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Drug – Clofarabine Office for Human Research Studies DANA-FARBER / HARVARD CANCER CENTER Clofarabine FDA Approved Risks Associated with Clofarabine Frequent (Between a 10-50% chance that this will happen) Condition in which the number of white blood cells called neutrophils is abnormally low. This increases the risk of infection, which may be serious or life threatening. Low number of platelets, which may cause bleeding and bruising. Bleeding may be serious or life threatening and may required a blood transfusion. Low number of red blood cells that can causes tiredness and shortness of breath. May require a blood transfusion. Loss of appetite and weight loss Any change from the normal heartbeat (abnormal heartbeat) Skin irritation, rash Diarrhea, which is frequent, loose watery stools, which can cause dehydration and may require hospitalization and treatment with intravenous fluids. Severe and prolonged diarrhea can be life-threatening. Bloody nose Feeling tired, tiredness, weakness. Headache High body temperature, a fever. High blood pressure Low blood pressure, which may cause dizziness, lightheadedness or fainting. Liver damage which can cause fatigue, and jaundice (yellowing of the skin and eyes). Although this is usually mild and reversible, this can be serious or life threatening and may require hospitalization and surgery. Feeling sick to the stomach, vomiting Worry Occasional (Between a 1-10% chance that this will happen) Stroke Sudden reddening of the face and/or neck A serious condition that occurs in response to an infection that causes widespread inflammation, resulting in poor blood supply to vital organs (Sepsis). CF Builder Generated Version: 05.27.2016 DFCI IRB Approved Version: 05.20.2016 Drug – Clofarabine Symptoms may include a fast heart rate, fever, confusion and rapid breathing. Sepsis can rapidly lead to a life threatening clinical deterioration. Kidney damage which may cause swelling, may require dialysis Severe skin rash with blisters and can involve the inside of the mouth and other parts of the body Fluid in the organs which may cause low blood pressure, shortness of breath, and swelling of ankles Rare (Less than a 1% chance that this will happen) Damage to the bone marrow (irreversible) which may cause infection, bleeding, and may require blood transfusions -2-