GENERIC NAME: CAPECITABINE - ORAL (cap-eh-SIT-uh-bean)
BRAND NAME(S): Xeloda
WARNING: Capecitabine may interact with "blood thinners" (anticoagulants such as warfarin or phenprocoumon) and cause serious, rarely fatal bleeding. In some cases, this bleeding has occurred up to one month after stopping capecitabine as well as during treatment.
If you are using an anticoagulant, your laboratory tests (INR/PT) will be closely monitored. Report any signs of bleeding or bruising (such as black stools) to your doctor immediately.
USES: Capecitabine is used alone or with other treatments/medications to treat certain types of cancer (e.g., of the breast, colon, rectum). It works by slowing or stopping cancer cell growth and by decreasing tumor size.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking capecitabine and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Take this medication by mouth, usually twice daily in the morning and evening or as directed by your doctor. It is best to take this with a full glass of water (8 ounces or 240 milliliters) within 30 minutes after the end of a meal. Capecitabine is usually taken every day for 2 weeks, then stopped for 1 week. This course of treatment may be repeated as directed by your doctor.If you take any antacid products that contain aluminum or magnesium, take capecitabine 2 hours before or after taking any antacids because these products may change the way your body absorbs capecitabine.The dosage is based on your medical condition, body size, and response to therapy. You may be taking a combination of different tablet sizes. Pay close attention to your dose and tablet sizes to avoid over- or under-dosing.Do not increase your dose or take this medication more often than directed without your doctor's approval. Your condition will not improve any faster, and the risk of serious side effects may increase.Since this drug can be absorbed through the skin, women who are pregnant or who may become pregnant should not handle this medication.
SIDE EFFECTS: Nausea, vomiting, loss of appetite, constipation, tiredness, weakness, back/joint/muscle pain, headache, dizziness, trouble sleeping, skin darkening, or dry/itchy skin may occur. Nausea and vomiting can be severe. Changes in diet and lifestyle, such as eating several small meals or limiting activity, may lessen some of these effects. If any of these effects continue or worsen, notify your doctor.Temporary hair loss may occur. Normal hair growth should return after treatment has ended. Temporary nail changes may occur, which may rarely include fungal infections in the nail beds.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Diarrhea is a common side effect of this medication. It may become very severe (possibly fatal). To decrease this side effect, your doctor may prescribe medication (e.g., loperamide) to control your symptoms, replace lost fluids by vein, or stop treatment with capecitabine. Drink plenty of fluids to prevent serious problems due to a loss of too much body water (dehydration). If you experience signs of severe diarrhea (e.g., 4 or more stools per day, diarrhea at night, bloody stools), or if you experience signs of dehydration (e.g., dizziness, decreased amount of urine), stop taking this drug and tell your doctor immediately.Stop taking capecitabine and tell your doctor immediately if you have any of these serious side effects: severe nausea/vomiting (vomiting 2 or more times per day, inability to eat or keep food/fluids in your stomach), painful redness/swelling/sores in mouth or throat.If any of the above symptoms occur, your doctor may lower your dose when you start taking capecitabine again or may stop treatment with this drug.Treatment with capecitabine may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome (palmar-plantar erythrodysesthesia). You can prevent or reduce these problems by protecting your hands and feet from a great deal of heat or pressure. Avoid unnecessary exposure to heat (e.g., hot dishwater, long hot baths). Avoid pressure on elbows, knees, and soles of feet (e.g., leaning on elbows, kneeling, long walks). Wear loose clothing. Depending on how severe your hand-foot syndrome is, your doctor may prescribe a medication to reduce the symptoms or decrease/delay your next dose of capecitabine. If you experience pain/swelling/redness, blisters, or numbness of the hands/feet that affects your usual activities, stop taking this medication and tell your doctor immediately.This medication can lower your ability to fight an infection. Stop taking this medication and call your doctor promptly if you develop any signs of an infection such as high fever, chills, or persistent sore throat.Tell your doctor immediately if you have any of these unlikely but serious side effects: abdominal/stomach pain, unusual bruising or bleeding, extreme tiredness, mental/mood changes (e.g., depression), swelling of the ankles/feet, vision changes, shortness of breath, change in the amount of urine, dark urine, yellowing of the eyes/skin, fast/irregular heartbeat.Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, fainting, jaw/left arm pain.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other side effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking capecitabine, tell your doctor or pharmacist if you are allergic to it; or to 5-fluorouracil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease, a certain enzyme deficiency (dihydropyrimidine dehydrogenase deficiency).Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., bone marrow suppression), heart problems (e.g., coronary artery disease, heart failure), kidney problems, liver problems.Wash your hands well to prevent the spread of infections.Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use an effective sunscreen and wear protective clothing when outdoors. This will also help protect you from problems related to heat (hand/foot syndrome). See Side Effects section for more information.To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports. Use a soft-bristle toothbrush to lower the risk of bleeding gums.Caution is advised when this drug is used in the elderly because they may be more sensitive to the side effects of this medication, especially nausea, vomiting, and diarrhea.This drug is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women use two effective forms of birth control (e.g., condoms and birth control pills) while taking this medication.It is not known if this drug passes into breast milk. Because of possible harm to the nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
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DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: folic acid (including multivitamins with folic acid), leucovorin, metronidazole, tinidazole.This drug can change the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include: "blood thinners" (e.g., warfarin), fosphenytoin, phenytoin.If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting capecitabine.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., bilirubin levels, complete blood counts, kidney and liver function tests) should be performed regularly to monitor your progress and check for side effects.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) in a tightly closed container away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.