Capecitabine

Pronunciation

Generic Name: capecitabine (KAP-e-SYE-ta-been)
Brand Name: Xeloda

Serious and sometimes fatal bleeding problems have happened when capecitabine was taken with certain anticoagulants (eg, phenprocoumon, warfarin). Bleeding problems have happened during therapy and for up to 1 month after stopping therapy with capecitabine. This risk is greater in patients with cancer and those who are 60 years and older. If you take an anticoagulant while taking capecitabine, talk with your doctor. Your doctor may need to perform frequent blood tests to monitor how your blood is clotting. Be sure to keep all doctor and lab appointments while using capecitabine. Contact your doctor immediately if you develop any signs of bleeding problems, such as unusual bleeding, bruising, or black, tarry stools.


Capecitabine is used for:

Treating certain types of breast, colon, or colorectal cancer in some patients. It may be used alone or with other medicines in some cases.

Capecitabine is an antimetabolite. It works by interfering with the production of proteins necessary for cancer cell growth and reproduction.

Do NOT use capecitabine if:

  • you are allergic to any ingredient in capecitabine or to 5-fluorouracil
  • you have severe kidney problems or a deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD)

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using capecitabine:

Some medical conditions may interact with capecitabine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription (particularly blood thinners) or nonprescription medicine, herbal preparation, or dietary supplement (vitamin E, aspirin, ibuprofen, naproxen)
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of heart, kidney, or liver problems; bone marrow problems; or pain, redness, swelling, tingling, or tenderness of the palms of the hands or soles of the feet (hand-and-foot syndrome)
  • if you have nausea, vomiting, diarrhea, inflammation or sores in the mouth, or an infection
  • if you are undergoing chemotherapy or radiation therapy, or if you take folic acid or vitamins that contain folic acid

Some MEDICINES MAY INTERACT with capecitabine. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Certain anticoagulants (eg, phenprocoumon, warfarin) because the risk of bleeding may be increased by capecitabine
  • Leucovorin because the risk of severe intestinal problems, diarrhea, and dehydration may be increased
  • Hydantoins (eg, phenytoin) because their side effects may be increased by capecitabine

This may not be a complete list of all interactions that may occur. Ask your health care provider if capecitabine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use capecitabine:

Use capecitabine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with capecitabine. Talk to your pharmacist if you have questions about this information.
  • Take capecitabine with food or within 30 minutes after a meal.
  • Swallow capecitabine whole with water. Do not break, crush, or chew before swallowing.
  • It is recommended to use gloves and safety glasses to avoid exposure in case a tablet breaks. If powder from a broken tablet comes into contact with skin, wash the skin immediately with soap and water. If powder comes into contact with your mouth, nose, or eyes, rinse thoroughly with water.
  • If you miss a dose of capecitabine, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Check with your doctor if you miss a dose.

Ask your health care provider any questions you may have about how to use capecitabine.

Important safety information:

  • Capecitabine may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Capecitabine may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking capecitabine. Vaccinations may be less effective.
  • Diarrhea is common with capecitabine. Some cases of diarrhea may cause dehydration and kidney problems that can sometimes be deadly. Do not try to treat diarrhea without first checking with your doctor. Call your doctor right away if the number of bowel movements you have in a day increases by 4 or more than is normal for you. Call your doctor right away if you have bloody diarrhea, severe stomach pain, and fever.
  • Dehydration has happened in people taking capecitabine. Dehydration may cause serious kidney problems that can be fatal. The risk may be increased in people who already have kidney problems or who are taking medicines that can cause kidney problems. The risk may also be increased in people who have loss of appetite, nausea, vomiting, diarrhea, or weakness. Discuss any questions or concerns with your doctor.
  • If you have nausea, vomiting, diarrhea, or loss of appetite, talk with your doctor. There may be ways to lower these side effects.
  • Very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. They can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Heart problems (eg, heart attack, heart failure, irregular heartbeat) and sudden death have happened with capecitabine. These effects may be more common in people who have a history of heart disease. Discuss any questions or concerns with your doctor,
  • Tell your doctor or dentist that you take capecitabine before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests may be performed while you take capecitabine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Talk with your doctor about using an effective method of birth control while taking capecitabine.
  • Use capecitabine with caution in the ELDERLY; they may be more sensitive to its effects.
  • PREGNANCY and BREAST-FEEDING: Capecitabine has been shown to cause harm to the fetus. Do not become pregnant while you are taking it. Talk with your doctor about using effective methods of birth control while taking capecitabine. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking capecitabine while you are pregnant. It is not known if capecitabine is excreted in breast milk. Do not breast-feed while taking capecitabine.

Possible side effects of capecitabine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back, joint, or muscle pain; constipation; dizziness; eye irritation; headache; itchy or dry skin; loss of appetite; mild nausea, vomiting, or diarrhea; stomach pain; taste changes; tiredness; trouble sleeping; upset stomach; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bloody diarrhea; chest, jaw, or left arm pain; decreased amount of urine; discolored skin; dry mouth or eyes; fainting; fast or irregular heartbeat; fever higher than 100.5 degrees F, chills, or sore throat; hair loss; increased thirst; leg pain or swelling; moderate, severe, or persistent nausea, vomiting, or diarrhea; mood or mental changes (eg, depression); nail problems; numbness of an arm or leg; numbness, pain, tingling, blistering, swelling, or redness in the palms of the hands or soles of the feet; pain, redness, swelling, or sores in the mouth or throat; persistent cough or wheezing; shortness of breath; sudden, severe headache or vomiting; sudden, unusual weight gain; swelling in the legs, ankles, or feet; unusual bleeding or bruising; unusual tiredness or weakness; vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of capecitabine:

Store capecitabine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep capecitabine out of the reach of children and away from pets.

General information:

  • If you have any questions about capecitabine, please talk with your doctor, pharmacist, or other health care provider.
  • Capecitabine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take capecitabine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about capecitabine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to capecitabine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using capecitabine.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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