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TLS is caused by a massive release of intracellular contents into peripheral blood that results in metabolic derangements, including hyperuricemia, hyperkalemia, hyperphosphatemia, and hypocalcemia.1
TLS associated with hyperuricemia may lead to serious clinical complications, including acute renal failure, cardiac arrhythmias, loss of muscle control, seizures, or death.2

   

   

To diagnose TLS, test for 2 or more of the following abnormalities within 3 days before to 7 days after initiation of cancer treatment: uric acid ≥8 mg/dL or 25% increase from baseline; potassium ≥6 mEq/dL or 25% increase from baseline; phosphate ≥6.5 mg/dL (children), ≥4.5 mg/dL (adults), or 25% increase from baseline; calcium ≥25% decrease from baseline.3

   

   

In a retrospective analysis of 1198 patients with hematologic malignancies treated with inpatient chemotherapy, the risk of TLS increased with rising uric acid levels4:

  • Patients with high uric acid levels (>8.0 mg/dL) had an 85.7% risk of developing TLS. Compared to patients with medium uric acid levels (4.0-8.0 mg/dL), there was a relative risk increase of 3.7 (95% CI: 2.6-5.2), P<0.0014
  • Patients with medium uric acid levels (4.0-8.0 mg/dL) had a 23.4% risk of developing TLS. Compared to patients with low uric acid levels (<4.0 mg/dL), there was a relative risk increase of 5.5 (95% CI: 3-10), P<0.0014

   

   

There are a variety of factors that can put patients at risk of developing TLS. If your patients have hematologic malignancies, received certain anticancer agents associated with developing TLS, demonstrate rising uric acid levels, or have other factors such as an elevated white blood cell count or bulky disease, they may be at an increased risk for TLS.2,5-29

   

   

ELITEK is a recombinant urate-oxidase approved by the FDA for the initial management of 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. Limitations of Use: ELITEK is indicated only for a single course of treatment.30

   

ELITEK is a recombinant urate-oxidase that catalyzes enzymatic oxidation of poorly soluble uric acid into an inactive and more soluble metabolite (allantoin).30
Unlike allopurinol, ELITEK is the only antihyperuricemic agent that has the mechanism to clear existing uric acid.31

   

   

In a phase 3 trial comparing ELITEK and allopurinol in adults,* 18% of patients were hyperuricemic (>7.5 mg/dL) at baseline. ELITEK given prophylactically maintained normal uric acid levels (≤7.5 mg/dL) from Day 3 to Day 7 in 90% of patients with baseline hyperuricemia, while 53% of patients taking allopurinol maintained normal uric acid levels over the same time period (P=0.015).1

   

   

*ELITEK was studied in a randomized, multicenter, open-label, phase 3 study in adult patients (N=275) with leukemia, lymphoma, and solid tumor malignancies at risk for hyperuricemia and TLS. The primary endpoint for the pivotal study was the response rate, defined as the proportion of adult patients with plasma uric acid levels maintained at ≤7.5 mg/dL between 3 and 7 days after initiation of antihyperuricemic treatment.1,30
Results were consistent with the overall patient population (primary endpoint): 87% (n=92) of patients receiving ELITEK prophylactically maintained uric acid levels ≤7.5 mg/dL vs 66% (n=91) of patients receiving allopurinol (P=0.001). ELITEK + allopurinol maintained normal uric acid in 78% (n=92) of patients (P=NS vs allopurinol).1

   

In a phase 3 trial comparing ELITEK and allopurinol in adults,* 92% of patients were at high risk for TLS at baseline. ELITEK given prophylactically maintained normal uric acid levels (≤7.5 mg/dL) from Day 3 to Day 7 in 89% of high-risk patients, while 68% of patients taking allopurinol maintained normal uric acid levels over the same time period (P=0.001).1

   

   

*ELITEK was studied in a randomized, multicenter, open-label, phase 3 study in adult patients (N=275) with leukemia, lymphoma, and solid tumor malignancies at risk for hyperuricemia and TLS. The primary endpoint for the pivotal study was the response rate, defined as the proportion of adult patients with plasma uric acid levels maintained at ≤7.5 mg/dL between 3 and 7 days after initiation of antihyperuricemic treatment.1,30
Results were consistent with the overall patient population (primary endpoint): 87% (n=92) of patients receiving ELITEK prophylactically maintained uric acid levels ≤7.5 mg/dL vs 66% (n=91) of patients receiving allopurinol (P=0.001). ELITEK + allopurinol maintained normal uric acid in 78% (n=92) of patients (P=NS vs allopurinol).1

   

ELITEK is approved for use in pediatric patients. The safety and effectiveness of ELITEK have been established in pediatric patients ages 1 month to 17 years for 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.30,32

   

   

The recommended dose for ELITEK is 0.2 mg/kg once daily. ELITEK is not indicated for dosing beyond 5 days or administration of more than 1 course. Do not administer as an intravenous bolus.30
ELITEK is available in 2 vial sizes: 1.5 mg and 7.5 mg. 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.30

   

   

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. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas. V.2.2025. ©National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed March 24, 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 use in any way. 3. Edeani A, Shirali A. Chapter 4: Tumor Lysis Syndrome. Onco-Nephrology Curriculum. American Society of Nephrology. 2016. 4. Cairo MS. Prevention and treatment of hyperuricemia in hematological malignancies. Clin Lymphoma. 2002;3(S1)S26-S31. 5. Venclexta [prescribing information]. East Windsor, NJ: Acrotech Biopharma LLC; 2024. 6. Imbruvica [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; 2024. 7. Yescarta [prescribing information]. Santa Monica, CA: Kite Pharma, Inc; 2024. 8. Revlimid [prescribing information]. Summit, NJ: Celgene Corporation; 2023. 9. Bendeka [prescribing information]. Parsippany, NJ: Teva Pharmaceuticals; 2024. 10. Gleevec [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024. 11. Gazyva [prescribing information]. South San Francisco, CA: Genentech, Inc.; 2022. 12. Thalomid [prescribing information]. Summit, NJ: Celgene Corporation; 2023. 13. Marqibo [prescribing information]. East Windsor, NJ: Acrotech Biopharma LLC; 2022. 14. Sprycel [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; 2024. 15. Pomalyst [prescribing information]. Summit, NJ: Celgene Corporation; 2021. 16. Doxorubicin hydrochloride [prescribing information]. New York, NY: Pfizer Labs; 2024. 17. Tasigna [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024. 18. Rituxan [prescribing information]. South San Francisco, CA: Genentech, Inc.; 2021. 19. Adcetris [prescribing information]. Bothell, WA: Seagen Inc.; 2025. 20. Ninlaro [prescribing information]. Cambridge, MA: Millennium Pharmaceuticals, Inc.; 2021. 21. Tibsovo [prescribing information]. Boston, MA: Servier Pharmaceuticals LLC; 2023. 22. Kyprolis [prescribing information]. Thousand Oaks, CA: Onyx Pharmaceuticals, Inc.; 2021. 23. Goldman SC, Holcenberg JS, Finkelstein JZ, et al. A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis. Blood. 2001;97:2998-3003. 24. Istodax [prescribing information]. Summit, NJ: Celgene Corporation; 2021. 25. Blincyto [prescribing information]. Thousand Oaks, CA: Amgen Inc.; 2024. 26. Polivy [prescribing information]. South San Francisco, CA: Genentech, Inc.; 2023. 27. Kymriah [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024. 28. 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 24, 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. 29. Wilson FP, Berns JS. Onco-nephrology: tumor lysis syndrome. Clin J Am Soc Nephrol. 2012;7(10):1730-1739. 30. ELITEK [prescribing information]. NJ: Sanofi-Aventis U.S. LLC. 31. Ueng S. Rasburicase (Elitek): a novel agent for tumor lysis syndrome. Proc (Bayl Univ Med Cent). 2005;18(3):275-279. 32. Goldman SC, Holcenberg JS, Finkelstein JZ, et al. A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis. Blood. 2001;97:2998-3003.

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.

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-2020415-v3.0-03/2025