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Xeloda®

Brand Name: Xeloda®
Active Ingredient:   capecitabine
Strength(s): 150mg and 500mg
Dosage Form(s):   Tablets
Company Name:    Roche Laboratories, Inc.
Availability:         Prescription only
*Date Approved by FDA:   April 30, 1998
*Approval by FDA does not mean that the drug is available for consumers at this time.




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.

    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.
    • 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:   Xeloda can cause tingling, numbness, pain, swelling, or redness in the palms of your hands or soles of your feet (hand and foot syndrome). Stop taking Xeloda and contact your doctor if you have signs of this syndrome. Your doctor may want to decrease your dose or stop your treatment with Xeloda.

    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 http://www.fda.gov/cder/foi/label/1998/20896lbl.pdf    Xeloda's approved label and patient information 

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

     

    Back to Drug Side Effects


    source: FDA


    last update: December 2004





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