Drug Information

Questions and Answers about Eloxatin (oxaliplatin for injection)

Eloxatin is a platinum-based anticancer drug. It is the platinum that destroys the cancer cells. The active ingredient in Eloxatin is oxaliplatin.

Eloxatin is given in combination with 5-fluorouracil plus leucovorin (5FU/LV) to treat advanced cancer of the colon or rectum (colorectal cancer).

At this time, it is not known whether Eloxatin will improve symptoms of colorectal cancer or help patients live longer. In clinical trials, patients treated with a combination drug regimen of Eloxatin and 5-FU/LV had a longer time before tumor progression and a higher rate of tumor shrinkage.

Eloxatin is currently approved for patients whose cancer has recurred (come back) or advanced following therapy with a combination of 5-FU/LV and irinotecan. Eloxatin is not for patients with newly diagnosed colorectal cancer.

• Eloxatin should not be given to patients with an allergy to platinum compounds. Some signs of an allergic reaction include: rash, hives, swelling of the lips and tongue, and difficulty breathing.
• Eloxatin should not be given to pregnant women or women who are trying to become pregnant, because Eloxatin may cause harm to an unborn child. Women should avoid becoming pregnant while being treated with Eloxatin.

• Eloxatin is not for patients with newly diagnosed colorectal cancer.

Eloxatin is a clear liquid that is given though a drip into a vein.

Eloxatin can cause numbness or tingling in the fingers and toes and around the mouth or throat. This side effect is usually worse if the patient is cold or around cold objects. It can happen a few hours or a few days after treatment. Sometimes the tingling or numbing may not happen with the first treatment but after several treatments. This is known as a cumulative effect and should gradually improve after treatment ends.

Eloxatin can cause a temporary drop in bone marrow function. This can cause

• a drop in white blood cells, increasing the risk of infection
• a drop in red blood cells (anemia), causing tiredness or shortness of breath
• a drop in platelets that results in bruising or bleeding

Patients should contact their doctor if they have:

• difficulty in swallowing
• breathing problems
• vomiting or diarrhea lasting more than 24 hours
• signs of losing much fluid (dehydration) such as:
• decreased urination, dizziness or light-headedness
• dry mouth
• increased thirst
• signs of infection such as:
• redness and swelling at injection site
• fever, sore throat, shivering
• pain when urinating

Other common side effects include:

• tiredness
• nausea
• mouth sores.

Go to FDA's Eloxatin web page at: http://www.fda.gov/cder/drug/infopage/eloxatin

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FDA/Center for Drug Evaluation and Research
Last Updated: August 9, 2002
Originator: OTCOM/DLIS
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