Elitek
ELITEK
rasburicase
Anaphylaxis
ELITEK may cause severe hypersensitivity reactions including anaphylaxis. ELITEK should be immediately and permanently discontinued in any patient developing clinical evidence of a serious hypersensitivity reaction (see WARNINGS, Anaphylaxis and ADVERSE REACTIONS, Immunogenicity).
Hemolysis
ELITEK administered to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency can cause severe hemolysis. ELITEK administration should be immediately and permanently discontinued in any patient developing hemolysis. It is recommended that patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) be screened prior to starting ELITEK therapy (see CONTRAINDICATIONS and WARNINGS, Hemolysis).
Methemoglobinemia
ELITEK use has been associated with methemoglobinemia. ELITEK administration should be immediately and permanently discontinued in any patient identified as having developed methemoglobinemia (see WARNINGS, Methemoglobinemia).
Interference with Uric Acid Measurements
ELITEK will cause enzymatic degradation of the uric acid within blood samples left at room temperature, resulting in spuriously low uric acid levels. To ensure accurate measurements, blood must be collected into pre-chilled tubes containing heparin anticoagulant and immediately immersed and maintained in an ice water bath; plasma samples must be assayed within 4 hours of sample collection (see PRECAUTIONS, Laboratory Test Interactions).
DRUG 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 34 kDa. 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.
Generic Name: Rasburicase
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