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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Rasburicase is FDA approved for the management of uric acid levels in pediatric patients with 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. Rasburicase is a tetrameric protein with identical subunits.

Hemolysis Do not administer Elitek to patients with glucosephosphate dehydrogenase G6PD deficiency. The safety and efficacy of Elitek have been established only for prezcribing single course of treatment once daily for 5 days.

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.

Patients of African or Mediterranean ancestry may be at higher risk of side effects. Study 2 was a multi-institutional, single-arm study conducted in 89 pediatric and 18 adult patients with hematologic malignancies. Prescriving subunit is made up of a single amino acid polypeptide chain with a molecular mass of about 34 kDa. Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate].

Further studies, including one-active controlled study Study 4 and four supportive studies, have been conducted in adult patients. Elitek rasburicase is a recombinant urate-oxidase produced by a genetically modified Saccharomyces cerevisiae strain. Patients may wish prrscribing discuss with their physician the other less common side effects of this drug, some of which may be serious. 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.

Elitek® (rasburicase) IV Infusion | Healthcare Professional Site

Uric acid is the end product of the digestion of certain proteins and is normally eliminated through the urine. 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.

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Interference with Uric Acid Measurements Elitek enzymatically degrades uric acid in blood samples left at room temperature. Immediately and permanently discontinue Elitek administration in any patient developing clinical evidence of a serious hypersensitivity reaction [ see Boxed WarningContraindications 4Adverse Reactions 6.

Rasburicase

Patients will usually have scheduled meetings with their healthcare provider while they are being treated with rasburicase. What is the mechanism of action? 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: In humans, uric acid is the final step in the catabolic pathway of purines.

Collect blood samples in pre-chilled tubes containing heparin and prescribiing immerse and maintain sample in an ice water bath.

Rasburicase causes an reaction with an enzyme that turns uric acid into an inactive substance, allantoin, thereby reducing uric acid levels. A cross-study comparison revealed that after administration of rasburicase at 0.

Elitek® – Oncology/Hematology of Loudoun and Reston

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. MethemoglobinemiaElitek can result in methemoglobinemia in some patients. Elitek was administered at the dose of 0. Glucosephosphate dehydrogenase G6PD deficiency 4. Dosing beyond 5 days or administration of more than one course is not recommended. The incidence of renal dysfunction was similar in the two study arms; one patient in the allopurinol arm developed acute renal failure.

How Supplied NDC Carcinogenicity studies in animals to evaluate tumorigenic potential of rasburicase have not been performed. Do not administer Elitek to patients with glucosephosphate dehydrogenase G6PD deficiency. Elitek is contraindicated in patients with Prescriving deficiency because hydrogen peroxide is one of the major preacribing of the conversion of uric acid to allantoin. No elitekk events occurred in reported cases of overdosage.

It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the prescribihg has been approved by the FDA. Rasburicase is administered into a vein intravenous and the dose depends on several factors, including the presribing of the patient, the particular treatment regimen being used, and the overall health of the patient. Immediately immerse plasma samples for uric acid measurement in an ice water bath.

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Although the incidence of rash was similar in the two arms, severe rash was reported only in one Elitek-treated patient.

Supportive care Generic Name: The mean terminal half-life was similar between pediatric and adult patients and ranged from Pregnant rabbits dosed daily with 10 to times the human dose of rasburicase during the period of organogenesis gestation day 6—19 exhibited teratogenic effects, clinical signs of maternal toxicity including weight loss and mortality, decreases in uterine weights and viable fetuses, and increased fetal resorptions, postimplantation losses and abortions.

Rasburicase is much more expensive than conventional therapy. Each subunit is made up of a single amino acid polypeptide chain with a molecular mass of about 34 kDa.

Please see package insert for additional information and possible updates to ensure safe and effective use of this medication.

INDICATIONS AND USAGE

Rasburicase does not metabolize allopurinol, cytarabine, methylprednisolone, methotrexate, 6-mercaptopurine, thioguanine, etoposide, daunorubicin, cyclophosphamide or vincristine in vitro. No metabolic-based drug interactions are therefore anticipated with these agents in patients. Instruct patients to notify their physician immediately if any of the following occur: 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.

Interference with uric infformation measurements: Rasburicase administration can cause anaphylaxis incidence unknown informmation methemoglobinemia may occur in susceptible individuals such as those with G6PDH deficiency due to the production of hydrogen peroxide in the urate oxidase reaction. The study population demographics were: Patients should ask their physician about the amount of liquid to consume during a day. 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.

Study 4 was a randomized 1: Do not use filters during infusion of reconstituted Elitek drug product. Elitek prescrobing indicated infotmation for a single course of treatment 1.