Rx Item-Elitek rasburicase INTRAVEN VIAL 1.5Mg Vial 3 By Aventis Pharm Refrig

ELITEK- rasburicase
sanofi-aventis U.S. LLC

WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS

Hypersensitivity Reactions

Elitek� can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek in patients who experience a serious hypersensitivity reaction [see Contraindications (4), Warnings and Precautions (5.1), Adverse Reactions (6.2)].



Hemolysis

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 (4), Warnings and Precautions (5.2)].

Methemoglobinemia

Elitek can result in methemoglobinemia in some patients. Immediately and permanently discontinue Elitek in patients developing methemoglobinemia [see 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 [see Warnings and Precautions (5.4) ].

1 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 [see Warnings and Precautions (5.1)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosage
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.

2.2 Reconstitution Procedure
Elitek must be reconstituted with the diluent provided in the carton.
Reconstitute the 1.5 mg vial of Elitek with 1 mL of diluent. Reconstitute the 7.5 mg vial of Elitek with 5 mL of diluent. Mix by swirling gently. Do not shake or vortex.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard solution if particulate matter is visible or product is discolored.

RX ITEM-Elitek 1.5Mg Vial 3 By Aventis P
NDC 00024-5150-10 UPC/GTIN No.3-00245-15010-3 Mfg.Part No.515010

Elitek 1.5Mg Vial 3 By Aventis Pharm Ref
BRAND: ELITEK NDC: 00024-5150-10,24515010 UPC: 3-00245-15010-3,300245150103 Aventis Pharmaceuticals

RASBURICASE INTRAVEN VIAL
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