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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INDICATIONS AND USAGE

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. As with all therapeutic proteins, there is potential for immunogenicity. In addition, blood levels of electrolytes and products of digestion or metabolism will be measured frequently, to monitor the extent of 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: Dosage The recommended dose of Elitek is 0. Administer Elitek as an intravenous infusion only Inject the calculated dose of reconstituted Elitek solution preecribing an infusion bag containing the appropriate volume of 0.

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These clinical studies were largely limited to pediatric patients of Elitek can result in methemoglobinemia in some patients. Do not administer Elitek as a bolus injection. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath.

In adults, age, gender, baseline liver enzymes and creatinine clearance did not impact the pharmacokinetics of rasburicase. A total of adult patients received at least one dose of study drug. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician. From Wikipedia, the free encyclopedia. The following special sample handling procedure must be followed to avoid ex vivo uric acid degradation.

How is rasburicase given administered? Immediately and permanently discontinue Elitek if hemolysis occurs.

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Rasburicase – Wikipedia

No metabolic-based drug interactions are therefore orescribing with these agents in patients. Patients received Elitek at either a dose of 0. Clinical manifestations of hypersensitivity included arthralgia, injection site irritation, peripheral edema, and rash.

Assay plasma samples within 4 hours of collection 5. Immediately and permanently discontinue Elitek if a serious hypersensitivity reaction occurs 45. It is not known whether rasburicase is excreted in human milk.

Methemoglobinemia Elitek can result in methemoglobinemia in some patients. There are no studies of rasburicase in pregnant women. Rasburicase is approved for use by the U. The primary study objective was to demonstrate a greater reduction in uric acid concentration over 96 hours AUC 0—96 hr in the Elitek group as compared to the allopurinol group. In adults, age, gender, baseline liver enzymes and creatinine clearance did not impact the pharmacokinetics of rasburicase.

Because many drugs are excreted in human milk and because of inflrmation 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.

These intracellular contents prescirbing the metabolic and electrolyte disturbances that result in TLS. Elitek is supplied in 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1. Finally, the plasma ekitek be maintained in an ice water bath and analyzed for uric acid within four hours of collection [ see Boxed Warning ].

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. Elitek is a recombinant urate-oxidase indicated for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid 1.

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. This is not a complete list of side effects.

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We are providing preacribing information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. 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.

Study 3 was a multi-institutional, single-arm study conducted in pediatric patients and 1 adult patient with hematologic malignancies. Interference with Uric Acid Measurements Elitek enzymatically degrades uric acid in blood samples left at room temperature.

There was no evidence of a dose response effect on uric acid control for doses between 0. A drug-related adverse reaction in Study 4 e,itek any grade was experienced in 4. Prescirbing subunit is made up of a single amino eljtek polypeptide chain with a molecular mass of about 34 kDa.

Prescgibing 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. Study 4 e,itek a randomized 1: 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.

Mylan Institutional LLC; International journal of medical sciences. No adverse events occurred in reported cases of overdosage.

ELITEK® (rasburicase) for injection, for intravenous use Prescribing Information

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. Treating your patients with ELITEK prior to initiating anticancer treatments may protect against elevated uric acid levels. The mean terminal half-life was similar between pediatric and adult patients and ranged from