Single Patient IND



Capecitabine

FDA Approved

Risks Associated with Capecitabine

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

• Low number of white blood cells which 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.

• Loss of appetite and weight loss

• 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.

• Numbness and tingling in arms, hands, legs or feet.

• Build up of fluid in the body or extremities causing swelling.

• Feeling tired, tiredness, weakness.

• High body temperature, a fever.

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

• Feeling sick to the stomach

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

• Vomiting

• Pain

• Blisters on the skin

• 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) which may be serious or life-threatening.

• Difficulty passing stool

• Dry eye

• Muscle spasms, body aches

• Restlessness, irritability

• Swelling of the face, fingers and lower legs

• Difficulty with balancing

Rare (Less than a 1% 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.

• Loss of muscle coordination including awkward, unsteady walking

• Damage to the heart

• Bleeding internally which may require hospitalization and surgery

• Speech problems

• Vision loss or vision changes that may be reversible.

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DANA-FARBER / HARVARD CANCER CENTER

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