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Drug – Mitoxantrone Office for Human Research Studies DANA-FARBER / HARVARD CANCER CENTER Mitoxantrone FDA Approved Risks Associated with Mitoxantrone Frequent (Between a 10-50% chance that this will happen) Condition in which the number of white blood cells circulating in the blood is abnormally low. This increases the risk of infection, which may be serious or life threatening. Low number of red blood cells that can causes tiredness and shortness of breath. May require a blood transfusion. Low number of platelets, which may cause bleeding and bruising. Bleeding may be serious or life threatening and may required a blood transfusion. Hairloss 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. Headache Feeling sick to the stomach, vomiting Sores in the mouth and esophagus, which may be painful and cause difficulty swallowing. Pain Occasional (Between a 1-10% chance that this will happen). The heart is not able to pump blood properly, which can cause weakness and tiredness, fluid retention, and fluid build-up in the lungs, which can cause shortness of breath. A reaction at the site where an injection (shot) was given, which may cause some redness and swelling Abnormally high levels of enzymes produced by the liver meaning that your liver is not functioning properly and 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. Changes in color and thickness, darkening of the nail bed, thickening, shedding CF Builder Generated Version: 05.27.2016 DFCI IRB Approved Version: 05.20.2016 Drug – Mitoxantrone Rare (Less than a 1% chance that this will happen) Irregular menstrual periods A second cancer related to the treatment of your first cancer. This usually occurs years after treatment for the first cancer. -2-