Brand Name(s):

• Xeloda®

IMPORTANT WARNING

Capecitabine may cause serious or life-threatening bleeding when taken along with anticoagulants ('blood thinners') such as warfarin (Coumadin®). Tell your doctor if you are taking warfarin. Your doctor will order laboratory tests to monitor how fast your blood clots and may need to change your dose of warfarin. If you experience any of the following symptoms, call your doctor immediately: unusual bleeding; vomiting or spitting up blood or brown material that resembles coffee grounds; bloody or black, tarry stools; blood in urine; red or dark-brown urine; or easy bruising.

WHY is this medicine prescribed?

Capecitabine is used in combination with other medications to treat breast cancer that has come back after treatment with other medications. It is also used alone to treat breast cancer that has not improved after treatment with other medications. Capecitabine is also used to treat colon or rectal cancer (cancer that begins in the large intestine) that has gotten worse or spread to other parts of the body. It is also used to prevent colon cancer from spreading in people who have had surgery to remove the tumor. Capecitabine is in a class of medications called antimetabolites. It works by stopping or slowing the growth of cancer cells.

HOW should this medicine be used?

Capecitabine comes as a tablet to take by mouth. It is usually taken twice a day (in the morning and in the evening) for 2 weeks, followed by a 1 week break before repeating the next dosage cycle. It is usually taken after a meal (within 30 minutes of breakfast and dinner) and with a glass of water. Your doctor will decide how many times you should repeat this cycle. Take capecitabine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take capecitabine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Your doctor may adjust your dose of capecitabine or stop your treatment for a period of time depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

Swallow the tablets whole; do not split, chew, or crush them.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?

Capecitabine is also sometimes used to treat advanced gastric cancer (cancer of the stomach). Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking capecitabine,

• tell your doctor and pharmacist if you are allergic to capecitabine, fluorouracil (Adrucil, 5-FU), any other medications, or any of the ingredients in capecitabine tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: phenytoin (Dilantin), leucovorin, and folic acid (in multivitamins). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Other medications may also interact with capecitabine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have been told that you have or ever had dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (a lack of a naturally occurring enzyme in your body). Your doctor may probably tell you not to take capecitabine.
• tell your doctor if you have or have ever had kidney, liver, or heart disease.
• tell your doctor if you are pregnant or plan to become pregnant. You should not plan to have children while you are taking capecitabine. You should use a reliable method of birth control to prevent pregnancy in yourself or your partner during your treatment with capecitabine. Capecitabine may harm the fetus.tell your doctor if you are breast-feeding. You should not breast-feed during your treatment with capecitabine.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• diarrhea
• nausea
• vomiting
• stomach pain
• fever, chills, sore throat, or other signs of an infection
• black, tarry stools
• red urine
• unusual bruising or bleeding
• unusual tiredness or weakness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to capecitabine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2011.