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 pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection.
  • Among the 347 (265 pediatric; 82 adult) patients for whom all adverse reactions (ARs) regardless of severity were assessed in Studies 1, 2 and 3, as well as an uncontrolled safety trial, the most common ARs (≥10%) were vomiting (50%), fever (46%), nausea (27%), headache (26%), abdominal pain (20%), constipation (20%), diarrhea (20%), mucositis (15%), and rash (13%).
  • Among the 275 adult patients in Study 4, hypersensitivity reactions occurred in 4.3% of patients treated with ELITEK alone and 1.1% of patients treated with the ELITEK plus oral allopurinol. Hypersensitivity reactions included arthralgia, injection site irritation, peripheral edema, and rash. The most common Grade 3‐4 ARs regardless of relationship to study drug in Study 4 (ELITEK alone; ELITEK plus oral allopurinol; oral allopurinol alone) were sepsis (5.4%; 6.5%; 4.4%), hypophosphatemia (4.3%; 6.5%; 6.6%), anxiety (3.3%; 0%; 0%), abdominal pain (3.3%; 4.3%; 2.2%), hyperbilirubinemia (3.3%; 2.2%; 4.4%), and increased alanine aminotransferase (3.3%; 4.3%; 2.2%), respectively.
  • The following serious ARs occurred with a difference in incidence of ≥2% in patients receiving ELITEK vs. oral allopurinol in Study 1 and Study 4: pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections.

Please see full Prescribing Information including Boxed WARNING.

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