Elitek® (rasburicase) for injection, for intravenous use
|[Prescribed dose ]
[ 0.2 mg/kg ] [50 ml - total volume] [30 minutes]The recommended dose of Elitek is 0.2 mg/kg as a 30 minute intravenous infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than one course is not recommended.
Further Dilution and Administration:
|See warnings and precautions below.
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 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).
|Mechanism of Action:
In humans, uric acid is the final step in the catabolic pathway of purines. Rasburicase catalyzes enzymatic oxidation of poorly soluble uric acid into an inactive and more soluble metabolite (allantoin).
|INDICATIONS AND USAGE:
Elitek® is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.Limitation of use: Elitek is indicated only for a single course of treatment.
USE IN SPECIFIC POPULATIONS
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 WARNING, WARNINGS AND PRECAUTIONS (5)].Elitek is contraindicated in individuals deficient in glucose-6-phosphate dehydrogenase (G6PD) [see BOXED WARNING, WARNINGS AND PRECAUTIONS (5.2)].
WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS
Elitek® can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek in patients who experience a serious hypersensitivity reaction [see package insert - CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.2)].
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 package insert - CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.2)].
Elitek can result in methemoglobinemia in some patients. Immediately and permanently discontinue Elitek in patients developing methemoglobinemia [see package insert - CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.3)].
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
|DOSAGE AND ADMINISTRATION:
The recommended dose of Elitek is 0.2 mg/kg as a 30 minute intravenous infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than one course is not recommended.Reconstitution Procedure:
Further Dilution and Administration:
|DOSAGE FORMS AND STRENGTHS:
For injection, 1.5 mg, lyophilized powder in single-dose vial
NDC 0024-5150-10: One carton contains 3 single-dose vials each containing 1.5 mg of rasburicase and 3 ampules each containing 1 mL diluent.
NDC 0024-5151-75: One carton contains 1 single-dose vial containing 7.5 mg of rasburicase and 1 ampule containing 5 mL diluent.
Storage and Handling
The lyophilized drug product and the diluent for reconstitution should be stored at 2-8°C (36-46°F). Do not freeze. Protect from light.
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