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Prescribing information
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ELITEK® (rasburicase):
once daily for up to 5 days

Recommended ELITEK dosing: 0.2 mg/kg once daily1

  • 30-minute intravenous infusion
  • For up to 5 days
  • No dose-modification requirement
  • Not indicated for dosing beyond 5 days or administration of more than 1 course
  • Do not administer as an intravenous bolus

How to prepare ELITEK1

  • ELITEK must be reconstituted with the diluent provided in the carton
    • Reconstitute the 1.5-mg vial of ELITEK with 1 mL of diluent OR
    • Reconstitute the 7.5-mg vial of ELITEK with 5 mL of diluent
  • Mix by swirling gently. Do not shake or vortex
  • Inspect the vial of ELITEK and the diluent before administration, and discard if particulate matter or discoloration is visible

How to administer ELITEK in all patients1

  • Administer ELITEK as an intravenous infusion only
  • 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. DO NOT use filters during infusion of reconstituted ELITEK drug product
  • Infuse over 30 minutes through a separate IV line or flush line with at least 15 mL of normal saline prior to and after ELITEK infusion

Storing ELITEK1

  • Store reconstituted or diluted solution at 2°C-8°C (36°F-46°F)
  • Discard unused product solution 24 hours following reconstitution
  • The lyophilized drug product and the diluent for reconstitution should be stored at 2°C-8°C (36°F-46°F)
  • Do not freeze
  • Protect from light
Product Information Sheet

Refer to this sheet to see how ELITEK is supplied

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Reference: 1. ELITEK [prescribing information]. Bridgewater, NJ: sanofi-aventis U.S. LLC.

INDICATION

ELITEK is indicated for the initial management of plasma uric acid levels in 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. ELITEK is indicated only for a single course of treatment.

IMPORTANT SAFETY INFORMATION

WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS

  • Hypersensitivity Reactions: ELITEK can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue ELITEK in patients who experience a serious hypersensitivity reaction.
  • Hemolysis: Do not administer ELITEK to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue ELITEK in patients developing hemolysis. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting ELITEK.
  • Methemoglobinemia: ELITEK can result in methemoglobinemia in some patients. Immediately and permanently discontinue ELITEK in patients developing methemoglobinemia.
  • Interference with Uric Acid Measurements: ELITEK enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection.

CONTRAINDICATIONS

ELITEK is contraindicated in patients with a history of anaphylaxis or severe hypersensitivity to rasburicase or in patients with development of hemolytic reactions or methemoglobinemia with rasburicase. ELITEK is contraindicated in individuals deficient in glucose-6-phosphate dehydrogenase (G6PD).

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥20%), when used concomitantly with anticancer therapy, are vomiting, nausea, fever, peripheral edema, anxiety, headache, abdominal pain, constipation, diarrhea, hypophosphatemia, pharyngolaryngeal pain, and increased alanine aminotransferase.

USE IN SPECIFIC POPULATIONS
  • Pregnancy: Consider the benefits and risks of ELITEK and possible risks to the fetus when prescribing ELITEK to a pregnant woman
  • Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with ELITEK and for 2 weeks after the last dose

Please see full Prescribing Information, including Boxed WARNING.

MAT-US-2020414-v2.0-08/2022
Last Updated: August 2022-08-01YYYY