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Various Factors Increase the Risk of Developing TLS1-3

There are a wide range of patient and tumor-specific factors that can increase the risk of tumor lysis syndrome (TLS) and hyperuricemia in your patients1-3

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High tumor burden

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Elevated uric acid
levels at baseline

Icon: Cluster of overlapping cells in a purple circle.

Bulky disease

Icon: Dotted diagonal arrow pointing upward in a purple circle.

Elevated WBC count

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Lymph node
involvement

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Bone marrow
involvement

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Renal disease or renal
involvement by tumor

This is not a comprehensive list of all potential risk factors.

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Patients with high uric acid levels (>8.0 mg/dL) are at high risk for developing TLS4

Relationship between uric acid level and development of TLS in patients with hematologic malignancies4*

    

Table showing Uric Acid levels with Percentage of Risk from High (>8.0mg/dL) dark grey line of 85.7%, Medium (4.0-8.0 mg/dL) lighter grey line of 23.4% with P<0.001 for High vs Medium and Low (<4.0 mg/dL) light grey bar 4.23% with P<0.001 for Medium vs low.

*Results from a retrospective analysis conducted to determine the relationship between uric acid levels and TLS in 1198 patients with a hematologic malignancy who were admitted for inpatient chemotherapy.

   
 

Preventing a rise in uric acid is essential for protecting patients against TLS associated with hyperuricemia

     
 

Certain anticancer agents have been associated with elevated uric acid or TLS6-28
  

Agents treating hematologic malignancies associated with risk of increasing uric acid or TLS6-28†


   

Venetoclax

Bendamustine HCl‡§

Vincristine sulfate§

Nilotinib

Ivosidenib

Blinatumomab

Ibrutinib

Imatinib mesylate

Dasatinib

Rituximab§

Carfilzomib

Polatuzumab vedotin-piiq

Axicabtagene ciloleucel

Obinutuzumab

Pomalidomide

Brentuximab vedotin

Bortezomib

Tisagenlecleucel

Lenalidomide

Thalidomide

Doxorubicin HCl§

Ixazomib

Romidepsin


    

†This is not a comprehensive list of agents.
‡There is an increased risk of severe skin toxicity when bendamustine HCl is used concomitantly with allopurinol.
§Components of the R-CHOP regimen. R=rituximab, C=cyclophosphamide, H=doxorubicin hydrochloride (hydroxydaunomycin), O=vincristine sulfate (Oncovin®), P=prednisone.


    

Venetoclax therapy and TLS

The National Comprehensive Cancer Network (NCCN®) has specifically developed a set of supportive care recommendations for TLS in patients with CLL or SLL who have been prescribed venetoclax therapy1

  • Venetoclax can cause a rapid reduction of the tumor, thus increasing risk for TLS6
  • In patients with CLL who followed the current (5 week) dose ramp-up and the TLS prophylaxis and monitoring measures, the rate of TLS was 2% in the venetoclax CLL monotherapy studies. With a 2 to 3 week dose ramp-up and higher starting dose in patients with CLL/SLL, the TLS rate was 13% and included deaths and renal failure6
  • The risk of TLS is a continuum based on multiple factors, including tumor burden and comorbidities. Patients should be assessed for risk and should receive appropriate prophylaxis for TLS, including hydration and antihyperuricemics. Monitor blood chemistries and manage abnormalities promptly. Interrupt dosing if needed. Employ more intensive measures (intravenous hydration, frequent monitoring, hospitalization) as overall risk increases6
  • Please refer to venetoclax package insert for additional management considerations

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend TLS prophylaxis and monitoring based on tumor burden in patients with CLL/SLL receiving venetoclax1:

  • Management of patients with CrCl <80 mL/min and medium tumor burden (any lymph node 5 cm to <10 cm or ALC ≥25 x 109/L) as high risk for TLS
  • Consider rasburicase for patients with both high tumor burden and elevated baseline uric acid‖

‖In patients receiving venetoclax therapy, high tumor burden is defined as any lymph node ≥10 cm or ALC ≥25 x109/L and any lymph node ≥5 cm.


     

Certain malignancies are associated with increased risk for TLS

Patients with (but not limited to) these hematologic malignancies may be at risk for TLS2:

  • Acute Iymphoblastic leukemia (ALL)
  • Acute myeloid leukemia (AML)
  • Chronic myeloid leukemia (CML)
  • Burkitt lymphoma (BL)
  • Diffuse large B-cell lymphoma (DLBCL)
  • Multiple myeloma (MM)
  • Chronic lymphocytic leukemia (CLL)


     

EXPLORE ELITEK STUDY DESIGN

ALC=absolute lymphocyte count; CLL=chronic lymphocytic leukemia; CrCl=creatinine clearance; SLL=small lymphocytic lymphoma; WBC=white blood cell.

References: 1. 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.  2. Wilson FP, Berns JS. Onco-nephrology: tumor lysis syndrome. Clin J Am Soc Nephrol. 2012;7(10):1730-1739. 3. 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 their content, use or application and disclaims any responsibility for their application or use in any way. 4. Cairo MS. Prevention and treatment of hyperuricemia in hematological malignancies. Clin Lymphoma. 2002;3(S1):S26-S31. 5. Edeani A, Shirali A. Chapter 4: Tumor Lysis Syndrome. Onco-Nephrology Curriculum. American Society of Nephrology. 2016. 6. Venclexta [prescribing information]. North Chicago, IL: AbbVie Inc; July 2024. 7. Imbruvica [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; May 2024. 8. Yescarta [prescribing information]. Santa Monica, CA: Kite Pharma, Inc; 2024. 9. Revlimid [prescribing information]. Princeton, NJ: Bristol-Myers Squibb; March 2023. 10. Bendeka [prescribing information]. Parsippany, NJ: Teva Pharmaceuticals; 2021. 11. Gleevec [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; August 2022. 12. Gazyva [prescribing information]. South San Francisco, CA: Genentech, Inc.; July 2022. 13. Thalomid [prescribing information]. Princeton, NJ: Bristol-Myers Squibb; March 2023. 14. Marqibo [prescribing information]. East Windsor, NJ: Acrotech Biopharma LLC; March 2022. 15. Sprycel [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; July 2024. 16. Pomalyst [prescribing information]. Princeton, NJ: Bristol-Myers Squibb; March 2023. 17. Doxorubicin hydrochloride [prescribing information]. New York, NY: Pfizer Labs; 2013. 18. Tasigna [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; February 2024. 19. Rituxan [prescribing information]. South San Francisco, CA: Genentech, Inc; December 2021. 20. Adcetris [prescribing information]. Bothell, WA: Seagen, Inc.; June 2023. 21. Ninlaro [prescribing information]. Lexington, MA: Takeda Pharmaceuticals, Inc.; July 2024. 22. Tibsovo [prescribing information]. Boston, MA: Servier Pharmaceuticals LLC; 2023. 23. Kyprolis [prescribing information]. Thousand Oaks, CA: Onyx Pharmaceuticals, Inc.; June 2022. 24. Velcade [prescribing information]. Lexington, MA: Takeda Pharmaceuticals America, Inc.; November 2021. 25. Istodax [prescribing information]. Princeton, NJ: Bristol-Myers Squibb; July 2021. 26. Blincyto [prescribing information]. Thousand Oaks, CA: Amgen Inc.; 2024. 27. Polivy [prescribing information]. South San Francisco, CA: Genentech, Inc.; 2023. 28. Kymriah [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024.

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-2020410-v4.0-03/2025

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