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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 pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection.
  • Among the 347 (265 pediatric; 82 adult) patients for whom all adverse reactions (ARs) regardless of severity were assessed in Studies 1, 2 and 3, as well as an uncontrolled safety trial, the most common ARs (≥10%) were vomiting (50%), fever (46%), nausea (27%), headache (26%), abdominal pain (20%), constipation (20%), diarrhea (20%), mucositis (15%), and rash (13%).
  • Among the 275 adult patients in Study 4, hypersensitivity reactions occurred in 4.3% of patients treated with ELITEK alone and 1.1% of patients treated with the ELITEK plus oral allopurinol. Hypersensitivity reactions included arthralgia, injection site irritation, peripheral edema, and rash. The most common Grade 3‐4 ARs regardless of relationship to study drug in Study 4 (ELITEK alone; ELITEK plus oral allopurinol; oral allopurinol alone) were sepsis (5.4%; 6.5%; 4.4%), hypophosphatemia (4.3%; 6.5%; 6.6%), anxiety (3.3%; 0%; 0%), abdominal pain (3.3%; 4.3%; 2.2%), hyperbilirubinemia (3.3%; 2.2%; 4.4%), and increased alanine aminotransferase (3.3%; 4.3%; 2.2%), respectively.
  • The following serious ARs occurred with a difference in incidence of ≥2% in patients receiving ELITEK vs. oral allopurinol in Study 1 and Study 4: pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections.

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