WARNING: ANAPHYLAXIS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS
Elitek® can cause severe hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek in patients who experience a serious hypersensitivity reaction [see Contraindications (4), Warnings and Precautions, Adverse Reactions
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 [see Contraindications (4), Warnings and Precautions
Elitek can result in methemoglobinemia in some patients. Immediately and permanently discontinue Elitek in patients developing methemoglobinemia [see Contraindications (4), Warnings and Precautions
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 [see Warnings and Precautions
Elitek (rasburicase) is a recombinant urate-oxidase produced by a genetically modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavu s.
Rasburicase is a tetrameric protein with identical subunits. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kDa. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Elitek is supplied in 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.5 mg/mL after reconstitution.
Elitek 1.5 mg presentation contains 1.5 mg rasburicase, 10.6 mg mannitol, 15.9 mg L-alanine, between 12.6 and 14.3 mg of dibasic sodium phosphate (lyophilized powder), and a diluent (1 mL Water for Injection, USP, and 1 mg Poloxamer 188).
Elitek 7.5 mg presentation contains 7.5 mg of rasburicase, 53 mg mannitol, 79.5 mg L-alanine, and between 63 and 71.5 mg dibasic sodium phosphate (lyophilized powder) and a diluent (5 mL Water for Injection, USP, and 5 mg Poloxamer 188).
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.
Limitation of use: Elitek is indicated only for a single course of treatment [see Warnings and Precautions].
Published Studies Related to Elitek (Rasburicase)
[Rasburicase versus allopurinol in the treatment of hyperuricaemia in tumour lysis syndrome] [2010.02]
INTRODUCTION: Hyperuricaemia accompanying tumour lysis syndrome (TLS) is a serious complication in neoplasias with rapid proliferation and cellular destruction. The aim of the study was to evaluate the effects of rasburicase versus allopurinol on plasma uric acid, creatinine and phosphorus levels in paediatric patients with TLS... CONCLUSION: This study demonstrated that there is more rapid control and lower plasma uric acid levels in patients at high risk for tumour lysis syndrome who received rasburicase compared to allopurinol, as well as lower levels of creatinine and a lower percentage of haemodialysis.
A study of rasburicase for the management of hyperuricemia in pediatric patients with newly diagnosed hematologic malignancies at high risk for tumor lysis syndrome. [2009.11]
Tumor lysis syndrome (TLS), including hyperuricemia, is a frequent serious complication in patients with hematologic malignancies. This study in Japanese patients evaluated the efficacy, safety, and pharmacokinetic profile of rasburicase in pediatric patients with hematologic malignancies... Rasburicase is effective and well tolerated for the management of hyperuricemia in Japanese pediatric patients at high risk of developing TLS.
A single dose of rasburicase in elderly patients with hyperuricaemia reduces serum uric acid levels and improves renal function. [2009.04]
AIM: Given the relevance of hyperuricaemia in the development of several diseases, we evaluated rasburicase, generally used in tumor lysis syndrome for uric acid treatment. Our purpose was to evaluate the reduction of serum uric acid and the improvement in renal function... CONCLUSION: In hyperuricaemic elderly patients, a single dose of rasburicase is very effective in lowering serum uric acid levels. Moreover, in patients treated with rasburicase we noted an improvement of renal function. We conclude that rasburicase is an alternative resource for treating those patients who are allopurinol intolerant, have renal dysfunction or have multiple polypharmacy problems in which drug-drug interaction may be of concern.
A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis. [2001.05.15]
Standard therapy in the United States for malignancy-associated hyperuricemia consists of hydration, alkalinization, and allopurinol... For pediatric patients with advanced stage lymphoma or high tumor burden leukemia, rasburicase is a safe and effective alternative to allopurinol during initial chemotherapy.
A randomized trial of a single-dose rasburicase versus five-daily doses in
patients at risk for tumor lysis syndrome. 
the optimal duration of therapy is unknown in adults... CONCLUSIONS: Rasburicase is highly effective for prevention and management of
Clinical Trials Related to Elitek (Rasburicase)
Rasburicase in Patients at Risk for Tumor Lysis Syndrome [Completed]
To determine the efficacy of rasburicase administered as a single dose followed by as needed
dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm)
in the treatment of patients at high risk or potential risk for tumor lysis syndrome.
1. To evaluate the plasma uric acid area under the curve (AUC) from baseline through 7
2. To evaluate the incidence of renal insufficiency and electrolyte abnormalities.
3. To determine the safety and immunogenicity of rasburicase.
4. To evaluate the cost-effectiveness of the experimental treatment (investigational arm).
Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS [Completed]
1. To determine the pharmacokinetic (PK) parameters of rasburicase in adult patients with
leukemia and/or lymphoma at high risk or potential risk of tumor lysis syndrome (TLS)
1. To evaluate plasma uric acid AUC from baseline (within 4 hours prior to first
rasburicase treatment) through 48 hours after the last per-protocol planned
administration of rasburicase treatment;
2. To evaluate the safety of rasburicase in adult patients with leukemia and/or lymphoma.
3. To evaluate incidence, duration, and type of immune responses (IgG, IgE, and
neutralizing antibody) to rasburicase.
Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies [Terminated]
This randomized phase II trial studies how well giving rasburicase together with allopurinol
works in treating patients with hematologic malignancies. Rasburicase may reduce the level
of uric acid in the blood. Allopurinol may stop the growth of cancer cells by blocking some
of the enzymes needed for cell growth. It is not yet known which dose of rasburicase is more
effective in treating hematologic malignancies when given together with or without
Rasburicase in Patients at High Risk for Tumor Lysis Syndrome (TLS) During Cycle-2 [Recruiting]
The goal of this clinical research study is to learn if using Elitek (rasburicase) for 2
cycles can help to control or prevent TLS better than 1 cycle of rasburicase and 1 cycle of
allopurinol. The safety of this treatment will also be studied.
Fasturtec TLS Treatment / Prophylysis [Completed]
Page last updated: 2013-02-10