ELITEK is indicated for the initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.

The recommended dose and schedule of ELITEK is 0.15 or 0.20 mg/kg as a single daily dose for 5 days. Because the safety and effectiveness of other schedules have not been established, dosing beyond 5 days or administration of more than one 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.

Reconstitution Procedure

Determine the number of vials of ELITEK needed to achieve the proper dosage, based on the individual patient†s weight and the dose per kilogram. ELITEK must be reconstituted in the diluent provided. Add 1 mL of the provided reconstitution solution (diluent) to each vial of ELITEK and mix by swirling very gently. Do not shake or vortex. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, and discarded if particulate matter is visible or if product is discolored.

Further Dilution and Administration

Using aseptic technique and syringes of appropriate volume, remove the predetermined dose of ELITEK from the reconstituted vials and inject into an infusion bag containing the appropriate volume of 0.9% sterile sodium chloride, to achieve a final total volume of 50 mL. This final solution for injection is to be infused over 30 minutes. No filters should be used for the infusion.

The reconstituted ELITEK contains no preservatives and must be administered within 24 hours of reconstitution. The reconstituted or diluted solution can be stored up to 24 hours at 2-8°C. Discard any unused product.

ELITEK should be infused through a different line than that used for the infusion of other concomitant medications. If use of a separate line is not possible, the line should be flushed with at least 15 mL of saline solution prior to and after infusion with ELITEK.

NDC 0024-5150-10: One carton containing 3 single-use vials each containing 1.5 mg of rasburicase and 3 ampules each containing 1.0 mL diluent.

Storage and Handling

The lyophilized drug product and the diluent for reconstitution should be stored at 2-8°C (36-46°F). Do not freeze. Protect from light.

References

1. Goldman SC, Holcenberg JS, Finklestein JZ. A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis. Blood. 2001;97:2998-3003.
2. Pui C-H, Mahmoud HH, Wiley JM et al. Recombinant urate oxidase for the prophylaxis or treatment of hyperuricemia in patients with leukemia or lymphoma. J Clin Oncol. 2001;19:697-704.
3. National Cancer Institute Common Toxicity Criteria, Version 2.0 (http://ctep.cancer.gov/reporting/ctc.html).

Manufactured and distributed by Sanofi-Synthelabo Inc.
New York, NY 10016
U.S. License No. 1294

ESS-4A

Revised Dec. 2004

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