Rasburicase(Fasturtec)
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ELITEK® (rasburicase) is a recombinant urate oxidase enzyme specifically designed for the management of tumor lysis syndrome (TLS) in patients with malignancies like leukemia, lymphoma, and solid tumors. It helps lower elevated plasma uric acid levels by enzymatically converting uric acid into a more soluble substance, allantoin, thus preventing complications associated with hyperuricemia. Typically administered as an intravenous infusion, ELITEK® is given daily for a short duration, generally up to five days.
As a targeted therapy for elevated uric acid levels caused by rapid tumor breakdown during cancer treatment, ELITEK® is a vital tool in managing the metabolic complications of tumor lysis syndrome. Careful patient screening for conditions such as G6PD deficiency and close monitoring of treatment are essential for safety.
Generic name
Rasburicase(Fasturtec)
Alternative Names
Fasturtec
Indications
Elitek® is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, or solid tumor malignancies receiving anticancer therapy expected to cause tumor lysis syndrome (TLS) and subsequent hyperuricemia.
Therapeutic Target
Catalyzes enzymatic oxidation of uric acid into allantoin, a soluble metabolite, preventing urate nephropathy, acute kidney injury, and TLS complications.
Active Ingredients
Rasburicase (recombinant urate-oxidase).
specifications
NDC 0024-5150-10: 3 vials (1.5 mg each) + 3 ampules (1 mL diluent).
Description
Structure: Tetrameric protein (301 amino acids per subunit; molecular mass ~34 kDa).
Source: Produced by genetically modified Saccharomyces cerevisiae using cDNA from Aspergillus flavus.
Appearance: Sterile, white to off-white lyophilized powder.
Dosage and Administration
Dose: 0.2 mg/kg/day as a 30-minute IV infusion for ≤5 days.
Reconstitution:
1.5 mg vial: 1 mL diluent.
7.5 mg vial: 5 mL diluent.
Do not shake; swirl gently.
Administration:
Dilute in 0.9% NaCl to total 50 mL.
Infuse via separate line; flush with 15 mL saline pre/post-infusion.
Storage: Reconstituted/diluted solutions stored at 2°C–8°C; discard after 24 hours.
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