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Patient Prescribing Information
Safety First 
Before you start exploring, take the time to read the side effect information.
Safety First
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.
Are you considering XELODA? Learn more ›
Who is XELODA for?
XELODA is used to treat:
- 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:
- Take a blood thinner, such as warfarin (COUMADIN)
- Take phenytoin (DILANTIN®)
- 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
- 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* — if you have an additional 4 bowel movements each day beyond what is normal or any diarrhea at night
- 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?
- Stomach area pain* or upset stomach
- Constipation*
- Loss of appetite*
- Too much water loss from the body (dehydration)*
- Rash or dry, itchy, discolored skin
- Nail problems
- Hair loss
- Tiredness or weakness
- Dizziness or headache
- Fever
- 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 docetaxel or other medicines.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please be sure to talk with your doctor if you have any questions about your cancer or treatment.
Please see the full Prescribing Information for Additional Important Safety Information.
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