interaction between irinotecan and coumadin. If you have any bleeding or bruising, you should let your physician know. There have been deaths reported from these combinations of side effects. Although the risk of death is low, you should tell your doctor immediately if you experience any of these side effects. Reproductive Irinotecan has been shown to cause birth defects in animals. To avoid risk to the fetus, it is important that you not become pregnant during the conduct of this study. It is also advised that study participants (or their female sexual partner) not become pregnant for one week after injection of the study drug. Avoiding sexual activity is the only certain method to prevent pregnancy. However, if you choose to be sexually active, you should use an appropriate “double barrier” method of birth control (such as female use of a diaphragm, intrauterine device (IUD), or contraceptive sponge, in addition to male use of a condom) or the female should be using prescribed “birth control” pills, injections, or implants. If you choose to be sexually active during this study, you should understand that even with use of these birth control measures, pregnancy could still result. The risks of receiving the study drug while pregnant include potential loss of pregnancy or possible birth defects. Irinotecan given in the dose and frequency used in this study may make it harder for a woman to become pregnant or for a man to cause a woman to become pregnant even after the chemotherapy has been completed. There is not enough information about irinotecan in men and woman of childbearing age who subsequently try to have children to know how likely problems will be.
As with any experimental procedure, there may be adverse events or side effects that are currently unknown and certain of these unknown risks could be permanent, severe, or life threatening. Risks of antibiotic treatments to prevent pneumocystis pneumonia (3/14/05) Risks of oral trimethoprim- sulfamethoxazole : Common (occurring in 10-25% of people) Nausea, Loss of appetite Vomiting Skin rash Uncommon (1-10 of 100 patients ) Low white blood cell counts Low blood platelet counts (problems with blood clotting) Liver irritation resembling hepatitis Low red cell counts, Abnormalities in blood tests that measure liver functions Rare (less than 1 out of 100 patients) Stevens-Johnson syndrome (a severe skin reaction similar to a bad burn that can involve the lining of the mouth and eye) Very low white cell counts, platelet counts, red cell counts Allergic reaction similar to severe asthma with difficulty breathing Life threatening injury to the liver or kidneys Risks of aerosolized pentamidine Common (more than 10 of 100 patients) Nausea Loss of appetite Bronchospasm (difficulty breathing due to squeezing closed breathing passages in the lungs) Cough Shortness of breath Dizziness Rash Uncommon (1-10 out of 100 patients) Headache Rare (less than 1 in 100 patients) Abnormal heart rhythms Low white blood cell counts Low blood sugar
High blood sugar Pancreatitis (inflammation of the pancreas causing belly pain)
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- Summer '07
- Chemotherapy, Bone marrow