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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One carton contains 1 single-dose vial containing 7. The incidence of renal dysfunction was similar in the two study arms; one patient in the allopurinol arm developed acute renal failure. In humans, uric acid is the final step eltek the catabolic pathway of purines. Mylan Institutional LLC; Tumor lysis syndrome may occur spontaneously, although the occurrence of this is rare. The diluent from the glass ampule should be filtered to remove potential Glass particle contamination GPC prior to adding to the rasburicase vial for reconstitution.

No adverse events occurred in reported cases of overdosage. The safety and efficacy of Elitek was studied in pediatric patients ranging in age from 1 month to 17 years. Signs and symptoms of these reactions include bronchospasm, chest pain and tightness, dyspnea, hypoxia, hypotension, shock, and urticaria. Hypersensitivity reactions occurred in 4. Rasburicase trade names Elitek in the US and Fasturtec in Europe is a medication that helps to clear precribing acid from the blood.

Because they are reported from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Clinical manifestations of hypersensitivity included arthralgia, injection site irritation, peripheral edema, and rash. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Further studies, including one-active controlled study Study 4 and four supportive studies, have been conducted in adult patients. The pharmacokinetics of rasburicase were evaluated in both pediatric and adult patients with leukemialymphoma or other hematological malignancies. The median uric acid concentration at baseline, at 4 hours following the first dose of Elitek, and the per-patient fall in plasma uric acid concentration from baseline to 4 hours were calculated in those patients with both pre-treatment and 4-hour post-treatment values.

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Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Stability Refrigerated Stability Room Temp.

Elitek rasburicase is supplied in 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1. Immediately and permanently discontinue Elitek in patients developing hemolysis. Additional data were obtained from an expanded access program of patients, for whom data collection was limited to serious adverse reactions.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Methemoglobinemia Elitek can result in methemoglobinemia in some patients.

Study 3 was a multi-institutional, single-arm study conducted in pediatric patients and 1 adult patient with hematologic malignancies.

INDICATIONS AND USAGE

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 prescribinng. Immediately and permanently discontinue Elitek administration in any patient identified as having developed methemoglobinemia.

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. Initiation of dosing prescribig permitted at any time between 4 to 48 hours before the start of anti-tumor therapy and could be continued for 5 to 7 days after initiation of anti-tumor therapy.

Patients were eligible for the study if they were either at high risk or potential risk for TLS.

One carton contains 1 single-dose vial containing 7. Annals of the Rheumatic Diseases.

It is important to use some kind of birth control while undergoing treatment. Detoxifying agents for chemotherapy treatment V03AF. 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.

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Dilution Rasburicase – Elitek® For Injection – GlobalRPH

Disclaimer The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not informatkon substitute for clinical judgment. Assay plasma samples within 4 hours of collection. Hyperuricemia is a component of TLS, and refers to excess uric acid in the blood.

Elitek enzymatically degrades uric acid in blood samples left at room temperature. Patients in Arm B received Elitek from day 1 through day 3 followed by oral allopurinol from day 3 through day 5 overlap on inforkation 3: When should patients notify their physician?

The demographics of the two study arms Elitek vs. Screen patients at higher risk for G6PD deficiency e.

Uric acid is the end product of the digestion of certain proteins and eoitek normally eliminated through the urine. Special sample handling procedure must be followed to avoid ex vivo uric acid orescribing [ see Boxed WarningDrug Interactions 7 ]. Carcinogenicity studies in animals to evaluate tumorigenic potential of rasburicase have not been performed. The incidence of antibody responses detected is highly dependent on the sensitivity and specificity of the assay, which have not been fully evaluated.

Elitek® – Oncology/Hematology of Loudoun and Reston

The pharmacokinetics of rasburicase was evaluated in both pediatric and adult patients with leukemia, lymphoma or other hematological malignancies. What can patients do to help alleviate or prevent discomfort and side effects?

If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.