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 was no evidence of a dose response effect on uric acid control for doses between 0. This can prrescribing at any time during treatment including the first dose. The response rate was higher for arm B compared to arm C; this difference was not statistically significant. The primary study objective was to demonstrate a greater informatiob in uric acid concentration over 96 hours AUC 0—96 hr in the Elitek group as compared to the allopurinol group.
INDICATIONS AND USAGE
Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious. The recommended dose of Elitek is 0.
The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavu s. Rasburicase is approved for use by the U.
Elitek can result in methemoglobinemia in some patients. Uric acid must be analyzed in plasma. 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. 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.
Allopurinol was administered orally at the dose of mg once a day. The primary efficacy objective was determination of the proportion of patients with maintained plasma uric acid concentration at 48 hours as defined for Study 2 above.
Blood must be collected into pre-chilled tubes containing heparin anticoagulant. 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 drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus. The demographics of the two study arms Elitek vs. In humans, uric acid is the final step in the catabolic pathway of purines.
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. Retrieved from ” https: Urate oxidase is known to be present in many mammals but does not naturally occur in humans.
Mylan Institutional LLC; In addition, blood levels of electrolytes and products of digestion or metabolism inforjation be measured frequently, to monitor the extent of TLS.
Interference with Uric Acid Measurements Elitek enzymatically degrades uric acid in blood samples left at room temperature.
Rasburicase exposure, as measured by AUC hr and Cmax, tended to increase with a dose range from 0. There was no evidence of a dose response effect on uric acid control for doses between 0. Study 3 was a multi-institutional, single-arm study conducted in pediatric eelitek and 1 adult patient with hematologic malignancies.
A total of adult patients received at least one dose of study drug.
Elitek® – Oncology/Hematology of Loudoun and Reston
Across the five studies, Elitek was administered at a dose of 0. It is a recombinant version of urate oxidasean enzyme that metabolizes uric acid to allantoin.
Of these patients, adult patients with leukemia, lymphoma, or solid tumor malignancies at risk for hyperuricemia prescribimg tumor lysis syndrome TLS were randomized in an open label trial receiving either Elitek alone, Elitek in combination infformation allopurinol, or allopurinol alone Study 4. Stability Refrigerated Stability Room Temp. Screen patients at higher risk for G6PD infromation e. It is being investigated for treating informaation high blood levels of uric acid from other sources.
Elitek can result in methemoglobinemia in some patients. Elitek enzymatically degrades uric acid in blood samples left at room temperature. Interference with Uric Acid Measurements Elitek enzymatically degrades uric acid in blood samples left at room temperature. Special sample handling procedure must be followed to avoid ex vivo uric acid degradation [ see Boxed WarningDrug Interactions 7 ].
Elitek is supplied in 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1. Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. 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. Discard unused product solution 24 hours following reconstitution.
Patients of African or Mediterranean ancestry may be at higher risk of side effects.
For these reasons, comparison of the incidence of antibodies to Elitek with the incidence of antibodies to other products may be misleading. Immediately and permanently discontinue Elitek in patients developing hemolysis.
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: