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Protect against rising uric acid levels in high-risk adult patients

A head-to-head trial vs allopurinol demonstrated superior efficacy in maintaining normal uric acid levels1

Proportion of patients with normal uric acid levels ≤7.5 mg/dL from Day 3 to Day 7 after initiating antihyperuricemic treatment (primary endpoint)1

Percentage of adult patients with uric acid levels (≤7.5 mg/dL) from day 3 to day 7 after initiating antihyperuricemic treatment: 87% with ELITEK (n=92); 78% with ELITEK and allopurinol (n=92) (P=0.001); 66% with allopurinol (n=91) (P=0.06).

Unlike allopurinol, ELITEK® (rasburicase) IV Infusion maintained normal uric acid levels in 100% of assessable adult patients2

Documented failure rate in hyperuricemic and nonhyperuricemic adult patients2

Three boxes showing Elitek 0% (n=92), Elitek + allopurinol 0% (n=92), allopurinol 11% (n=91).
  • The ELITEK, ELITEK + allopurinol, and allopurinol arms had 13%, 15%, and 19% missing uric acid samples, respectively. The uric acid failure status in those patients is unknown2

No adult patients receiving ELITEK alone required antihyperuricemic treatment past 5 days2

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ELITEK given prophylactically maintained normal uric acid levels in significantly more high-risk adult patients vs allopurinol1

High-risk adult patients (%) who maintained normal uric acid levels (≤7.5 mg/dL)1

 

Percentage of high-risk adult patients with uric acid levels (≤7.5 mg/dL) from day 3 to day 7 after initiating antihyperuricemic treatment: 89% with ELITEK (n=82) (P=0.001); 79% with ELITEK and allopurinol (n=86) (P=0.001); 68% with allopurinol (n=85) (P=0.1).
ELITEK is recommended for patients at high and intermediate (potential) risk for development of tumor lysis syndrome (TLS) associated with hyperuricemia3

   

ELITEK given prophylactically maintained normal uric acid levels in significantly more adult patients with baseline hyperuricemia vs allopurinol1

  • 18% of adult patients (n=275) were hyperuricemic (≥7.5 mg/dL) at baseline and therefore considered at high risk of developing TLS1

Hyperuricemic adult patients (%) who maintained normal uric acid levels (≤7.5 mg/dL)1

Percentage of hyperuricemic adult patients with uric acid levels (≤7.5 mg/dL) from day 3 to day 7 after initiating antihyperuricemic treatment: 90% with ELITEK (n=19) (P=0.015); 77% with ELITEK and allopurinol (n=13) (P=0.015); 53% with allopurinol (n=17) (P=0.2).

Primary endpoint

  • Results were consistent with the overall study population of intermediate and high-risk adult patients: 87% (n=92) of all patients receiving ELITEK prophylactically maintained uric acid levels ≤7.5 mg/dL vs 66% (n=91) of patients receiving allopurinol (P=0.001)1
    • ELITEK + allopurinol maintained normal uric acid in 78% (n=92) of patients (P=NS vs allopurinol)1

    
 

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for CLL/SLL: Consider prophylaxis with rasburicase in patients receiving venetoclax with high tumor burden and elevated baseline uric acid4

Guideline notes consideration for comorbidities before final determination of prophylaxis and dosing schedule.4

 Please refer to venetoclax package insert for additional management considerations. 

    
   

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CLL=chronic lymphocytic leukemia; DLBCL=diffuse large B-cell lymphoma; SLL=small lymphocytic lymphoma.

References: 1. Cortes J, Moore JO, Maziarz RT, et al. Control of plasma uric acid in adults at risk for tumor lysis syndrome: efficacy and safety of rasburicase alone and rasburicase followed by allopurinol compared with allopurinol alone—results of a multicenter phase III study. J Clin Oncol. 2010;28(27):4207-4213. 2. ELITEK [prescribing information]. NJ: sanofi-aventis U.S. LLC. 3. Howard SC, Jones DP, Pui CH. The tumor lysis syndrome. N Engl J Med. 2011;364(19):1844-1854. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. V.2.2025. ©National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed March 22, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

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-2020411-v3.0-03/2025

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