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For U.S. Healthcare Professionals Only

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PREPARATION & ADMINISTRATION

ELITEK is available in 2 vial sizes: 1.5 mg and 7.5 mg1

3 single-dose vials

ELITEK 1.5 mgNDC# 0024-5150-10

3 single-dose vials each containing 1.5 mg of ELITEK and 3 ampules each containing 1 mL diluent

1 single-dose vial

ELITEK 7.5 mg NDC# 0024-5151-75

1 single-dose vial containing 7.5 mg of ELITEK and 1 ampule containing 5 mL diluent

Reconstituting ELITEK

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
30-minute IV infusion

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 ELITEK

Storing ELITEK

  • 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

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 

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