Single Patient IND



Busulfan

FDA Approved

Risks Associated with Busulfan

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

• A low number of white blood cells that 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.

• Loss of appetite and weight loss

• Any change from the normal heartbeat (abnormal heartbeat)

• Difficulty passing stool

• 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.

• Dizziness

• Heartburn

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

• Feeling tired, tiredness, weakness.

• Pain in the head

• High body temperature, a fever.

• High blood pressure

• 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.

• Difficulty sleeping or falling asleep; unable to sleep

• 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.

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

• Stuffy nose

• Feeling sick to the stomach, vomiting

• Chills and shivering

• Cough

• Anxiety

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

• Condition in which the lens of the eye becomes cloudy. Surgical intervention may be required.

• Abnormal sex hormone production. In pre-menopausal women, underproduction of these hormones may cause menstrual periods to stop (amenorrhea), infertility and vaginal dryness. In men, underproduction of these hormones may result in decreased sperm production and consequent infertility.

• Blood in the urine

• Bleeding internally which may require hospitalization and surgery

• 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.

• Convulsion or seizure

• Vision loss or vision changes that may be reversible.

• Loss or absence of sperm

• Menopause

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

• Collection of fluid around the heart which may cause a life threatening condition where the heart is unable to pump correctly due to the external pressure. This may require medical intervention to drain the fluid and remove the pressure.

• 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.

• Low blood pressure, which may cause dizziness, lightheadedness or fainting.

• 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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