Generic Name: oxaliplatin
Dosage Form: Injection

ELOXATIN (oxaliplatin injection) 50mg, 100mg & 200mg Inj Sol for Infusion

WARNING

Eloxatin (oxaliplatin injection) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

Anaphylactic-like reactions to Eloxatin have been reported, and may occur within minutes of Eloxatin administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms

FDA > Eloxatin

Eloxatin® (oxaliplatin injection) is an antineoplastic agent with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1R,2R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)-O,O'] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane(DACH) and with an oxalate ligand as a leaving group.

The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone

Indications and Usage for Eloxatin

Eloxatin, used in combination with infusional 5-FU/LV, is indicated for adjuvant treatment of stage III colon cancer patients who have undergone complete resection of the primary tumor. The indication is based on an improvement in disease-free survival, with no demonstrated benefit in overall survival after a median follow up of 4 years.

Eloxatin, used in combination with infusional 5-FU/LV, is indicated for the treatment of advanced carcinoma of the colon or rectum.

Contraindications

Eloxatin should not be administered to patients with a history of known allergy to Eloxatin or other platinum compounds.

Eloxatin Dosage and Administration

Adjuvant Therapy in Patients with Stage III Colon Cancer

Adjuvant treatment in patients with stage III colon cancer is recommended for a total of 6 months, i.e., 12 cycles, every 2 weeks, according to the dose schedule described below for previously treated patients with advanced colorectal cancer.

Therapy in Previously Untreated and Previously Treated Patients with Advanced Colorectal Cancer

The recommended dose schedule given every two weeks is as follows:

Day 1: Eloxatin 85 mg/m2 IV infusion in 250–500 mL D5W and leucovorin 200 mg/m2 IV infusion in D5W both given over 120 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m2 IV bolus given over 2–4 minutes, followed by 5-FU 600 mg/m2 IV infusion in 500 mL D5W (recommended) as a 22-hour continuous infusion.

Day 2: Leucovorin 200 mg/m2 IV infusion over 120 minutes, followed by 5-FU 400 mg/m2 IV bolus given over 2–4 minutes, followed by 5-FU 600 mg/m2 IV infusion in 500 mL D5W (recommended) as a 22-hour continuous infusion.

Preparation of Infusion Solution

Do not freeze and protect from light the concentrated solution.

A FINAL DILUTION MUST NEVER BE PERFORMED WITH A SODIUM CHLORIDE SOLUTION OR OTHER CHLORIDE-CONTAINING SOLUTIONS.

The solution must be further diluted in an infusion solution of 250–500 mL of 5% Dextrose Injection, USP.

After 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)]. After final dilution, protection from light is not required. 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 is Eloxatin Supplied

Eloxatin is supplied in clear, glass, single-use vials with gray elastomeric stoppers and aluminum flip-off seals containing 50 mg, 100 mg or 200 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/ml. Water for Injection, USP is present as an inactive ingredient.

NDC 0024-0590-10: 50 mg single-use vial with green flip-off seal individually packaged in a carton.

NDC 0024-0591-20: 100 mg single-use vial with dark blue flip-off seal individually packaged in a carton.

NDC 0024-0592-40: 200 mg single-use vial with orange flip-off seal individually packaged in a carton.

Storage

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Do not freeze and protect from light (keep in original outer carton).

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.