Jane S. Ricciuti, RPh, MS

Disclosures

September 20, 2002

In This Article

Biologics

Elitek
(rasburicase) Injection

Manufacturer: Sanofi-Synthelabo, Inc

Drug Approval Classification: Biologics license application (Approval Date: 7/12/02)

Indication: Elitek (rasburicase) is indicated for the initial management of plasma uric acid levels in pediatric 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.

Dosing: Elitek is dosed starting at 0.15 or 0.20 mg/kg as a single daily dose for 5 days. Dosing beyond 5 days or administration of more than 1 course of Elitek is not recommended. Chemotherapy should be initiated 4 to 24 hours after the first dose of Elitek. DO NOT ADMINISTER AS A BOLUS INFUSION. Elitek should be administered as an intravenous infusion over 30 minutes.

Clinical Summary: Rasburicase is a recombinant urate-oxidase enzyme. Rasburicase catalyzes enzymatic oxidation of uric acid into an inactive and soluble metabolite (allantoin).

The Elitek labeling contains a Black Box warning that includes warnings for rasburicase-associated anaphylaxis, hemolysis, methemoglobinemia, and interference with uric acid measurements. Severe hemolysis can occur in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency; patients with G6PD deficiency should be screened prior to starting rasburicase.

Three clinical studies evaluated the safety and efficacy of Elitek in 265 patients, primarily pediatric patients, with acute leukemia or non-Hodgkin's lymphoma. A pooled analysis of the clinical trials showed that patients treated with Elitek maintained their prechemotherapy plasma uric acid levels.

Adverse Effects: The incidence of allergic reactions with Elitek included anaphylaxis (< 1%), rash (1%), hemolysis (< 1%), and methemoglobinemia (< 1%). Serious adverse effects included fever (5%), neutropenia with fever (4%), respiratory distress (3%), sepsis (3%), neutropenia (2%), and mucositis (2%).

Pharmacokinetics: No drug-drug interaction studies were conducted with rasburicase.

Elitek (rasburicase) Labeling

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