Single Patient IND



Irinotecan

FDA Approved

Risks Associated with Irinotecan

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

• 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.

• A low number of white blood cells may increase the risk of infection. It may become life-threatening. Symptoms of infection may include fever, pain, redness, and/or difficulty breathing.

• 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.

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

• Hairloss

• Loss of appetite and weight loss

• Difficulty passing stool

• Skin irritation, rash

• Dizziness

• Shortness of breath

• Feeling tired, tiredness, weakness.

• Muscle weakness of the whole body

• High body temperature, a fever.

• Feeling sick to the stomach

• Vomiting

• Cough

• Pain

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

• Allergic reaction that may include a rash, hives, fever, difficulty breathing, and low blood pressure. Although usually reversible with treatment, it can be severe or life threatening.

• A tear or hole in internal organs that may require surgery.

• Blood clots can form leading to swelling in the arms and legs. These clots can travel to the lungs causing shortness of breath or to the brain causing a stroke. This may be serious or life threatening.

• Damage to the heart

• Scarring of the lungs that can affect your ability to breath and may make you short of breath. This may be serious or life threatening.

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DANA-FARBER / HARVARD CANCER CENTER

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