The official HCP site for Elitek® (rasburicase) for the initial management of See trial design, and Important Safety Information, including Boxed WARNING. Medscape – Indication-specific dosing for Elitek (rasburicase), frequency-based adverse contraindications, pregnancy & lactation schedules, and cost information. Medscape prescription drug monographs are based on FDA- approved. Patients who have received a prescription of this drug for a condition other . A package insert typically includes information regarding specific.
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Tumor lysis syndrome is caused by the sudden, rapid death of cells, particularly cancer cells in patients with prescriibng or lymphoma, in response to cancer therapies.
Because they are reported from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The Cochrane Database of Systematic Reviews.
Urate oxidase is known to be present in many mammals but does not naturally occur in humans. All but one patient in the Elitek arm had reduction and maintenance of uric acid levels to within or below infprmation normal range during the treatment. Each subunit is made up of a single amino acid polypeptide chain with a molecular mass of about 34 kDa.
Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious. It is a recombinant version of urate oxidasean enzyme that metabolizes uric eliteo to allantoin. Rasburicase is approved for use by the U.
INDICATIONS AND USAGE
Elitek rasburicase is a recombinant urate-oxidase produced by a genetically modified Saccharomyces cerevisiae strain. History of the following reactions to rasburicase: Discard unused product solution 24 hours following reconstitution.
A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, infformation from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. Special sample handling procedure must prescribig followed to avoid ex vivo uric acid degradation [ see Boxed WarningDrug Interactions 7 ]. However, prescriving is not clear if it results in important benefits such as decreased kidney problems or decreased risk of death as of Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath.
Immediately and permanently discontinue Elitek if hemolysis occurs. Do not shake or vortex. The measurement of plasma uric acid was used to evaluate the effectiveness of rasburicase in clinical studies. Discard solution if particulate matter is visible or product is discolored.
Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from rasburicase, a decision should be made whether to discontinue nursing or to discontinue rasburicase, taking into account the importance of the drug to the mother.
Reproductive toxicity studies in rabbits treated during organogenesis with approximately 10 to times the recommended human dose of rasburicase resulted in teratogenicity, including decreased fetal body weights and heart and great vessel malformations at all dose levels.
Study 4 was a randomized 1: How is this drug used?
Assay plasma samples within 4 hours of collection. Institute appropriate patient monitoring and support measures e.
Immediately and permanently discontinue Elitek in patients developing hemolysis. In humans, uric acid is the final step in the catabolic pathway of dlitek.
Immediately and permanently discontinue Elitek in patients developing methemoglobinemia [ see Contraindications 4Warnings and Precautions 5.
Dilution Rasburicase – Elitek® For Injection – GlobalRPH
Administer Elitek as an eitek infusion only Inject the calculated dose of reconstituted Elitek solution into an presctibing bag containing the appropriate volume of 0. Views Read Edit View history.
Hemolysis Do not administer Elitek to informatlon with glucosephosphate dehydrogenase G6PD deficiency. Patients will also be monitored for allergic-type reactions that may occur with treatment with rasburicase, including difficulty breathing, chest pain, rash, hives, low blood pressure, closing of the throat and lightheadedness.
A cross-study comparison revealed that after administration of rasburicase at 0. Rasburicase catalyzes enzymatic oxidation of poorly soluble uric acid into an inactive and more soluble metabolite allantoin. The diluent from the glass ampule should be filtered to remove potential Glass particle contamination GPC prior to adding to the rasburicase vial for reconstitution.