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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Elitek is indicated only for a single course of treatment. Immediately and permanently discontinue Elitek administration in any patient developing hemolysis. Rasburicase trade names Elitek in the US and Fasturtec in Europe is a medication that helps to clear uric acid from the blood. Infuse over 30 minutes through a separate line or flush line with at least 15 mL of normal saline prior to and after Elitek infusion.
Rasburicase exposure, as measured by AUC 0—24 hr and C maxtended to increase with a dose range from 0. Rasburicase is approved for use by the U.
Stability Refrigerated Stability Room Temp. These included cases of serious hypoxemia requiring intervention with medical support measures. Immediately and permanently discontinue Elitek if methemoglobinemia occurs 45. Allopurinol was administered orally at the dose of mg once a day. For example, it has been used for hyperuricemia in gout in other rheumatologic conditions, and in rhabdomyolysis with kidney failure.
Patients in Arm B received Elitek from day 1 through day 3 followed by oral allopurinol from day 3 through day 5 overlap on day 3: Further studies, including one-active controlled study Study 4 and four supportive studies, prescrbiing been conducted in adult patients. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to onformation in the clinical trials of another drug and may not reflect the rates observed in practice.
INDICATIONS AND USAGE
See full prescribing information for complete precsribing warning. What is a package insert? Assay plasma samples within 4 hours of collection 5. Rasburicase catalyzes enzymatic oxidation of poorly soluble uric acid into an inactive and more soluble metabolite allantoin with carbon dioxide and hydrogen peroxide as byproducts in the chemical reaction. Elitek rasburicase prsscribing supplied in 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.
Discard unused product solution 24 hours following reconstitution. It is not known whether rasburicase is excreted in human milk. Screen patients at higher risk for G6PD deficiency e.
Additional data were obtained from an expanded access program of patients, for whom data collection was limited to serious adverse reactions. When should presxribing notify their physician?
Rasburicase administration can cause anaphylaxis incidence unknown ; methemoglobinemia may occur in susceptible individuals such as those with G6PDH deficiency due to the production of hydrogen peroxide in the urate oxidase reaction.
Elitek is supplied in 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of infromation. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Hypersensitivity reactions occurred in 4.
Rasburicase – Wikipedia
Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Blood must be collected into pre-chilled tubes containing heparin anticoagulant. Do not use filters during infusion of reconstituted Elitek infromation product. It is unknown whether rasburicase can cross the placental barrier in humans and result in fetal harm.
It is not known whether patients with deficiency of cytochrome b 5 reductase formerly known as methemoglobin reductase or of other enzymes with antioxidant activity are at increased risk for methemoglobinemia or hemolytic anemia. This drug may cause birth defects. Weight-based Dosing Provides Reliability and Control In pivotal trial of ELITEK in adults, cytoreductive therapy was initiated between 4 and 24 hours after the first dose of antihyperuricemic treatment.
This is not a complete list of side effects. Rasburicase is a tetrameric protein with identical subunits. One carton contains 3 single-dose vials each containing 1. Of these patients, adult patients with leukemia, lymphoma, or solid tumor malignancies at risk for hyperuricemia and tumor lysis syndrome TLS were randomized in an open label trial receiving either Elitek alone, Elitek in combination with allopurinol, or allopurinol alone Study 4.
Dilution Rasburicase – Elitek® For Injection – GlobalRPH
May eitek fetal harm. Study 2 was a multi-institutional, single-arm study conducted in 89 pediatric and 18 adult patients with hematologic malignancies. Immediately and permanently discontinue Elitek if hemolysis occurs.
By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug.