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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Monitor patients who receive an overdose and initiate supportive measures if required. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent.

Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician. Mix by swirling gently. Hemolysis Do not administer Predcribing to patients with glucosephosphate dehydrogenase G6PD deficiency.

Rasburicase – Wikipedia

Some patients may experience other side effects that are not listed here. Immediately and permanently discontinue Elitek if hemolysis occurs.

Patients will also be monitored for allergic-type reactions that may occur with treatment with rasburicase, including difficulty breathing, chest pain, prescribibg, hives, low blood pressure, closing of the throat and lightheadedness. There were no patients with documented failure to control uric acid in arms A or B.

Elitek rasburicase is supplied in 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1. 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 exposure, as measured by AUC 0—24 hr and C maxtended to increase with ekitek dose range from 0.

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INDICATIONS AND USAGE

Do not shake or vortex. Control of plasma uric acid in adults at risk for tumor lysis syndrome: This can occur at any time during presceibing including the first dose. Carcinogenicity studies in animals to evaluate tumorigenic potential of rasburicase have not been performed.

Do not filter the reconstituted product.

Rasburicase

Following administration of either 0. Elitke trade names Elitek in the US and Fasturtec in Europe is a medication that helps to clear uric acid from the blood. Methemoglobinemia Elitek can result in methemoglobinemia in some patients. Patients will usually have scheduled meetings with their healthcare provider while they presctibing being treated with rasburicase. Study 2 was a multi-institutional, single-arm study conducted in 89 pediatric and 18 adult patients with hematologic malignancies.

Do not administer Elitek to patients with glucosephosphate dehydrogenase G6PD deficiency. Please see package insert for additional information and possible updates to ensure safe and effective use of this medication.

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

Views Read Edit View history. Rasburicase catalyzes enzymatic oxidation of poorly soluble uric acid into an inactive and more soluble metabolite allantoin. From Wikipedia, the free encyclopedia. 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. Figure 1 is a box and whisker plot of plasma prescribinf acid levels inclusive of of the Elitek treated patients from Studies 1, 2, and 3.

Do not shake or vortex. Dosing beyond 5 days or administration of more than one course is not recommended. Use only if the potential benefit to the mother justifies the potential risk to the fetus 8. Patients received Elitek at either a dose of 0. Do not administer as an intravenous bolus 2. Elitek can cause serious and informatioh hypersensitivity reactions including anaphylaxis. Assay plasma samples within 4 hours of collection.

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Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Elitek enzymatically degrades uric acid in blood samples left at room temperature. Across the five studies, Elitek was administered at a dose informmation 0. May cause fetal harm. Table 2 presents the response rates in the three treatment arms.

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

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. The primary study objective was to demonstrate a greater reduction in uric acid concentration over 96 hours AUC 0—96 hr in the Elitek group as compared to the allopurinol group.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Are there any special precautions patients should be aware of before starting treatment? Rasburicase is much more expensive than conventional therapy.

This page was last edited on 19 Julyat What can patients do to help alleviate or prevent discomfort and side effects? The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent.