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Elitek (rasburicase) ® 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 anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.
DOSAGE AND ADMINISTRATION
The recommended dose of Elitek (rasburicase) is 0.2 mg/kg as a 30 minute intravenous infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than one course is not recommended.
- Elitek (rasburicase) must be reconstituted with the diluent provided in the carton.
- Reconstitute the 1.5 mg vial of Elitek (rasburicase) with 1 mL of diluent. Reconstitute the 7.5 mg vial of Elitek (rasburicase) with 5 mL of diluent. Mix by swirling gently. Do not shake or vortex.
- Inspect reconstituted Elitek (rasburicase) visually for particulate matter and discoloration prior to administration. Discard solution if particulate matter is visible or product is discolored.
Further Dilution and Administration
- Do not administer Elitek (rasburicase) as a bolus injection.
- Inject the calculated dose of reconstituted Elitek (rasburicase) solution into an infusion bag containing the appropriate volume of 0.9% sterile sodium chloride, to achieve a final total volume of 50 mL.
- Infuse over 30 minutes through a separate line or flush line with at least 15 mL of normal saline prior to and after Elitek (rasburicase) infusion.
- Do not use filters during reconstitution or infusion of Elitek (rasburicase) .
- Store reconstituted or diluted solution at 2-8°C.
- Discard unused product solution 24 hours following reconstitution.
Dosage Forms And Strengths
- 1.5 mg powder per single-use vial
- 7.5 mg powder per single-use vial
NDC 0024-5150-10: One carton contains 3 single-use vials each containing 1.5 mg of rasburicase and 3 ampules each containing 1 mL diluent.
NDC 0024-5151-75: One carton contains 1 single-use vial containing 7.5 mg of rasburicase and 1 ampule containing 5 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.
Manufactured by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807.
Last reviewed on RxList: 11/2/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Elitek Information
Report Problems to the Food and Drug Administration
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