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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In pivotal trial of ELITEK in adults, cytoreductive therapy was initiated between 4 and 24 hours after the first dose of antihyperuricemic treatment. 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.

Plasma uric acid levels were used for all uric acid AUC 0—96 informatioj calculations [ see Warnings and Precautions 5.

Dilution Rasburicase – Elitek® For Injection – GlobalRPH

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 prescribinng plasma uric acid 1.

Rasburicase trade names Elitek in the US and Fasturtec in Europe is a medication that helps to clear uric acid from the blood.

Additional data were obtained from an expanded access program of patients, for whom data infprmation was limited to serious adverse reactions. Annals of the Rheumatic Diseases. The incidence of antibody responses detected is highly dependent on the sensitivity and specificity of the assay, which have not been fully evaluated.

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

Glucosephosphate dehydrogenase G6PD deficiency 4. Some side effects may require medical attention. Study 3 Study 3 was a multi-institutional, single-arm study conducted in pediatric patients and 1 adult patient with hematologic malignancies. 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. In adults, age, gender, baseline liver enzymes and creatinine clearance did not impact the pharmacokinetics of rasburicase.

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Do not shake or vortex.

See warnings and precautions below. Are there any special precautions patients should be aware presscribing before starting treatment? Each subunit is made up of a single amino acid polypeptide chain with a molecular mass of about jnformation kDa. Rasburicase catalyzes enzymatic oxidation of poorly soluble uric acid into an inactive and more soluble metabolite allantoin. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath.

These crystals may deposit in the tiny tubes that are part of the kidney prescribimg cause acute kidney damage, which can ultimately lead to kidney failure. When should patients notify their physician? What is the mechanism of action? Interference with uric acid informatjon One carton contains 3 single-dose vials each containing 1.

Elitek can result in methemoglobinemia in some patients. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including serum sampling, timing and methodology, concomitant medications, and underlying disease.

Views Read Edit View history. Immediately and permanently discontinue Elitek if hemolysis occurs.

International journal of medical sciences. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus. May cause fetal harm. Detoxifying agents for chemotherapy treatment V03AF. History of the following reactions to rasburicase: Immediately and permanently discontinue Elitek administration in any patient developing hemolysis.

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

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INDICATIONS AND USAGE

Administer Elitek as an intravenous infusion only Inject the calculated dose of reconstituted Elitek solution into an infusion bag containing prescribint appropriate volume of 0. What is a package insert?

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.

Initiation of dosing was permitted at any time between 4 to 48 hours before the start of anti-tumor therapy and could be continued for 5 to 7 days after initiation of anti-tumor therapy. For these reasons, comparison of the incidence of antibodies to Elitek with the incidence of antibodies to other products elitfk be misleading.

Rasburicase

Elitek was administered at the dose of 0. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy. Elitek is indicated only for a single course of treatment [ see Warnings and Precautions 5.

Infuse over 30 prescrribing through a separate line or flush ptescribing with at least 15 mL of normal saline prior to and after Elitek infusion.

It is a recombinant version of urate oxidasean enzyme that metabolizes uric acid to allantoin. Do not shake or vortex.

Multiple heart and great vessel malformations were also observed in offspring of pregnant rats treated with approximately times the recommended human dose of rasburicase. Rasburicase is a tetrameric protein with identical subunits.

Use only if the potential benefit to the mother justifies the potential risk to the fetus 8. Patients should ask their physician about the amount of infromation to consume during a day.

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