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Drug UPDATES: [Drug information / PDF] PACKAGE INSERT -Dosing: Click (+) next to Dosage and Administration section (drug info link)
Usual Diluents
NS
Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
[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.
Reconstitution Procedure:
Elitek must be reconstituted with the diluent provided in the carton. The diluent from the glass ampule should be filtered to remove potential Glass particle contamination (GPC)
prior to adding to the rasburicase vial for reconstitution. Do not filter the reconstituted product.
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.
Further Dilution and Administration:
Do not administer Elitek as a bolus injection. Administer Elitek as an intravenous infusion only
Inject the calculated dose of reconstituted Elitek solution into an infusion bag containing the appropriate volume of 0.9% sterile sodium chloride, to achieve a final total volume of 50 mL.
Infuse over 30 minutes through a separate line or flush line with at least 15 mL of normal saline prior to and after Elitek infusion.
Do not use filters during infusion of reconstituted Elitek drug product.
Store reconstituted or diluted solution at 2-8°C.
Discard unused product solution 24 hours following reconstitution.
Stability data:
Stability
Refrigerated
Stability
Room Temp.
Reconstituted
Vial/Powder
Notes
24 hours
-
24 hours
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.
Store reconstituted or diluted solution at 2-8°C.
Discard unused product solution 24 hours following reconstitution.
WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS
Hypersensitivity ReactionsElitek® 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)].
HemolysisDo 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)].
MethemoglobinemiaElitek 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 MeasurementsElitek 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
DESCRIPTION
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 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).
CLINICAL PHARMACOLOGY:
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
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
Pregnancy: May cause fetal harm. Use only if the potential benefit to the mother justifies the potential risk to the fetus (8.1).
Nursing Mothers: Discontinue nursing or Elitek taking into account the importance of the drug to the mother (8.3). [Drug information / PDF]
CONTRAINDICATIONS
Contraindications:
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)].
PRECAUTIONS
WARNINGS:
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 package insert - 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 package insert - 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 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
[Drug information / PDF]
DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION: 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.Reconstitution Procedure:
Elitek must be reconstituted with the diluent provided in the carton. The diluent from the glass ampule should be filtered to remove potential Glass particle contamination (GPC)
prior to adding to the rasburicase vial for reconstitution. Do not filter the reconstituted product.
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.
Further Dilution and Administration:
Do not administer Elitek as a bolus injection. Administer Elitek as an intravenous infusion only
Inject the calculated dose of reconstituted Elitek solution into an infusion bag containing the appropriate volume of 0.9% sterile sodium chloride, to achieve a final total volume of 50 mL.
Infuse over 30 minutes through a separate line or flush line with at least 15 mL of normal saline prior to and after Elitek infusion.
Do not use filters during infusion of reconstituted Elitek drug product.
Store reconstituted or diluted solution at 2-8°C.
Discard unused product solution 24 hours following reconstitution.
HOW SUPPLIED
DOSAGE FORMS AND STRENGTHS:
For injection, 1.5 mg, lyophilized powder in single-dose vial
For injection, 7.5 mg lyophilized powder in single-dose vial
Storage and Stability
How Supplied
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.
Manufactured by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
U.S. License No. 1752
