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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When cancer cells are killed by therapy, they may spill their inner intracellular contents, which accumulate in the body faster than can be eliminated.

Clinically relevant Pmediated drug-drug interactions are therefore not anticipated in patients treated with the recommended Elitek dose and dosing schedule. Discontinue nursing or Elitek taking into account the importance of the drug to the mother 8. The uric acid failure status in those patients is unknown. Blood must be collected into pre-chilled tubes containing heparin anticoagulant. Screen patients at higher risk for G6PD deficiency e. Interference with Uric Acid Measurements Elitek enzymatically degrades uric acid in blood samples left at room temperature.

Tumor lysis syndrome is caused by the sudden, rapid death of cells, particularly cancer cells in patients with leukemia or lymphoma, in response to cancer therapies.

Elitek® (rasburicase) IV Infusion | Healthcare Professional Site

Special sample handling procedure must be followed to avoid ex vivo uric acid degradation [ see Boxed WarningDrug Interactions 7 ]. All but one patient in the Elitek arm had reduction and maintenance of uric acid levels to within or below the normal range during the treatment.

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Dosage The recommended dose of Elitek is 0. Tumor lysis syndrome may occur spontaneously, although the occurrence of this is rare. Control of plasma uric acid in adults at risk for tumor lysis syndrome: Each subunit is made up of a single amino acid polypeptide chain with a molecular mass of about 34 kDa.

The measurement of plasma uric acid was used to evaluate the effectiveness of rasburicase in clinical studies. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Among the adult patients in Study 4, hypersensitivity reactions occurred in 4.

Methemoglobinemia Elitek can result in methemoglobinemia in some patients. May cause fetal harm. Do not use filters during infusion of prdscribing Elitek drug product. Do not administer as an intravenous bolus 2. Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. 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 ].

The mean terminal half-life was similar between informatikn and adult patients and ranged from This is not a complete list of side effects. Discard unused product solution 24 hours following reconstitution.

Discard solution if prescribig matter is visible or product is discolored. There were no patients with documented failure to control uric acid in arms A or B. Some patients may experience other side effects that are not listed here. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. There was no evidence of a dose response effect on uric acid control for prescriblng between 0. Further studies, including one-active controlled study Study 4 and four supportive studies, have been conducted in adult patients.

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In humans, uric acid is the final step in the catabolic pathway of purines. Mix by swirling gently. Patients received Elitek at either a dose of 0. Discontinue nursing or Elitek taking into account the importance of the drug to the mother 8. Screen patients at higher risk for G6PD deficiency e. This drug may cause birth defects. The dose of allopurinol varied according to local institutional practice.

One carton contains 3 single-dose vials each containing 1. Rasburicase is a tetrameric protein with identical subunits. Although the incidence of rash was similar in the two arms, severe rash was reported only in one Elitek-treated patient.

Rasburicase

Elitek is supplied in 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1. International journal of medical sciences. 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. The study population demographics were: Immediately and permanently discontinue Elitek administration in any patient developing clinical evidence of a serious hypersensitivity reaction [ see Boxed WarningContraindications 4Adverse Reactions 6.

Interference with Uric Acid MeasurementsElitek enzymatically degrades uric acid in blood samples left at room temperature.

Dosing beyond 5 days or administration of more than one course is not recommended.

What can patients do to help alleviate or prevent discomfort and side effects? In adults, age, gender, baseline liver enzymes prescibing creatinine clearance did not impact the pharmacokinetics of rasburicase.

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