CAPECITABINE ORAL (XELODA) BOXED WARNING XELODA Warfarin Interaction: Patients receiving concomitant capecitabine and oral coumarinderivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. A clinically important XELODA-Warfarin drug interaction was demonstrated in a clinical pharmacology trial. Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon. Postmarketing reports have shown clinically significant increases in prothrombin time (PT) and INR in patients who were stabilized on anticoagulants at the time XELODA was introduced. These events occurred within several days and up to several months after initiating XELODA therapy and, in a few cases, within 1 month after stopping XELODA. These events occurred in patients with and without liver metastases. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy. BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP KIDNEY DISEASE. * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * Take this medicine WITH food, a meal, or a snack. Do not take on an empty stomach. WARNINGS/PRECAUTIONS: TOP * This medicine is CONTRAINDICATED for use during pregnancy. CALL YOUR DOCTOR IMMEDIATELY IF PREGNANT or intend to become pregnant. * Women of childbearing potential and men must use effective CONTRACEPTION during treatment * If nausea and vomiting occurs, do not discontinue taking medication unless advised by your doctor. * Inform your doctor if you are taking the vitamin folic acid or the drug coumadin (WARFARIN). * Notify your doctor if signs of INFECTION develops (eg, fever, sore throat, chills, or unusual bruising or bleeding). * If DIARRHEA develops/persists and is severe or lasts more than 2 or 3 days, call your doctor. * Discontinue medication if painful rash and swelling occur on hands and/or feet that affects daily activities * Notify a doctor immediately if any unusual bleeding or symptoms occur (bruising, petechiae, blood in urine, nose-bleeds, black stools etc.) * Discontinue medication if painful rash, edema or ulcers occur in mouth or on tongue. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Diarrhea; Nausea; Redness & swelling of the hands & feet; Vomiting; Mouth ulcers. Other Common Side Effects: TOP Abnormal blood cell count; Stomach discomfort or pain; Unusual tiredness or weakness; Decreased appetite; Anemia; Increased thirst; Fever; Change in taste; Very high bilirubin level; Changes in urination frequency or amount; Constipation; Gastric or intestinal ulcers; Indigestion; Baldness; Skin inflammation; Skin ulcer; Skin rash; Itching; Skin redness; Chest pain; High blood pressure; Low blood pressure; Rapid heart rate; Headache; Narrowing of tear duct; Eye inflammation; Muscle weakness; Feeling uncoordinated; Swelling of feet or lower legs; Clotting within a blood vessel; Abnormally low platelet count; Liver problems; Coagulation disorders; Supression of blood cell production; Low potassium level; Low magnesium level; High triglycerides level; Flu-like symptoms; Cough; Dizziness; Depression; Confusion; Worsening of asthma. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved