ELITEK PRESCRIBING INFORMATION PDF

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 for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. Elitek can elicit anti-product antibodies that bind to rasburicase and in some instances inhibit the activity of rasburicase in vitro [ see Boxed WarningWarnings and Precautions 5.

Patients of Infkrmation or Mediterranean ancestry may be at higher risk of side effects. Institute appropriate patient monitoring and support measures e. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavu s. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug.

There was no evidence of a dose response effect on uric acid control for doses between 0. Clinically relevant Pmediated drug-drug interactions are therefore not anticipated in patients treated with the recommended Elitek dose and dosing schedule.

It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA.

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Mylan Institutional LLC; A cross-study comparison revealed that ekitek administration of rasburicase at 0. Among the adult patients in Study 4, hypersensitivity reactions occurred in 4. There were no patients with documented failure to control uric acid in arms A or B.

The primary efficacy objective was determination of the proportion of patients with maintained plasma uric acid concentration at 48 hours where maintenance of uric acid concentration was defined as: It is being investigated for treating severely high blood levels of uric acid from other sources.

Elitek is indicated only for a single course elutek treatment [ see Warnings and Precautions 5. Assay plasma samples within 4 hours of collection [ see Warnings and Precautions 5.

Dilution Rasburicase – Elitek® For Injection – GlobalRPH

These intracellular contents cause the metabolic and electrolyte disturbances that result in TLS. It is not known whether rasburicase is excreted in human milk. Assay plasma samples within 4 hours of collection.

Pregnant rabbits dosed daily with 10 to times the human dose of rasburicase during the period of organogenesis gestation day 6—19 exhibited teratogenic effects, clinical signs of rpescribing toxicity including weight loss and mortality, decreases in uterine weights and viable fetuses, and increased fetal resorptions, postimplantation losses and abortions.

Tumor prescribinng syndrome may occur spontaneously, although the occurrence of this is rare.

Table 2 presents the response rates in the three treatment arms. Teratogenic effects included multiple heart and great vessel malformations at all dose levels. Institute appropriate monitoring and support measures e. Because of the observed teratogenic effects of rasburicase in animal reproductive studies, use rasburicase during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Patients should check with their physician about any side effects that continue or are bothersome.

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INDICATIONS AND USAGE

What can patients do to help alleviate or prevent discomfort and side effects? Interference with Uric Acid Measurements Elitek enzymatically degrades uric acid in blood samples left at room temperature.

Interference with uric acid measurements: The median uric acid concentration at baseline, at 4 hours following the first dose of Elitek, and the per-patient fall in plasma uric acid concentration from baseline to 4 hours were calculated in those patients with both pre-treatment and 4-hour post-treatment values.

Carcinogenicity studies in animals to evaluate tumorigenic potential of rasburicase have not been performed. One carton contains 1 single-dose vial containing 7.

Tumor Lysis Syndrome TLS Clinical TLS was defined by changes in at least two or more laboratory parameters for hyperuricemia, hyperkalemia, hyperphosphatemia and hypocalcemia and at least one of the following events occurring within 7 prescriblng of treatment: From Wikipedia, the free encyclopedia. The maximum reported overdosage of Elitek is a single dose of 1.

Control of plasma uric acid in adults at risk for tumor lysis syndrome: The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus.

Hemolysis Do not administer Elitek to patients with glucosephosphate dehydrogenase G6PD deficiency. 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.

The measurement of plasma uric acid was used to evaluate the effectiveness of rasburicase in clinical studies. In pivotal trial of ELITEK in adults, cytoreductive therapy was initiated between 4 and 24 hours after the first dose of antihyperuricemic treatment.