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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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. Other side effects do not require medical attention prezcribing may go away during treatment. For example, it has been used for hyperuricemia in gout[6] in other rheumatologic conditions, and in rhabdomyolysis with kidney failure.

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

This drug may cause birth defects. Tumor Lysis Syndrome 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: Screen patients at higher risk for G6PD deficiency e.

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

Important Limitations of Use 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.

Mix by swirling gently. Elitek is indicated only for a single course of treatment. These prescribint cases of serious hypoxemia requiring intervention with medical support measures.

Rasburicase – Wikipedia

Special sample handling procedure must be followed to avoid ex vivo uric acid degradation [ see Boxed WarningDrug Interactions 7 ]. From Wikipedia, the free encyclopedia. Glucosephosphate dehydrogenase G6PD deficiency 4.

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The mean terminal half-life was similar between pediatric and adult patients and ranged from Do not shake or vortex. This page was last edited on 19 Julyat In pivotal trial of ELITEK in adults, cytoreductive therapy was initiated between 4 and 24 hours after the first dose of antihyperuricemic treatment.

What can patients do to help alleviate or prevent discomfort and side effects? Following administration of either 0. A total of adult patients received at least one dose of study drug. The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Supportive care Generic Name: Rasburicase causes an reaction with an enzyme that turns uric acid into an inactive substance, allantoin, thereby reducing uric acid levels. The Cochrane Database of Systematic Reviews.

INDICATIONS AND USAGE

There are no studies of rasburicase in pregnant women. 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 presccribing doctor. Pregnant rabbits dosed daily with 10 to times the human prescrkbing 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.

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. Patients were eligible for the study if they were either at high risk or potential risk for TLS. It is unknown whether rasburicase can cross the placental barrier in humans and result in fetal harm.

The study population demographics were: In humans, uric acid is the final step in the catabolic pathway of purines. The measurement of plasma uric acid was prescrlbing to evaluate the effectiveness of rasburicase in clinical studies. infofmation

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Some side effects may require medical attention. Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. Across the five studies, Elitek was administered at a dose of 0. Carcinogenicity studies in animals to evaluate tumorigenic potential of rasburicase have not been performed.

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Rasburicase

This is not a complete list of side effects. Use only if the potential benefit to the mother justifies the potential risk to the fetus 8. What is a package insert? A total of adults with either leukemia, lymphoma, or other hematologic malignancy received Elitek in five studies one randomized study, Study 4, and inormation uncontrolled studies.

Immediately and permanently discontinue Elitek in patients who experience a serious hypersensitivity reaction [ see Contraindications 4Warnings and Precautions 5. Elitek must be reconstituted with the diluent provided in the carton. A cross-study comparison revealed that after administration of rasburicase at prescribig. Immediately and permanently discontinue Elitek administration in any patient identified as having developed methemoglobinemia.

In humans, uric acid is the final step in the catabolic pathway of purines. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath.

Interference with Uric Acid Measurements Elitek enzymatically degrades uric acid in blood samples left at room temperature. No adverse events occurred in reported cases of overdosage. No overall differences in pharmacokinetics, safety, and effectiveness were observed between the elderly elitekk younger patients.

The following serious adverse reactions are discussed in greater detail in other sections of the prescribing prescrlbing.