August 24, 2016
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Elitek

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Elitek




Indications
Dosage
How Supplied

INDICATIONS

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.
    • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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.

HOW SUPPLIED

Dosage Forms And Strengths

  • For injection: 1.5 mg, lyophilized powder in single-dose vial for reconstitution
  • For injection: 7.5 mg, lyophilized powder in single-dose vial for reconstitution

How Supplied

NDC 0024-5150-10: One carton contains 3 single-dose 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-dose 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. Revised: June 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/28/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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