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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Setting a treatment routine

It can be difficult to start a new treatment after learning that you have cancer or hearing that your cancer has progressed. It is important for you to develop a treatment routine that fits into your life. This can help you stick with your treatment schedule and feel more in control.

Using your XELODA Treatment Planner

It is important for you to take XELODA exactly as your healthcare team tells you to. The XELODA Treatment Planner is designed to help you track your dosing schedule and record any side effects you may have.

You can download the treatment planner below.

Staying on track with treatment

Here are some things you can do to make sticking with your treatment plan easier:

  • Ask your healthcare team for written instructions about how and when to take XELODA, especially if your dose is being changed.
  • Know what side effects you can expect at this point in your treatment and how you and your healthcare team will manage them. This can help you feel more prepared and in control.
  • Use your XELODA Treatment Planner to track your dosing schedule and record what side effects you have during your treatment cycle and when they occur. This can help your healthcare team make changes to find the dose that's right for you.
  • Remembering to take your medicine can be difficult. It can help to ask a friend or family member to remind you and check in regularly to see how you are doing with your treatment schedule.
  • Use a pillbox that organizes a week's worth of medicine into daily morning and evening doses.
  • When traveling, take plenty of XELODA with you in its original container and keep it with you. When flying, put your XELODA in a carry-on bag so you always know where it is.
  • Ask your healthcare team for a XELODA Starter Kit, if you didn't get it.

Use your XELODA Treatment Planner to track your dosingschedule and record any side effects you may have.

Download XELODA Treatment Planner

Download A Patient Guide to Oral Medicine for Cancer

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

Are you or someone you care for currently taking
XELODA or have been prescribed XELODA?

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This program is intended for people taking XELODA and
their caregivers. If you or a loved one receives a XELODA
prescription, please come backand register. In the meantime,
you will find a wealth of information at www.XELODA.com.