Indications:

XELODA is used to treat:

• cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic colorectal cancer). XELODA is used as a single drug to treat metastatic colorectal cancer. You should know that in studies, other medicines showed improved survival when they were taken together with 5-FU and leucovorin. In studies, XELODA used as a single drug was no worse than 5-FU and leucovorin taken together, but did not improve survival compared to these two medicines.
• cancer of the colon after surgery.
• breast cancer that has spread to other parts of the body (metastatic breast cancer) together with another medicine called docetaxel.
• breast cancer that has spread to other parts of the body and has not improved after treatment with other medicines such as paclitaxel and anthracycline-containing medicine such as doxorubicin.

Important Safety Information:

• The most common side effects of XELODA are: hand-and-foot syndrome, diarrhea, nausea, vomiting, sores in the mouth and throat (stomatitis), stomach area pain (abdominal pain), upset stomach, constipation, loss of appetite, and too much water loss from the body (dehydration) (These side effects are more common in patients age 80 and older). Other common side effects are rash; dry, itchy or discolored skin; nail problems; hair loss; tiredness; weakness; dizziness; headache; fever; pain (including chest, back, joint and muscle pain); trouble sleeping; and taste problems. Tell your doctor if you have heart problems because you could have more side effects related to your heart.

  These side effects may differ when taking XELODA with docetaxel. Please consult your doctor for possible side effects that may be caused by taking XELODA with other therapies.

  If you are concerned about these or any other side effects while taking XELODA, talk to your doctor.

• Do not take XELODA if you are nursing a baby. Tell your doctor if you are nursing. XELODA may pass to the baby in your milk and harm the baby.

  Women should not become pregnant while taking XELODA. XELODA may harm your unborn child. Use effective birth control while taking XELODA. Tell your doctor if you become pregnant. Men should use birth control while taking XELODA.

  Do not take XELODA if you are allergic to 5-fluorouracil, capecitabine or any of the ingredients in XELODA. Do not take XELODA if you have been told that you lack the enzyme DPD (dihydropyrimidine dehydrogenase).

• Stop taking XELODA immediately and contact your doctor right away if you have the side effects listed below or other side effects that concern you. Your doctor can then adjust XELODA to a dose that is right for you or stop your XELODA treatment for a while. This should help to reduce the side effects and stop them from getting worse.
• • - Diarrhea: if you have an additional 4 bowel movements each day beyond what is normal or any diarrhea at night
  • - Vomiting: if you vomit more than once in a 24-hour time period
  • - Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual
  • - Stomatitis: if you have pain, redness, swelling or sores in your mouth
  • - Hand-and-Foot Syndrome: if you have pain, swelling or redness of your hands or feet that prevents normal activity
  • - Fever or Infection: if you have a temperature of 100.5°F or greater or other signs of infection

Please be sure to talk to your doctor if you have any questions about your condition or treatment.

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For more information about XELODA, contact your physician or other healthcare professional.