Colorectal and other GI cancers:

Indications for ELOXATIN:

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).

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.

Contraindications:

Known allergy to other platinum-based drugs.

Boxed Warning:

Hypersensitivity reactions, including anaphylaxis.

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 x 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).

Pharmacologic Class:

Alkylating agent (organoplatinum complex).

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.

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.

Note:

Testing considerations: ERCC1 overexpression

Generic Availability:

YES

How Supplied:

Single-use vials (50mg, 100mg)—1

Pricing for ELOXATIN

20ml of 100mg/20ml vial (Qty: 1)
Appx. price $41
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