Elitek (Rasburicase) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 16, 2012

Elitek

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Leukemia facts

Leukemia is a cancer of the blood cells.
While the exact cause(s) of leukemia is not known, risk factors have been identified.
Leukemias are grouped by how quickly the disease develops (acute or chronic) as well as by the type of blood cell that is affected (lymphocytes or myelocytes). The four main types of leukemia include acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), acute myelocytic leukemia (AML), and chronic myelocytic leukemia (CML).
People with leukemia are at significantly increased risk for developing infections, anemia, and bleeding. Other symptoms and signs include easy bruising, weight loss, night sweats, and unexplained fevers.
The diagnosis of leukemia is supported by findings of the medical history and examination, and examining blood and bone marrow samples under a microscope.
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Elitek

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ELITEK
(rasburicase) Powder for Solution, for Intravenous Infusion

WARNING: ANAPHYLAXIS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS Anaphylaxis

Elitek (rasburicase) ® can cause severe hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek (rasburicase) in patients who experience a serious hypersensitivity reaction [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].

Hemolysis

Do not administer Elitek (rasburicase) to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue Elitek (rasburicase) in patients developing hemolysis. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].

Methemoglobinemia

Elitek (rasburicase) can result in methemoglobinemia in some patients. Immediately and permanently discontinue Elitek (rasburicase) in patients developing methemoglobinemia [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].

Interference with Uric Acid Measurements

Elitek (rasburicase) enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

Elitek (rasburicase) is a recombinant urate-oxidase produced by a genetically modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus.

Rasburicase is a tetrameric protein with identical subunits. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kDa. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Elitek (rasburicase) is supplied in 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.5 mg/mL after reconstitution.

Elitek 1.5 mg presentation contains 1.5 mg rasburicase, 10.6 mg mannitol, 15.9 mg L-alanine, between 12.6 and 14.3 mg of dibasic sodium phosphate (lyophilized powder), and a diluent (1 mL Water for Injection, USP, and 1 mg Poloxamer 188).

Elitek 7.5 mg presentation contains 7.5 mg of rasburicase, 53 mg mannitol, 79.5 mg L-alanine, and between 63 and 71.5 mg dibasic sodium phosphate (lyophilized powder) and a diluent (5 mL Water for Injection, USP, and 5 mg Poloxamer 188).

What are the possible side effects of rasburicase (Elitek)?

In rare cases, the use of rasburicase has been associated with blood problems (methemoglobinemia, hemolytic reactions) and serious allergic reactions. Contact your doctor immediately if you develop swelling of the lips, tongue, or face; chest pain; shortness of breath; dizziness; hives; or bluish skin or lips. These may be symptoms of a serious reaction.

Other, less serious side effects may be more likely to occur. Continue to take rasburicase and talk to your doctor if you experience:

diarrhea;
abdominal...

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What are the precautions when taking rasburicase (Elitek)?

Also see the Warnings section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult the doctor or pharmacist if you have: previous severe allergic reaction to this medication, certain metabolic conditions (e.g., G6PD deficiency), previous red blood cell damage (e.g., hemolysis, methemoglobinemia) with this medication.

Before using this medication, tell the doctor the medical history, especially of: kidney disease, dehydration.

Caution is...

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Last reviewed on RxList: 11/2/2009
This monograph has been modified to include the generic and brand name in many instances.