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ELITEK (rasburicase) Prescribing Information ELITEK (rasburicase) Medical Information




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 anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ELITEK is indicated for only a single course of treatment.

REFERENCES

  1. Goldman SC, Holcenberg JS, Finklestein JZ, et al. A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis. Blood. 2001; 97:2998-3003.
  2. ELITEK (rasburicase) prescribing information, sanofi-aventis U.S.
  3. Rampello E, Fricia T, Malaguarnera M. The management of tumor lysis syndrome. Nat Clin Pract Oncol. 2006;3:438-447.
  4. Cairo MS, et al. Presented at: 38th Annual Meeting of ASCO; May 18-21, 2002; Orlando, Fla. Abstract 2901.
  5. Bishop MR, Coccia PF. Tumor lysis syndrome. In: Abeloff MD, et al, eds. Clinical Oncology. 2nd ed. New York, NY: Churchill Livingstone; 2000:750-753.
  6. Wetzstein GA. Tumor Lysis Syndrome: A Treatment Guide. New York, NY: McMahon Publishing Group; 2000.
  7. Cairo MS, Bishop M. Tumour lysis syndrome: new therapeutic strategies and classification. Br J Haematol. 2004;127(1):3-11.
  8. Castro MP, VanAuken J, Spencer-Cisek P, Legha S, Sponzo RW. Acute tumor lysis syndrome associated with concurrent biochemotherapy of metastatic melanoma: a case report and review of the literature. Cancer. 1999;85:1055-1059.
  9. Altman A. Acute tumor lysis syndrome. Semin Oncol. 2001;28 (suppl 5):3-8.
  10. Stucky LA. Acute tumor lysis syndrome: assessment and nursing implications. Oncol Nurs Forum. 1993;20:49-59.
  11. Morris JC, Holland JF. Oncologic emergencies. In: Bast RC Jr, Hellman S, Rosenberg SA, eds. Holland-Frei Cancer Medicine. 5th ed. Hamilton, Ontario: B.C. Decker, Inc; 2000:2446-2449.
  12. Jones DP, Mahmoud H, Chesney RW. Tumor lysis syndrome: pathogenesis and management. Pediatric Nephrol. 1995;9:206-212.
  13. Flombaum CD. Metabolic emergencies in the cancer patient. Semin Oncol. 2000;27:322-334.
  14. Coiffier B, Altman A, Ching-Hon P, Younes A, Cario MS. Guidelines for the management of pediatric and adult tumor lysis syndrome: an evidence-based review. J Clin Oncol. 2008;26:2767-2778.
  15. Bessmertny O, Robitaille LM, Cairo MS. Rasburicase: a new approach for preventing and/or treating tumor lysis syndrome: biochemical and clinical relevance of hyperuricemia. Curr Pharmaceut Design. 2005;11:4177-4185.
  16. Stapleton FB, Strother DR, Roy S III, Wyatt RJ, McKay CP, Murphy SB. Acute renal failure at onset of therapy for advanced stage Burkitt lymphoma and B cell acute lymphoblastic lymphoma. Pediatrics. 1988;82:863-869.
  17. Secola R. Tumor lysis syndrome: nursing management and new therapeutic options. Johns Hopkins Adv Stud Nurs. 2006;4(vol 3):43.
  18. Seidemann K, Meyer U, Janson P, et al. Impaired renal function and tumor lysis syndrome in pediatric patients with non-Hodgkin’s lymphoma and B-ALL. Clin Pediatr. 1998;210:279-284.
  19. Lascombes F, Sommelet D, Gebhard F, et al. High efficacy of recombinant urate oxidase in prevention of renal failure related to tumor lysis syndrome (TLS). Blood. 1998;92:237b. Abstract 4019.
  20. Data on file. sanofi-aventis U.S.
  21. Pui C-H, Jeha S, Irwin D, Camitta B. Recombinant urate oxidase (rasburicase) in the prevention and treatment of malignancy-associated hyperuricemia in pediatric and adult patients: results of a compassionate-use trial. Leukemia. 2001;15:1505-1509.
  22. Pui C-H, Mahmoud HH, Wiley JM, et al. Recombinant urate oxidase for the prophylaxis or treatment of hyperuricemia in patients with leukemia or lymphoma. J Clin Oncol. 2001;19:697-704.
  23. Data on file. sanofi-aventis U.S.
  24. Pui C-H. Urate oxidase in the prophylaxis or treatment of hyperuricemia: the United States experience. Semin Hematol. 2001;38(suppl 10):13-22.
  25. Cheson BD, Dutcher, BS. Managing malignancy-associated hyperuricemia with rasburicase. J Support Oncol. 2005;3:117-124.
  26. Aloprim [package insert]. Catalytica Pharmaceuticals, Inc.; 1999.
  27. Zyloprim [package insert]. DSM Pharmaceuticals, Inc.; 2003.

Additional References:

Pui C-H, Relling MV, Lascombes F, et al. Urate oxidase in prevention and treatment of hyperuricemia associated with lymphoid malignancies. Leukemia. 1997;11:1813-1816.

Farber MS. Pharmacoeconomic considerations in the management of acute tumor lysis syndrome. Semin Oncol. 2001;28(2 suppl 5):19-22.

Warrell RP Jr. Metabolic emergencies. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Cancer Principles and Practice of Oncology. 5th ed. Philadelphia, PA: Lippincott-Raven Publishers; 1997;2:2486-2500.

Smalley RV, Guaspari A, Haase-Statz S, Anderson SA, Cederberg D, Hohneker JA. Allopurinol: intravenous use for prevention and treatment of hyperuricemia. J Clin Oncol. 2000;18:1758-1763.

Mahmoud HH, Leverger G, Patte C, Harvey E, Lascombes F. Advances in the management of Malignancyassociated hyperuricaemia. Br J Cancer. 1998;77 (suppl 4):18-20.

Aloprim™ (allopurinol sodium) for Injection Prescribing Information. Greenville, NC: Catalytica Pharmaceuticals Inc.; June 1999.

Zyloprim™ (allopurinol). Prescribing Information. San Diego, CA: Prometheus Laboratories Inc.; 2001.

Wolf G, Hegewisch-Becker S, Hossfeld DK, Stahl RAK. Hyperuricemia and renal insufficiency associated with malignant disease: urate oxidase as an efficient therapy? Am J Kidney Dis. 1999;34:1-6.

Cohen LF, Balow JE, Magrath IT, Poplack DG, Ziegler JL. Acute tumor lysis syndrome: a review of 37 patients with Burkitt’s lymphoma. Am J Med. 1980;68:486-491.

Bowman WP, Shuster JJ, Cook B, et al. Improved survival for children with B-cell acute lymphoblastic leukemia and stage IV small noncleaved-cell lymphoma: a Pediatric Oncology Group study. J Clin Oncol.1996;14:1252-1261.

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IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

Anaphylaxis: ELITEK can cause severe 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.

Important Safety Information

BOXED WARNINGS

Anaphylaxis:
ELITEK can cause severe 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 regardless of severity were assessed in Studies 1, 2 and 3, as well as an uncontrolled safety trial, the most frequently observed adverse reactions (incidence ≥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 the ELITEK alone and 1.1% of patients treated with the ELITEK/oral allopurinol combination. Hypersensitivity reactions included arthralgia, injection site irritation, peripheral edema, and rash. The most common Grade 3 or 4 adverse reactions regardless of relationship to study drug in the 3 arms of Study 4 (ELITEK alone; ELITEK combined with 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 adverse reactions occurred with a difference in incidence of greater than or equal to 2% in patients receiving ELITEK compared to patients receiving oral allopurinol in randomized studies (Study 1 and Study 4): pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections.

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

Please see accompanying full Prescribing Information, including Boxed WARNING.

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US.RAS.09.10.024  Last Update: October 2009