherapy (n=196) or steroids (n=69).

Study 1Study 1 was a randomized, open-label, controlled study conducted at six institutions, i...

The following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information: Anaphylaxis [see Boxed Warning , Contraindications (4) , Warnings and Precautions (5.1) ] Hemolysis [see Boxed Warning , Contraindications (4) , Warnings and Precautions (5.2) ] Methemoglobinemia [see Boxed Warning , Contraindications (4) , Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥20%), when used concomitantly with anticancer t...

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 [see Boxed Warning , Warnings and Precautions (5.1 , 5.2 , 5.3) ] . Elitek is contraindicated in individuals deficient in glucose-6-phosphate dehydrogenase (G6PD) [see Boxed Warning , Warnings and ...

5.1 Hypersensitivity Reactions Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. In clinical studies, anaphylaxis was reported in <1% patients receiving Elitek. This can occur at any time during treatment including the first dose. Signs and symptoms of these reactions include bronchospasm, chest pain and tightness, dyspnea, hypoxia, hypotension, shock, and urticaria. Immediately and permanently discontinue Elitek administration in any patient developing clinica...

7 DRUG INTERACTIONS Laboratory Test Interference At room temperature, Elitek causes enzymatic degradation of the uric acid in blood/plasma/serum samples potentially resulting in spuriously low plasma uric acid assay readings. The following special sample handling procedure must be followed to avoid ex vivo uric acid degradation. Uric acid must be analyzed in plasma. Blood must be collected into pr...