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ELITEK® (rasburicase) IV Infusion Has a Proven Safety Profile

Per-patient incidence of selected adverse reactions in adults (Study 4)1

A three columned table showing per-patient incidence percentage of selected adverse reaction in adults (Study 4) for ELITEK (n=92) with Adverse reactions in order of All Grades then Grades 3/4 for the following: Nausea 57.6 to 1.1, Peripheral edema 50 to 2.2, Vomiting 38 to 1.1, Anxiety 23.9 to 3.3, Abdominal pain 21.7 to 3.3, Hypophosphatemia 17.4 to 4.3, Hyperbilirubinemia 16.3 to 3.3, Pharyngolaryngeal pain 14.1 to 1.1, Sepsis 12 to 5.4, Fluid overload 12 to 0, Increased ALT 10.9 to 3.3, Hyperphoshatemia 9.8 to 0
A three columned table showing per-patient incidence percentage of selected adverse reaction in adults (Study 4) for ELITEK + allopurinal (n=92) with Adverse reactions in order of All Grades then Grades 3/4 for the following: Nausea 60.9 to 1.1, Peripheral edema 43.5 to 3.3, Vomiting 37 to 0, Anxiety 17.4 to 0, Abdominal pain 33.7 to 4.3, Hypophosphatemia 22.8 to 6.5, Hyperbilirubinemia 14.1 to 2.2, Pharyngolaryngeal pain 14.1 to 2.2, Sepsis 7.6 to 6.5, Fluid overload 6.5 to 0, Increased ALT 27.2 to 4.3, Hyperphoshatemia 15.2 to 0.
A three columned table showing per-patient incidence percentage of selected adverse reaction in adults (Study 4) for allopurinol (n=91) with Adverse reactions in order of All Grades then Grades 3/4 for the following: Nausea 54.9 to 2.2, Peripheral edema 42.9 to 6.6, Vomiting 30.8 to 1.1, Anxiety 17.6 to 0, Abdominal pain 25.3 to 2.2, Hypophosphatemia 16.5 to 6.6, Hyperbilirubinemia 16.5 to 6.6, Pharyngolaryngeal pain 9.9 to 0, Sepsis 4.4 to 4.4, Fluid overload 3.3 to 1.1, Increased ALT 17.6 to 2.2, Hyperphoshatemia 8.8 to 1.

Overall incidence of adverse reactions ≥10% in any ELITEK arm and the difference between any ELITEK arm vs the allopurinol arm ≥5%.1

*Events were reported and graded according to NCI-CTC Version 3.0 and presented as preferred terms MedDRA version 10.1.1

ALT=alanine aminotransferase; NCI-CTC=National Cancer Institute-Common Terminology Criteria.

  • Hypersensitivity reactions occurred in 4.3% of ELITEK-treated patients and 1.1% of ELITEK/allopurinol-treated patients in Study 4. Clinical manifestations of hypersensitivity included arthralgia, injection site irritation, peripheral edema, and rash1
  • The following serious adverse reactions occurred at a difference in incidence of ≥2% in patients receiving ELITEK compared to patients receiving allopurinol in randomized studies (Study 1 and Study 4): pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections1
  • The incidence of anaphylaxis, hemolysis, and methemoglobinemia was less than 1% of the 887 ELITEK-treated patients entered on these clinical trials1

Clinician's Guide

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

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.

Contraindictions

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

Indication

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 anticancer 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.

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Important Safety Information

Indication

ELITEK and Sanofi are registered trademarks of Sanofi or an affiliate. All the other trademarks above are the property of their respective owners, who have no affiliation or relationship with Sanofi. MAT-US-2020413-v3.0-03/2025

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