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)
Elitek (Rasburicase) Immuno-Monitoring Study [Recruiting]
To determine the incidence, titer and type of anti-rasburicase antibodies in the context of
hypersensitivity reaction(s) or the loss of uricolytic activity occurring in patients with
relapsed leukemia/lymphoma who have been re-treated with rasburicase and have experienced a
hypersensitivity reaction or loss of uricolytic activity.
Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma [Completed]
The primary objectives of the study are to evaluate the safety and the efficacy in patients
with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days
in two dosage groups.
Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to
assess anti-SR29142 antibody production in patients with malignant lymphoma and acute
leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the
results of efficacy and safety evaluations.
Rasburicase for Hyperuricemia [Completed]
Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed
hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma
uric acid concentration.
Secondary: To investigate the safety in this population and anti-SR29142 antibodies, anti-SCP
antibodies, and pharmacokinetic parameters.
Rasburicase (Fasturtec) Registration Trial [Recruiting]
To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related
hyperuricemia in Chinese patients with leukemia or lymphoma.
To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients
stratified according to disease (leukemia or lymphoma ).
Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma [Terminated]
The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and
treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult
patients, previously treated or not with urate oxidase, with relapsing aggressive
non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky
disease at diagnostic of relapse.
The secondary objectives were to :
- evaluate the efficacy of rasburicase in terms of renal protection,
- evaluate the safety of rasburicase in the two cohorts of patients,
- correlate efficacy and safety results with antibodies generation/level.
Page last updated: 2013-02-10