NEWS HIGHLIGHTSMedia Articles Related to Elitek (Rasburicase)
ASN: Hyperuricemia Treatment May Save Infants' Kidneys (CME/CE)
Source: MedPage Today Nephrology [2009.11.04]
SAN DIEGO (MedPage Today) -- Hyperuricemia occurring in infants with acute kidney injury was effectively treated with a single dose of the recombinant urate oxidase (rasburicase) according to findings reported here.
Published Studies Related to Elitek (Rasburicase)
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 study of rasburicase for the management of hyperuricemia in pediatric patients with newly diagnosed hematologic malignancies at high risk for tumor lysis syndrome. [2009.08.22]
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.
Single-dose rasburicase for tumour lysis syndrome in adults: weight-based approach. [2009.04]
CONCLUSION: Rasburicase is an effective treatment for patients with hyperuricaemia and may aid in the prevention of hyperuricaemia-associated nephrotoxicity. From our experience, a single dose of 0.15 mg/kg (IBW or aBW) of rasburicase appears to effectively decrease and maintain urate levels within normal limits for 48 h.
Efficacy of rasburicase in hyperuricemia secondary to Lesch-Nyhan syndrome. [2009.04]
We report on a 16-day-old male with metabolic acidosis, hyperuricemia, hyperuricosuria, and nephrocalcinosis caused by Lesch-Nyhan syndrome. Activity of the hypoxanthine-guanine phosphoribosyl transferase (HPRT) enzyme in lysed erythrocytes was undetectable, and molecular DNA analysis confirmed the presence of a 4-base pair deletion at the 5' end of intervening sequence 8 in the HPRT1 gene, a change that affects a 5' splice site consensus sequence.
Clinical Trials Related to Elitek (Rasburicase)
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 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.
Fasturtec TLS Treatment / Prophylysis [Completed]
Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS [Completed]
Primary
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)
Secondary
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.
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