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News on Xeloda (capecitabine)

Immunogen: What Really Happened With T-DM1's Filing? - Seeking Alpha (blog)

Immunogen: What Really Happened With T-DM1's Filing?Seeking Alpha (blog)All but one of the patients had been treated with the three most commonly used chemo drugs (or classes of drugs): An anthracycline, a taxane, and Xeloda. ...Why Did My Stock Just Die?Motley FoolFDA denies accelerated approval for trastuzumab-DM1HemOncTodayRoche Cancer Drug Hits RoadblockDaily Marketsall 14 news articles »

The Cancer Market Outlook To 2015: Competitive Landscape, Market Size ... - OfficialWire (press release)

The Cancer Market Outlook To 2015: Competitive Landscape, Market Size ...OfficialWire (press release)Roche was the leading player in the cancer market in 2009, with its leading products Avastin, MabThera, Herceptin, Tarceva and Xeloda. ...

Controlling Health Care Costs: US Versus England - Clinical Oncology News (registration)

Clinical Oncology News (registration)Controlling Health Care Costs: US Versus EnglandClinical Oncology News (registration)... GlaxoSmithKline) in combination with capecitabine (Xeloda, Roche Pharmaceuticals) for women with advanced or metastatic HER2-positive breast cancer. ...

Health Canada Approves Trastuzumab for HER2-Positive Advanced Stomach Cancer - DG News

CBC.caHealth Canada Approves Trastuzumab for HER2-Positive Advanced Stomach CancerDG News... Health Canada has approved trastuzumab (Herceptin), in combination with capecitabine (Xeloda) or intravenous 5-fluorouracil and cisplatin, ...Health Canada approves HERCEPTINĀ® for patients with HER2-positive advanced ...CNW Group (press release)Health Canada approves first targeted biological therapy to show survival ...News-Medical.netall 9 news articles »

Xeloda (capecitabine)

Last updated on: Jan 24, 2007

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. This information is provided by the U.S. Food & Drug Administration. For more information about this drug, click here.

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.
Dukes' C colon cancer in patients who have had complete removal of the tumor when treatment with fluoropyrimidine therapy alone is preferred. Although neither Xeloda nor combination therapy prolongs overall survival, combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone.
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 Concerning 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 side effects such as diarrhea, nausea, and vomiting.

Xeloda may cause harm to your unborn child. 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. After Xeloda became available, there have been reports to the FDA 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 should I tell my doctor or healthcare 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 healthcare 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 are 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?F or higher.

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

This information is provided by the U.S. Food & Drug Administration.
For more information about this drug, click here.