Generic Name: capecitabine (KAP-e-SYE-ta-been)
Brand Name: Xeloda
Serious and sometimes fatal bleeding problems have happened when Xeloda was taken with certain anticoagulants (eg, phenprocoumon, warfarin). Bleeding problems have happened during therapy and for up to 1 month after stopping therapy with Xeloda. This risk is greater in patients with cancer and those who are 60 years and older. If you take an anticoagulant while taking Xeloda, 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 Xeloda. Contact your doctor immediately if you develop any signs of bleeding problems, such as unusual bleeding, bruising, or black, tarry stools.
Xeloda 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.
Xeloda is an antimetabolite. It works by interfering with the production of proteins necessary for cancer cell growth and reproduction.
Do NOT use Xeloda if:
- you are allergic to any ingredient in Xeloda or to 5-fluorouracil
- you have severe kidney problems or you have been told that you lack the enzyme dihydropyrimidine dehydrogenase (DPD)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Xeloda:
Some medical conditions may interact with Xeloda. 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 Xeloda. 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 Xeloda
- 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 Xeloda
This may not be a complete list of all interactions that may occur. Ask your health care provider if Xeloda 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 Xeloda:
Use Xeloda as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Xeloda. Talk to your pharmacist if you have questions about this information.
- Take Xeloda with food or within 30 minutes after a meal.
- Swallow Xeloda 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 Xeloda, 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 Xeloda.
Important safety information:
- Tell your doctor or dentist that you take Xeloda before you receive any medical or dental care, emergency care, or surgery.
- Xeloda 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.
- Xeloda 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 Xeloda. Vaccinations may be less effective.
- Diarrhea is common with Xeloda. 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 Xeloda. 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 Xeloda. These effects may be more common in people who have a history of heart disease. Discuss any questions or concerns with your doctor,
- Patients who lack the enzyme dihydropyrimidine dehydrogenase (DPD) in the body are at increased risk of severe and sometimes fatal side effects. These include mouth irritation or sores, diarrhea, low white blood cell counts, or nerve problems. Discuss any questions or concerns with your doctor.
- Lab tests may be performed while you take Xeloda. 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 Xeloda.
- Use Xeloda with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: Xeloda 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 Xeloda. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Xeloda while you are pregnant. It is not known if Xeloda is excreted in breast milk. Do not breast-feed while taking Xeloda.
Possible side effects of Xeloda:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
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.
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; 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 wheezing; shortness of breath; sudden, severe headache or vomiting; sudden, unusual weight gain; swelling in the legs, ankles, or feet; symptoms of infection (eg, fever, chills, sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, painful urination, mouth sores, wound that will not heal); 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 Xeloda:
Store Xeloda 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 Xeloda out of the reach of children and away from pets.
- If you have any questions about Xeloda, please talk with your doctor, pharmacist, or other health care provider.
- Xeloda 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 Xeloda 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 Xeloda. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Xeloda. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Xeloda.
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.