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TLS: An Oncologic Emergency with Potentially Devastating Consequences

Tumor lysis syndrome (TLS) is caused by a massive release of intracellular contents into peripheral blood that results in metabolic derangements1

Hyperuricemia

Hyperkalemia

Hyperphosphatemia

Hypocalcemia

TLS is prevalent in hematologic malignancies with1:

  • High proliferative rate
  • Large cellular burden
  • High sensitivity to chemotherapy or cytolytic antibody therapy

TLS occurs spontaneously or in response to anticancer therapy, usually 12 to 72 hours after the start of therapy1,2

TLS associated with hyperuricemia may lead to serious clinical complications2

Are your patients at higher risk for TLS than you think?

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Resource

TLSrisk.com

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Highly effective anticancer therapies can promote rapid cell death leading to TLS1-3

  • Rapid cell death can cause the release and catabolism of nucleic acids, resulting in the rise of uric acid levels
  • Hyperuricemia is one of several metabolic disorders that can lead to TLS, the most common disease-related emergency in hematologic cancers
     
Purple arrow saying occurring spontaneously or post-anticancer therapy, rapid lysis of cancer cells releasees intracellular contents. Title saying metabolic derangements that include hyperkalemia, hyperphosphatemia, hypocalcemia, and hyperuricemia. image with Phosphate increase leads to hyperphosphatemia, phosphate increase also leads to calcium cheltation which also leads to hypocalcemia, Breakdown of DNA leads to release of uric acid ,resulting in elevated uric acid levels which may result in hyperuricemia and potassium increase may lead to hyperkerlamia.

EXPLORE TLS RISK FACTORS

   


Both laboratory and clinical symptoms are key to identifying patients with TLS

Cairo-Bishop classification of TLS4
  

LABORATORY TLS

A patient with 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
CLINICAL TLS

A patient with laboratory TLS and at least 1 of the following:

  • Creatinine ≥1.5x the upper limit of normal (>12 years of age or age adjusted)
  • Cardiac arrhythmia
  • Sudden death
  • Seizure

     

   


TLS is the most common disease-related emergency in hematologic cancers3

Incidence of TLS in patients with hematologic malignancies5
   

Purple circular progress bar surrounding 37% incidence of TLS per year from 2010 to 2014.


In a retrospective analysis, a total of 15,051 cases of TLS were identified among the 40,494 patients with hematologic malignancies during this period

  • This is based on data from the National Inpatient Sample Database, the largest publicly available, all-payer inpatient database5

     

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend that to best manage TLS, anticipate it and initiate treatment prior to anticancer therapy for patients with CLL/SLL, B-cell lymphoma, AML, and ALL2,6-8 

EXPLORE TLS RISK FACTORS

ALL=acute lymphoblastic leukemia; AML= acute myeloid leukemia; CLL=chronic lymphocytic leukemia; NCCN=National Comprehensive Cancer Network; 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. 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. 3. Howard SC, Jones DP, Pui CH. The tumor lysis syndrome. N Engl J Med. 2011;364(19):1844-1854. 4. Edeani A, Shirali A. Chapter 4: Tumor Lysis Syndrome. Onco-Nephrology Curriculum. American Society of Nephrology. 2016. 5. Pathak R, Giri S, Aryal M. Recent trends in the incidence and outcomes of tumor lysis syndrome in hematological malignancies: Data from 2010-2014 National Inpatient Sample. Blood. 2017;130:3390. 6. 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. 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia. V.3.2024. © 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. 8. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia. 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.

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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