DECITABINE INJ (DACOGEN) BEFORE USING THIS MEDICINE: Tell your doctor: TOP If you are PREGNANT; If you are BREAST FEEDING. Tell your doctor if you are having any of the following conditions: TOP KIDNEY DISEASE; LIVER PROBLEMS. * 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 * This medicine is given as an IV INFUSION at a constant rate over a period of time as recommended by manufacturer. * Follow manufacturer's directions to properly reconstitute. * Proper procedures for handling and disposal should be used. Gloves and other protective clothing to prevent skin contact is recommended. WARNINGS/PRECAUTIONS: TOP * This medicine is CONTRAINDICATED for use during pregnancy. CALL YOUR DOCTOR IMMEDIATELY IF PREGNANT or intend to become pregnant. * If your sexual partner is or may become pregnant, avoid exposing partner to your semen. You must use condom. * Pregnancy should be avoided in women taking this medicine. Use barrier contraceptives in combination with other methods of contraception. * It is important that your doctor monitors your BLOOD STUDIES at regular intervals. * Pediatric: The safety or efficacy of this medicine in pediatric patients below 18 years of age has not been established. * Patients with Hepatic Impairment: Administer with CAUTION to patients with liver disease. * Inform your doctor if you have KIDNEY DISEASE; monitoring of renal function and/or dose adjustment may be necessary. Other Common Side Effects: TOP Abnormal blood cell count; Abnormally low platelet count; Anemia; Fever; Nausea; Constipation; Hemorrhagic spots in the skin; Diarrhea; High blood sugar level; Headache; Difficulty falling asleep; Cough; Vomiting; Swelling of feet or lower legs; Low albumin level; Low magnesium level; Rigors; Pneumonia; Low potassium level; Hemorrhage patches in the skin; Low sodium level; Skin redness; Skin rash; Joint pain; Dizziness; Back pain; Decreased appetite; Inflammation of the pharynx; Cardiac murmur; Very high bilirubin level; Stomach discomfort or pain; High potassium level; Ulcer of mouth and other gi sites; Mouth ulcers; Indigestion; Confusion; Unusual tiredness or weakness; Cellulitis; Enlargement of lymph nodes; Accumulation of abdominal serous fluid; Anxiety; Candidiasis; Partial loss of sensation; Reduction of oxygen supply; Itching; Gingival bleeding; Hemorrhoids; Falls; Injection site infection; Loose stools; Tongue ulceration; Baldness; Chest pain; Urinary tract infection; Transfusion reaction; Difficulty swallowing; Gastro-esophageal reflux; Feeling of general discomfort; Injection site reaction; Inflammation of the sinuses; Severe skin itching with patches; Low blood pressure. 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