Preparation of Infusion Solution
RECONSTITUTION OR FINAL DILUTION MUST NEVER BE PERFORMED WITH A SODIUM CHLORIDE SOLUTION OR OTHER CHLORIDE-CONTAINING SOLUTIONS.
The lyophilized powder is reconstituted by adding 10 mL (for the 50 mg vial) or 20 mL (for the 100 mg vial) of Water for Injection, USP or 5% Dextrose Injection, USP. Do not administer the reconstituted solution without further dilution. The reconstituted solution must be further diluted in an infusion solution of 250–500 mL of 5% Dextrose Injection, USP.
After reconstitution in the original vial, the solution may be stored up to 24 hours under refrigeration [2–8°C (36–46°F)]. After final dilution with 250–500 mL of 5% Dextrose Injection, USP, the shelf life is 6 hours at room temperature [20–25°C (68–77°F)] or up to 24 hours under refrigeration [2–8°C (36–46°F)].
ELOXATIN is not light sensitive.
ELOXATIN is incompatible in solution with alkaline medications or media (such as basic solutions of 5-FU) and must not be mixed with these or administered simultaneously through the same infusion line. The infusion line should be flushed with D5W prior to administration of any concomitant medication.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and discarded if present.
Needles or intravenous administration sets containing aluminum parts that may come in contact with ELOXATIN should not be used for the preparation or mixing of the drug. Aluminum has been reported to cause degradation of platinum compounds.
HOW SUPPLIED
ELOXATIN is supplied in clear, glass, single-use vials with gray elastomeric stoppers and aluminum flip-off seals containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free lyophilized powder for reconstitution. Lactose monohydrate is also present as an inactive ingredient.
NDC 0024-0596-02: 50 mg single-use vial with green flip-off seal individually packaged in a carton.
NDC 0024-0597-04: 100 mg single-use vial with dark blue flip-off seal individually packaged in a carton.
Storage
Store under normal lighting conditions at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP controlled room temperature].
Handling and Disposal
As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of infusion solutions prepared from ELOXATIN. The use of gloves is recommended. If a solution of ELOXATIN contacts the skin, wash the skin immediately and thoroughly with soap and water. If ELOXATIN contacts the mucous membranes, flush thoroughly with water.
Procedures for the handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published [1–8]. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
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