"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
ANAPHYLAXIS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS
Elitek® can cause severe hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek in patients who experience a serious hypersensitivity reaction [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].
Do not administer Elitek to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue Elitek 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].
Interference with Uric Acid Measurements
Elitek 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].
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 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)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest pain or tightness, difficult breathing; fainting; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have a serious side effect such as:
- change in your mental state;
- headache, tired feeling, dizziness;
- blue colored lips;
- feeling short of breath;
- feeling like you might pass out;
- fast, slow, or uneven heart rate;
- seizure (convulsions);
- white patches or sores inside your mouth or on your...
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.
Last reviewed on RxList: 6/10/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Elitek Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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