What is the most important safety information I should know about XELODA?
It is very important that your doctor knows if you are taking a medicine used to thin your blood, such as warfarin (COUMADIN®). XELODA may increase the effect of this medicine. This 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. He or she will change the dose of the blood thinner, if needed.
The XELODA Support Program, sponsored by Genentech, gives you helpful tips, advice about how to identify and manage side effects, and other information about XELODA based on where you are in your treatment cycle.
Your Support Program benefits will also include phone calls from registered oncology nurses to help you at key points during your treatment cycles. This program is for educational purposes only. It does not take the place of talking to your healthcare team about your medical condition or treatment.
XELODA is used alone for adjuvant treatment in patients with stage III (Dukes' C) colon cancer who have had surgery for their tumor. Adjuvant refers to medicine that is used in addition to surgery. XELODA is prescribed when treatment with fluoropyrimidine therapy alone is preferred.
The FDA approved XELODA for use in stage III (Dukes' C) colon cancer in 2005.
Is XELODA effective?
XELODA has demonstrated long-term efficacy in the adjuvant treatment of Dukes' C (Stage III) colon cancer 1,2
XELODA demonstrated consistent 5-year disease-free survival (cancer did not come back) across most groups analyzed.2
References
Xeloda [package insert]. South San Francisco, CA: Genentech USA, Inc; 2011.
Twelves C, Scheithauer W, McKendrick J, et al. Capecitabine versus 5-FU/LV in stage III colon cancer: updated 5-year effi cacy data from X-ACT trial and preliminary analysis of relationship between handfoot syndrome (HFS) and effi cacy. Presented at: American Society of Clinical Oncology Annual Meeting; May 30-June 3, 2008; Chicago, Illinois (Poster 274).
What are the benefits of XELODA oral chemotherapy treatment for colon cancer?
Since XELODA is a pill you take at home or work and is used alone for adjuvant treatment of colon cancer, it may allow you to reduce the time you spend at office visits. You will still need to make office visits regularly so your healthcare team can assess your treatment and monitor any side effects you may have.
Important safety information for patients taking XELODA alone after colon cancer surgery
Clinical studies have shown that taking XELODA alone may cause serious side effects. These may include liver problems; pain, swelling, or redness in your hands or feet (hand-and-foot syndrome); problems with your immune system, such as neutropenia (low levels of a special type of granulocyte, or white blood cell, called a neutrophil) and low levels of another type of white blood cells, lymphocytes; diarrhea; and painful sores in your mouth (stomatitis).
Cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body.
This is called metastatic colorectal cancer (mCRC). XELODA is used as a single medicine to treat mCRC.
In medical studies, people lived longer when they took other cancer medicines at the same time that they took 5-fluorouracil (5-FU) and leucovorin. In medical studies, XELODA used as a single medicine was no worse than 5-FU and leucovorin taken together. XELODA did not improve survival compared with these 2 medicines.
Cancer of the colon after surgery.
Breast cancer that has spread to other parts of the body.
This is called metastatic breast cancer (mBC). For this kind of breast cancer, XELODA is taken 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. These medicines include paclitaxel and anthracycline-containing medicine such as doxorubicin.
What is the most important safety information I should know about XELODA?
It is very important that your doctor knows if you are taking a medicine used to thin your blood, such as warfarin (COUMADIN®). XELODA may increase the effect of this medicine. This 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. He or she will change the dose of the blood thinner, if needed.
Who should not take XELODA?
Do not take XELODA if:
You are nursing a baby. XELODA may pass through your breast milk and to the baby and harm the baby
You are allergic to the chemotherapy medicines 5-FU and capecitabine or to any of the ingredients in XELODA
Your body doesn't have enough of the enzyme DPD (dihydropyrimidine dehydrogenase)
What should I tell my doctor before taking XELODA?
Tell your doctor if you:
Are pregnant or think you may be pregnant. XELODA may harm your unborn child. Men and women should use effective birth control while taking XELODA
Take a blood thinner, such as warfarin
Take phenytoin (DILANTIN®)
Have kidney, liver, or heart problems
Take folic acid, a B complex vitamin, or a multivitamin containing folic acid
Stop taking XELODA immediately and contact your doctor right away if you have any of these serious common side effects or any other side effects that worry you:
Diarrhea* — at least 4 more bowel movements each day than is normal for you or if you wake up because you need to have a bowel movement
Throwing up (vomiting)* — more than once in 24 hours
Feeling sick to your stomach (nausea)* — if you don't feel like eating and if the amount of food you eat each day is much less than usual
Pain, redness, swelling, or sores in your mouth (stomatitis)*
Hand-and-foot syndrome — pain, swelling, or redness of your hands or feet that prevents normal activity
Fever or infection — a temperature of 100.5°F or higher or other signs of infection
If you do have any of the side effects listed above, or if you have other side effects that worry you, your doctor can change your dose of XELODA or stop your XELODA treatment for a while. This may help to reduce the side effects and stop them from getting worse.
What are the other common side effects of XELODA?
Constipation*
Loss of appetite*
Stomach area pain* or upset stomach
Too much water loss from the body (dehydration)*
Rash or dry, itchy, discolored skin
Nail problems
Hair loss
Tiredness or weakness
Dizziness or headache
Pain, including chest, back, joint, or muscle pain
Trouble sleeping
Problems with your sense of taste
*This side effect is more common in patients 80 years and older.
You may have different side effects if you take XELODA with docetaxel. Please talk with your doctor about possible side effects that may be caused by taking XELODA with other medicines.
Please be sure to talk with your doctor if you have any questions about your cancer or treatment.
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