About XELODA
Treatment of Advanced Breast and Colorectal Cancers
XELODA (zeh-LOE-duh) is a chemotherapy that's proven to fight certain types of cancer. XELODA is the first FDA-approved oral chemotherapy medication for the treatment of both metastatic breast and colorectal cancers. Unlike some other types of chemotherapy, XELODA can be taken by mouth. This means that patients who take XELODA may not have to go to their doctor's office or a clinic to get intravenous (IV) treatment. Some patients may still need other IV medicines as part of their cancer therapy. But with XELODA, there's 1 less medication they have to wait for.

What XELODA (capecitabine) is Used For

In patients with Breast Cancer, XELODA is used to treat:
  • Breast cancer that has spread to other parts of the body, taken together with another medicine called Taxotere® (docetaxel).1 This type of cancer is called metastatic breast cancer.
  • Breast cancer that has spread to other parts of the body and has not improved after treatment with other medicines. These include paclitaxel and anthracycline-containing medicines such as Adriamycin (doxorubicin)2.

 

In patients with Colorectal Cancer, XELODA (capecitabine) is used to treat

  1. Dukes' C (Stage III) colon cancer after surgery (called "adjuvant therapy")
  2. Cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body. This is called 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 with XELODA, XELODA was no worse than 5-FU and leucovorin taken together. But it did not improve survival compared to these 2 medicines.
 

How XELODA (capecitabine) Works

The generic name for XELODA is capecitabine ("CAPE-site-ah-bean"). XELODA is a medicine you take by mouth (orally). XELODA is changed in the body to a substance called 5-fluorouracil (5-FU). In some patients with colon, rectum, or breast cancer, 5-FU stops cancer cells from growing and decreases the size of the tumor.
 
 

XELODA and Health Insurance Coverage

Most third-party payers, including HMO plans, managed care organizations, indemnity plans and others, provide coverage for XELODA. XELODA is also covered by Medicare.
 
 
Indications:
XELODA is used to treat:
 
Important Safety Information:
WARNING:
XELODA may increase the effect of other medicines used to thin your blood such as warfarin (COUMADIN®). It is very important that your doctor knows if you are taking a blood thinner such as warfarin because XELODA may increase the effect of this medicine and could lead to serious side effects. If you are taking blood thinners and XELODA, your doctor needs to check more often how fast your blood clots and change the dose of the blood thinner, if needed.
 
  • The most common side effects of XELODA are: 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 hand-and-foot syndrome (palms of the hands or soles of the feet tingle, become numb, painful, swollen or red); 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 (TAXOTERE). 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.
 
Please see accompanying patient information and complete Prescribing Information.
 
Adriamycin is a trademark of Pharmacia & Upjohn Company.
Coumadin is a registered trademark of Bristol-Myers Squibb Company.
Taxol is a registered trademark of Bristol-Myers Squibb Company.
Taxotere is a registered trademark of Sanofi-Aventis U.S. LLC.
 
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For more information about XELODA, contact your physician or other healthcare professional.