Single Patient IND - Harvard University
Tacrolimus
FDA Approved
Risks Associated with Tacrolimus
Frequent (Between a 10-50% chance that this will happen)
• 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.
• 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.
• Hairloss
• 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
• Build up of fluid in the body or extremities causing swelling.
• Headache
• Excess sugar in the blood, if severe may require hospitalization and urgent treatment. (diabetes)
• High body temperature, a fever.
• High blood pressure
• Difficulty sleeping or falling asleep; unable to sleep
• Kidney failure, which is when both of your kidneys fail and your body holds fluid which can be serious or life threatening. Your blood pressure rises and harmful wastes build up in your body. You may experience fatigue, nausea, and loss of appetite. When this happens, you need treatment to replace the work of your failed kidneys such as dialysis.
• Feeling sick to the stomach, vomiting
• Numbness and tingling in arms, hands, legs or feet.
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.
• Any change from the normal heartbeat (abnormal heartbeat)
• Decreased blood flow to part of the heart causing damage to the heart muscle. This may be serious or life threatening.
• Damage to the brain
• 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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