Single Patient IND



Idarubicin

FDA Approved

Risks Associated with Idarubicin

Frequent (Between a 10-50% chance that this will happen)

• Low number of platelets, which may cause bleeding and bruising. Bleeding may be serious or life threatening and may required a blood transfusion.

• 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.

• Hairloss

• 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

• Hives

• Redness, pain or peeling of palms and soles

Occasional (Between a 1-10% chance that this will happen)

• Any change from the normal heartbeat (abnormal heartbeat)

• Redness, flaking or sloughing of skin in the radiation treatment area

• 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

• 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.

• Changes in color and thickness, darkening of the nail bed, thickening, shedding

• Sores in the mouth and esophagus, which may be painful and cause difficulty swallowing.

• Loss of nails

• Reddish discoloration of the urine, sweat and saliva

Rare (Less than a 1% chance that this will happen)

• Abnormal kidney function tests, which means the kidneys aren t working properly. When the kidneys do not work properly, wastes can build up in your blood, leading to swelling in the arms and legs, tiredness and weakness. This could become severe, requiring hospitalization and dialysis to clean the wastes out of your blood. If the wastes are not removed from your blood, this could cause seizures and be life threatening.

• A second cancer related to the treatment of your first cancer. This usually occurs years after treatment for the first cancer.

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DANA-FARBER / HARVARD CANCER CENTER

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