DESCRIPTION
ELITEK (rasburicase) is a recombinant urate-oxidase enzyme produced by a genetically modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus.
Rasburicase is a tetrameric protein with identical subunits of a molecular mass of about 34kDa. The molecular formula of the monomer is C1523H2383N417O462S7. The monomer, made up of a single 301 amino acid polypeptide chain, has no intra- or inter-disulfide bridges and is N-terminal acetylated. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution. ELITEK is supplied in 3-mL colorless, glass vials containing 1.5 mg rasburicase, 10.6 mg mannitol, 15.9 mg L-alanine, and between 12.6 and 14.3 mg of dibasic sodium phosphate.
The diluent solution for reconstitution, supplied in a 2 mL clear, glass ampule, is composed of 1.0 mL sterile Water for Injection, USP, and 1.0 mg Poloxamer 188. The product reconstituted with diluent is a clear, colorless solution.
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