Prescribing Information

Patient Prescribing Information

Safety First

Before you start exploring, take the time to read the side effect information.

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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.

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The XELODA Support Program is here for you

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.


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Preparing for office visits

Because you take XELODA at home or work, you may spend less time at office visits. It is especially important to stay in close touch with your healthcare team and prepare for office visits so you make the most of them.

Woman at doctor's office counter working with healthcare team

Working with your healthcare team

Your healthcare team may include:

  • Oncologists, nurse practitioners, physician assistants, surgeons, and radiologists
  • Oncology nurses
  • Pharmacists
  • Psychiatrists, psychologists, social workers, and counselors
  • Dietitians/nutritionists
  • Pain specialists
  • Rehabilitation specialists (occupational/physical therapists)
  • Plastic surgeons (for reconstructive surgery)
  • Other specialists

To get the care you need, it's important to talk openly and honestly with your healthcare team about how you are feeling. It is especially important to tell your team about any side effects or other concerns you have. When you need it, feel free to ask for help managing daily challenges.

Preparing for your office visits

Here are some tips to help you prepare for your office visits:

  • Use your XELODA Treatment Planner to track your dosing schedule and record any side effects you may have. Bring it with you to your appointment.
  • Before your visit, write down your questions. Ask the most important questions first and ask who you should call in case of emergency.
  • Take a notepad with you to the office visit. Write down the answers to your questions. Take notes about any other key points you need to remember so you can research them further later.
  • Ask a family member or friend to go to the office visit with you to be an "extra set of ears."
  • Breast cancer and colorectal cancer treatment can get technical. If you don't understand something, ask your doctor to explain it again, in a different way. Make sure all your questions have been answered.
  • Find out when to call the doctor and when to call the nurse. Some questions can be answered by a nurse or other member of your healthcare team. Ask for their names and numbers and find out the best time to call each person.

Download XELODA Treatment Planner

Working with your healthcare team to understand test results

Here are some things that you can do to help prepare for your test results:

  • Ask your healthcare team when you can expect to get your test results and how you can get them as soon as possible.
  • Call your healthcare team if you don't get your results when you expect to receive them.
  • Write down any questions you have before your office visit. This will help you to discuss your test results and treatment plan going forward.
  • Bring a friend or family member with you when you get your results. They can be another set of ears and a good source of support.
  • Once you have your test results, ask your healthcare team to help you understand what the results mean and what you need to do moving forward.

Learn more about understanding side effects

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:

  • 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.

Please see complete Prescribing Information.

Coumadin is a registered trademark of Bristol-Myers Squibb Company. Dilantin is a registered trademark of Pfizer Inc.

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Before you sign up for the XELODA Support Program

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