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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There were no patients with documented failure to control uric acid in arms A or B.

Elitek® (rasburicase) IV Infusion | Healthcare Professional Site

Rasburicase is much more expensive than conventional therapy. Cases of anaphylaxis with potential fatal outcome have been reported. Discontinue nursing or Elitek taking into account the importance of the drug to the mother 8. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavu s.

Do not use filters during infusion of reconstituted Elitek drug product. A cross-study comparison revealed that after administration of rasburicase at 0. Hyperuricemia is a component of TLS, and refers to excess uric acid in the blood.

Rasburicase

Rasburicase causes an reaction with an enzyme that turns uric acid into an inactive substance, allantoin, thereby reducing uric acid levels. Elitek is contraindicated in patients with G6PD deficiency because hydrogen peroxide is one of the major by-products of the conversion of uric acid to allantoin. Immediately and permanently discontinue Elitek in patients developing hemolysis.

Interference with uric acid measurements: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Elitek enzymatically degrades uric acid in blood samples left at room temperature.

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The mean terminal half-life was similar between pediatric and adult patients and ranged from Patients rlitek discuss the appropriateness of a particular drug or chemotherapy regimen with their physician. Immediately and permanently discontinue Elitek in patients developing methemoglobinemia [ see Contraindications 4Warnings and Precautions 5.

INDICATIONS AND USAGE

Use only if the potential benefit to the mother justifies the potential risk to the fetus 8. When excess uric acid is present, it is converted to crystals formed of sodium urate.

Among the adult patients in Study 4, hypersensitivity reactions occurred in 4.

The maximum reported overdosage of Elitek is a single dose of 1. Mylan Institutional LLC; 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: The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. 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.

Rasburicase – Wikipedia

Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

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 days of treatment: Clinically relevant Pmediated drug-drug interactions are therefore not anticipated in patients treated with the recommended Elitek dose and dosing schedule.

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Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Archived from the original on When should patients notify their physician? Disclaimer The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. See full prescribing information for complete boxed warning.

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. Study 2 Study 2 was a multi-institutional, single-arm study conducted in 89 pediatric and 18 adult patients with hematologic malignancies.

The mean terminal half-life was similar between pediatric and adult patients and ranged from 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. A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.

Monitor patients who receive an overdose and initiate supportive measures if required. In humans, uric acid is the final step in the catabolic pathway of purines.