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Label 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. FDA label
Also known as rasburicase (SR29142), urate oxidase
rasburicase · 3 trials · 6 indications
Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 \<7.5 mg/dl.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Rasburicase alone given as a single agent for 5 days |
| Arm B | EXPERIMENTAL | Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap) |
| Arm C | ACTIVE_COMPARATOR | Oral allopurinol alone given as a single agent for 5 days |
| Name | Type | Description |
|---|---|---|
| Rasburicase (SR29142) | DRUG | 30-min IV infusion |
| Allopurinol | DRUG | Oral administration |
Inclusion Criteria: 1. Meets high risk or at potential risk for tumor lysis syndrome (TLS): A patient is at high risk for TLS if he/she presents with: * Hyperuricemia of malignancy (plasma uric acid \> 7.5 mg/dL); * A diagnosis of very aggressive lymphoma/leukemia based on the Revised Eur...
Rasburicase is used to treat hyperuricemia in patients with leukemia, lymphoma, or other cancers who are at risk for tumor lysis syndrome. It is also studied in nutritional and metabolic diseases. The drug is given to lower uric acid levels that can rise rapidly when cancer cells break down during treatment.
Rasburicase is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the company responsible for the clinical development and regulatory submissions for rasburicase.
Rasburicase has been studied in Phase 2 and Phase 3 clinical trials. The Phase 3 trial, NCT00230178, compared rasburicase with allopurinol in tumor patients at risk for hyperuricemia and tumor lysis syndrome. All listed trials are completed, and no active trials are currently recruiting.
Rasburicase has been evaluated in three completed trials: NCT00631579, a Phase 2 study of rasburicase as uricolytic therapy in leukemia or lymphoma patients with hyperuricemia; NCT00290992, a Phase 2 study in nutritional and metabolic diseases; and NCT00230178, a Phase 3 comparison with allopurinol in tumor patients at risk for tumor lysis syndrome.
Yes, rasburicase is also known by the code name SR29142. Rasburicase (SR29142) refers to the same drug candidate developed by Sanofi. The alternative name may appear in scientific literature or regulatory documents.