For U.S. Healthcare Professionals Only

Indication

ELITEK is indicated for the 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. ELITEK is indicated only for a single course of treatment.

For U.S. Healthcare Professionals Only

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Indication

ELITEK is indicated for the 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. ELITEK is indicated only for a single course of treatment.

TLS IS AN ONCOLOGIC EMERGENCY WITH POTENTIALLY DEVASTATING CONSEQUENCES

TLS is caused by 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 chemotherapy or biotherapy1

  • Usually 12 to 72 hours after the start of therapy2

TLS associated with hyperuricemia may lead to serious clinical complications including acute renal failure, cardiac arrhythmias, loss of muscle control, seizures, or death2

Highly effective anticancer therapies can promote rapid cell death leading to TLS3

  • 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
Rapid cell death can cause the release and catabolism of nucleic acids, resulting in the rise of uric acid levels Rapid cell death can cause the release and catabolism of nucleic acids, resulting in the rise of uric acid levels

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

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.3.2019. ©National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed May 15, 2019. 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. https://www.asn-online.org/education/distancelearning/curricula/onco/Chapter4.pdf. Accessed April 15, 2019.

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.

CONTRAINDICATIONS
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 

Please see full Prescribing Information including Boxed WARNING.

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