ELOXATIN

Eloxatin Generic Name & Formulations

Legal Class

General Description

Oxaliplatin 5mg/mL; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Alkylating agent (organoplatinum complex).

How Supplied

Single-use vials (50mg, 100mg)—1

Manufacturer

Sanofi U.S.

Generic Availability

YES

Mechanism of Action

In in vitro and in vivo studies, oxaliplatin exhibits antiproliferative activity in several tumor models [HT29(colon), GR (mammary), and L1210 (leukemia)] in combination with 5-FU.

Eloxatin Indications

Indications

Adjuvant treatment for Stage III colon cancer in patients who have undergone complete resection of the primary tumor (in combination with infusional 5-FU/LV). Treatment of advanced colorectal cancer (in combination with infusional 5-FU/LV).

Eloxatin Dosage and Administration

Adult

See full labeling. Give by IV infusion every two weeks for a total of 6 months (12 cycles) for adjuvant use or until disease progression or unacceptable toxicity for advanced disease. Day 1: 85mg/m² + leucovorin, followed by 5-FU. Day 2: Leucovorin followed by 5-FU. Severe renal impairment: initially 65mg/m². Dose modifications: see full labeling.

Children

Not established.

Administration

Does not require prehydration. 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; flush infusion line with 5% dextrose inj prior to administration of any concomitant medication. Needles or IV administration sets containing aluminum parts should not be used; may degrade platinum compounds.

Eloxatin Contraindications

Contraindications

Known allergy to other platinum-based drugs.

Eloxatin Boxed Warnings

Boxed Warning

Hypersensitivity reactions, including anaphylaxis.

Eloxatin Warnings/Precautions

Warnings/Precautions

Monitor for hypersensitivity reactions; permanently discontinue if occurs. Monitor for neuropathy; reduce dose or discontinue if needed. Severe neutropenia: delay therapy until neutrophils ≥1.5×10⁹/L; withhold for sepsis or septic shock; reduce dose after recovery. Monitor WBCs with differential, hemogloblin, platelets, blood chemistries (including ALT, AST, bilirubin, creatinine) before each cycle. Discontinue if interstitial lung disease or pulmonary fibrosis is suspected. Patients with CHF, bradyarrhythmias, electrolyte abnormalities: monitor ECG. Correct hypokalemia or hypomagnesemia prior to initiation; monitor periodically during therapy. Congenital long QT syndrome; avoid. Renal impairment. Avoid extravasation. Embryo-fetal toxicity. Advise to use effective contraception during and for ≥9 months (females of reproductive potential) or 6 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after the last dose).

Eloxatin Pharmacokinetics

Distribution

Volume of distribution: 440 L.

Plasma protein bound: >90%.

Metabolism

Nonenzymatic biotransformation.

Elimination

Renal (54%), fecal (2%).

Half-life: 391 hours.

Eloxatin Interactions

Interactions

Avoid concomitant drugs known to prolong the QT interval (including Class Ia and III antiarrhythmics). Avoid concomitant drugs known to cause nephrotoxicity. Monitor oral anticoagulants.

Eloxatin Adverse Reactions

Adverse Reactions

Peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, GI upset, increased liver enzymes, fatigue, stomatitis; allergic reactions, pulmonary fibrosis (may be fatal), hepatotoxicity, QT prolongation, ventricular arrhythmias, rhabdomyolysis (may be fatal; discontinue if occurs), hemorrhage.

Eloxatin Clinical Trials

See Literature

Eloxatin Note

Notes

Testing considerations: ERCC1 overexpression

Eloxatin Patient Counseling