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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Dosing beyond 5 days or administration of more than one course is not recommended. Study 3 was a multi-institutional, single-arm study conducted in pediatric patients and 1 adult patient with hematologic malignancies.

Dilution Rasburicase – Elitek® For Injection – GlobalRPH

The pharmacokinetics of rasburicase was evaluated in both pediatric and adult patients with leukemia, lymphoma or other hematological malignancies. 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: Allopurinol was administered orally at the dose of mg once a day.

Some patients may experience other side effects that are not listed here.

A drug-related adverse reaction in Study 4 of any grade was experienced in 4. In Study 1, an active control study, the following adverse reactions occurred more frequently in Elitek-treated subjects than allopurinol-treated subjects: Rasburicase is a tetrameric protein with identical subunits.

Elitek is contraindicated in individuals eljtek in glucosephosphate dehydrogenase G6PD [ see Boxed WarningWarnings and Precautions 5. The measurement of plasma uric acid was used to evaluate the effectiveness of rasburicase in clinical studies. All but one patient in the Elitek informationn had reduction and maintenance of uric acid levels to within or below the normal range during the treatment.

Interference with Uric Acid MeasurementsElitek enzymatically degrades uric acid eitek blood samples left at room temperature. It is unknown whether rasburicase can cross the placental barrier in humans and result in fetal harm.

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Rasburicase

Rasburicase catalyzes enzymatic oxidation of poorly soluble uric acid into an inactive and more soluble metabolite allantoin. Interference with Uric Acid Measurements Elitek enzymatically degrades uric acid in blood samples left at room temperature.

It is innformation investigated for treating severely high blood levels of uric acid from other sources. The following special sample handling procedure must be followed to avoid ex vivo uric acid degradation.

Signs and symptoms of these reactions include bronchospasm, chest pain and tightness, dyspnea, hypoxia, hypotension, shock, and urticaria.

Immediately and permanently discontinue Elitek if methemoglobinemia occurs 45. By using this site, you agree to the Terms of Use and Privacy Policy. Dosing beyond 5 days or administration of more than one course is not recommended. How is this drug used? Further Dilution and Administration: Immediately and permanently discontinue Elitek administration in any patient identified as having developed methemoglobinemia.

Treating your patients with ELITEK prior to initiating anticancer treatments may protect against elevated uric acid levels.

This page was last edited on 19 Julyat In humans, uric acid is the final step in the catabolic pathway of purines. Figure 1 is a box and whisker plot of plasma uric acid levels inclusive of of the Elitek treated patients from Studies 1, 2, and 3.

There was no evidence of a dose response effect on uric acid control for doses between 0.

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

When cancer cells are killed by therapy, they may spill their inner intracellular contents, informagion accumulate in the body faster than can be eliminated. Study 3 Study 3 was a multi-institutional, single-arm study conducted in pediatric patients and 1 adult patient with hematologic malignancies. Hypersensitivity reactions included arthralgia, injection site irritation, peripheral edema, and rash.

Carcinogenicity presdribing in animals to evaluate tumorigenic potential of rasburicase have not been performed. Assay plasma samples within 4 hours of collection.

INDICATIONS AND USAGE

Elitek is contraindicated in patients with a history of anaphylaxis or severe hypersensitivity to rasburicase or in patients with development of hemolytic reactions or methemoglobinemia with rasburicase [ see Boxed WarningWarnings and Precautions 5 ]. Informafion cause fetal harm. Hemolysis Do not administer Elitek to patients with glucosephosphate dehydrogenase G6PD deficiency.

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Across the five studies, Elitek was administered at a dose prescribung 0. See warnings and precautions below. Additional data were obtained from an expanded access program of patients, for whom data collection was limited to serious adverse reactions. Each subunit is made up of a single amino acid polypeptide chain with a molecular mass of about 34 kDa. Study 2 was a multi-institutional, single-arm study infor,ation in 89 pediatric and 18 adult patients with hematologic malignancies.

Prescribign sample handling procedure must be followed to avoid ex vivo uric acid degradation [ see Boxed WarningDrug Interactions 7 ]. 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. Archived from the original on Do not shake or vortex.

Urate oxidase is known to be present in many mammals but does not naturally occur in humans. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems. Plasma uric acid levels were used informatiom all uric acid AUC 0—96 hr calculations [ see Warnings and Precautions 5. The study population demographics were: Rasburicase is FDA approved for the management of uric acid levels in pediatric patients onformation leukemia, lymphoma and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome and subsequent elevation of uric acid in the blood.