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.

PROPHYLACTIC USE OF ELITEK WAS PROVEN IN A PIVOTAL TRIAL TO PREVENT RISING URIC ACID IN ADULTS1

ELITEK was studied in adult patients at high and intermediate (potential) risk1

9 out of 10

adult patients were at high risk at baseline

82%

of adult patients had normal uric acid levels (≤7.5 mg/dL) at baseline

Adult patients meeting at least 1 of the following criteria were enrolled in the pivotal trial1:

HIGH RISK1-3

Aggressive lymphoma/leukemia (defined by REAL)

  • DLBCL
  • Anaplastic large cell lymphoma
  • Peripheral T-cell lymphomas
  • Burkitt lymphoma
  • Lymphoblastic lymphoma
  • CLL

AML

Elevated plasma uric acid levels (>7.5 mg/dL) at baseline

High-grade MDS with >10% bone marrow blast involvement

CML in blast crisis

INTERMEDIATE (POTENTIAL) RISK1

Aggressive lymphoma/leukemia, not limited to the REAL definition, with LDH ≥2x the upper limit of normal

Any stage III to IV lymphoma or leukemia

Stage I or II disease with bulky lymph node/tumor (>5 cm) involvement

Antihyperuricemic therapy in all 3 arms was initiated prior to anticancer therapy1,4

  • Phase 3: randomized, multicenter, open-label study in adult patients (N=275) with leukemia, lymphoma, and solid tumor malignancies at risk for hyperuricemia and TLS
  • Primary endpoint: response rate defined as the proportion of adult patients with plasmic uric acid levels maintained at ≤7.5 mg/dL between 3 and 7 days after initiation of antihyperuricemic treatment

Adult pivotal trial design1,4

Randomized, multicenter, open-label study comparing ELITEK vs allopurinol (N=275) administered 4 to 24 hours prior to anticancer therapy Randomized, multicenter, open-label study comparing ELITEK vs allopurinol (N=275) administered 4 to 24 hours prior to anticancer therapy

AML=acute myeloid leukemia; CLL=chronic lymphocytic leukemia; CML=chronic myeloid leukemia; DLBCL=diffuse large B-cell lymphoma; MDS=myelodysplastic syndrome; REAL=Revised European American Classification of Lymphoid Neoplasms.

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. Jakić-Razumović J, Aurer I. The World Health Organization classification of lymphomas. Croat Med J. 2002;43(5):527-534.
  3. Nicolaides C, Dimou S, Pavlidis N. Prognostic factors in aggressive non-Hodgkin’s lymphomas. Oncologist. 1998;3(3):189-197.
  4. ELITEK [prescribing information]. Bridgewater, NJ: sanofi-aventis U.S. LLC.

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.