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Elitek (Rasburicase) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Elitek ® 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.

Limitation of use: Elitek is indicated only for a single course of treatment [see Warnings and Precautions].

DOSAGE AND ADMINISTRATION

Dosage

The recommended dose of Elitek 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.

Reconstitution Procedure

  • Elitek must be reconstituted with the diluent provided in the carton.
  • Reconstitute the 1.5 mg vial of Elitek with 1 mL of diluent. Reconstitute the 7.5 mg vial of Elitek with 5 mL of diluent. Mix by swirling gently. Do not shake or vortex.
  • Inspect reconstituted Elitek 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 as a bolus injection.
  • Inject the calculated dose of reconstituted Elitek 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 infusion.
  • Do not use filters during reconstitution or infusion of Elitek.
  • 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

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

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.

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