Prescribing Information

Patient Prescribing Information

Safety First

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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.


Are you considering XELODA? Learn more ›

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The importance of taking your treatment

To get the most benefit from your treatment with XELODA, it is important to follow your XELODA treatment routine exactly as your healthcare team has prescribed. If you have difficulties keeping up with your treatment schedule, your healthcare team can help. If you have side effects with XELODA, your healthcare team can make changes to find the dose that is right for you. Never change your dose unless instructed to do so by your doctor or other healthcare team member. If you have side effects that worry you, stop taking XELODA immediately and call your healthcare team right away.

Doctor holding xeloda pill common challenges with sticking to your xeloda treatment plan

Common challenges with sticking to your XELODA treatment plan

Here are some of the common challenges you may face when taking XELODA and some tips to help you stay on track:

  • Challenge: Finding it difficult to remember to take XELODA.
    Suggestion: Ask your healthcare team to provide your treatment plan in writing and use a pillbox to help you stay organized.
  • Challenge: Having trouble paying for XELODA
    Suggestion: The Genentech BioOncology Co-Pay Card Program offers savings on out-of-pocket expenses on XELODA prescriptions to eligible patients.
  • Challenge: Being tired of feeling like a patient and wanting to feel like yourself again.
    Suggestion: Instead of thinking of yourself as a patient, think of yourself as someone who is doing everything possible to fight and take control of cancer.
  • Challenge: Having side effects that are difficult to manage.
    Suggestion: Stop taking XELODA and call your healthcare team right away. Your doctor can adjust your XELODA dose or even interrupt it for a while to help manage side effects. This is a normal part of treatment with XELODA. Always talk with your healthcare team about side effects you have.

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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