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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A total of adults with either leukemia, lymphoma, or other hematologic malignancy received Elitek in five studies one randomized study, Informatiin 4, and four uncontrolled studies.

Control of plasma uric acid in adults at risk for tumor lysis syndrome: It is not known whether rasburicase is excreted in human milk.

A cross-study comparison revealed that after administration of rasburicase at 0. Hyperuricemia is a component of TLS, and refers to excess uric acid in the blood.

A package insert is required by the FDA presccribing contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. Trial Design Efficacy Safety Dosing. Interference with uric acid measurements: Screen patients at higher risk for G6PD deficiency e. This can occur at any time during treatment including the first dose. Immediately immerse plasma samples for uric acid measurement in an ice water bath.

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Rasburicase exposure, as measured by AUC hr and Cmax, tended to increase informatioh a dose range from 0.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, prescribiing, and any supportive care.

The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information:. Prescribint of anaphylaxis with potential fatal outcome have pgescribing reported. Study 3 was a multi-institutional, single-arm study conducted in pediatric patients and 1 adult patient with hematologic malignancies.

Patients should ask their physician about the amount of liquid to consume during a day. For these reasons, comparison of the incidence of antibodies to Elitek with the incidence of antibodies to other products may be misleading. Teratogenic effects included multiple heart and great vessel malformations at all dose levels. Weight-based Dosing Provides Reliability and Control In pivotal trial of ELITEK in adults, cytoreductive therapy was initiated between 4 and 24 hours after the first dose of antihyperuricemic treatment.

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

The dose of allopurinol varied according to local institutional practice. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ presxribing, such as the kidneys or liver.

Patients may wish to discuss with their physician the other less common side effects of this drug, elitei of which may be serious. Interference with Uric Acid MeasurementsElitek enzymatically degrades uric acid in blood samples left at room temperature.

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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.

Allergic reactions may be severe, including shock. Retrieved from ” https: Each subunit is made up of a single amino unformation polypeptide chain with a molecular mass of about 34 kDa. Some patients may experience other side prescribong that are not listed here. 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.

Rasburicase

This drug may cause birth defects. Dosing beyond 5 days or administration of more than one course is not recommended. Patients received Elitek at a dose of 0.

HemolysisDo not administer Elitek to patients with glucosephosphate dehydrogenase G6PD deficiency. Monitor patients who receive an overdose and initiate indormation measures if required. Study 2 was a multi-institutional, single-arm study conducted in 89 pediatric and 18 adult patients with hematologic malignancies.

Among the adult patients in Study 4, hypersensitivity reactions occurred in 4. Tumor lysis syndrome may eliteek spontaneously, although the occurrence of this is rare. Rasburicase is much more expensive than conventional therapy.