Xeloda

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What is Xeloda used for?

Xeloda is used to treat:

• cancer of the colon or rectum that has spread to other parts of the body (metastatic colorectal cancer) when fluoropyrimidine therapy alone is preferred. Patients and physicians should note that combination chemotherapy has shown a survival benefit compared to 5-fluorouracil (5-FU)/oral leucovorin (LV) alone. A survival benefit over 5-FU/LV has not been demonstrated with Xeloda monotherapy.

• breast cancer that has spread to other parts of the body and has not responded to treatment with certain other medicines. These medicines include paclitaxel (Taxol) and anthracycline-containing therapy such as Adriamycin and doxorubicin.

Xeloda is changed in the body to the substance 5-fluorouracil. In some patients with colon, rectum or breast cancer, this substance stops cancer cells from growing and decreases the size of the tumor.

Who should not take Xeloda?

• You should not take Xeloda if you are allergic to 5-fluorouracil (5-FU), because Xeloda is converted by the body to 5-FU.
• You should not take Xeloda if you have severe renal impairment.
• You should not take Xeloda if you are nursing a baby.  Xeloda may pass into the milk and harm the baby.

Special Warnings with Xeloda:

• Xeloda can cause diarrhea, which may be severe. If you have more than 4 bowel movements a day, or diarrhea at night, stop taking Xeloda and contact your doctor.
• Patients over 80 may have more gastrointestinal (diarrhea, nausea, and vomiting) side effects.
• Xeloda may cause harm to the fetus. Do not become pregnant while taking Xeloda. Women should use effective birth control. Men should also practice birth control measures while taking Xeloda.
• Tell your doctor if you are taking a drug that affects blood clotting such as Coumadin or warfarin. There have been reports to the FDA after Xeloda became available to the patient of changes in blood clotting and/or bleeding in people taking Xeloda together with certain anticoagulants (blood thinners). See your doctor regularly for monitoring.

General Precautions with Xeloda:

What should I tell my doctor or health care provider?

Tell your doctor if you:

• take a blood thinner such as warfarin (Coumadin®).  Xeloda may increase the effect of the blood thinner. Your doctor will need to test your blood more often and adjust the dose of your blood thinner if needed.
• take phenytoin (Dilantin®).  Your doctor will need to test your blood more often and adjust the dose if needed.
• are pregnant.
• have kidney problems.
• have liver problems.
• take the vitamin, folic acid.

What are some possible side effects of Xeloda?

(This is NOT a complete list of side effects reported with Xeloda. Your health care provider can discuss with you a more complete list of side effects.)

• Diarrhea (see warnings)
• Nausea: Stop taking Xeloda and contact your doctor if you are not able to eat or only able to eat at certain times.
• Vomiting: Stop taking Xeloda and contact your doctor if you vomit 2-5 times or more in a 24-hour period.
• Sores in mouth and throat: Stop taking Xeloda and contact your doctor if you have painful swelling and ulcers in your mouth or tongue.
• Stomach pain
• Decreased appetite
• Dehydration
• Hand-and-foot syndrome (see general precautions)
• Rash
• Dry or itchy skin
• Tiredness
• Dizziness
• Headache
• Fever: Contact your doctor if you have a fever of 100.5 or higher.

These side effects may differ when taking Xeloda in combination with Taxotere. Please consult your doctor for possible side effects that may be caused by taking Xeloda with Taxotere.

For more detailed information about Xeloda, ask your health care provider.

Link to Xeloda's approved label and patient information

Updated: 11/22/99
Revised: 7/25/00
Revised: 12/15/00

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