RISKS, STRESS OR DISCOMFORT 
Cyclosporine is a very effective drug but may have several side effects. The immediate effects of this drug 
may include nausea or vomiting when given orally. Other side effects include the possibility of developing 
high blood pressure (hypertension), shaking of the hands (tremor), increased hair growth and possibly an 
effect on mental function. These effects are generally reversible upon decreasing the dose of the drug. An 
occasional patient has had a seizure but it is unclear whether cyclosporine, other drugs, or a combination of 
drugs was responsible. Some patients given intravenous cyclosporine for the treatment of GVHD experienced 
painful sensation in hands or feet or both. The pain subsided with the improvement of the GVHD or when 
the cyclosporine was switched from the intravenous to the oral form. 
Because cyclosporine suppresses the immune system, there is a possibility that it could enhance HIV 
replication. 
Patients may experience a change of liver or kidney function, in which case, the dose will be reduced or 
possibly even withheld. This effect on kidneys seems to increase when other drugs which might cause kidney 
problems are given at the same time, especially antibiotics. Occasionally the kidney damage caused may 
require the use of an artificial kidney (hemodialysis). 
Blood samples are drawn frequently to follow the treatment and the course of events. The risk is limited to 
the discomfort at the site of needle insertion, although most of the time blood will be withdrawn through the 
central catheter which is already in place in nearly all patients. 
There may be some as yet unknown consequences of cyclosporine to you (or your embryo or fetus should 
you become pregnant). 
BENEFITS 
This therapy has the potential to prevent and treat GVHD and prolong your life, but it may also be of no 
benefit and may possibly have injurious effects. 
ALTERNATIVES 
You may choose not to have any preventative therapy for GVHD. However, there is considerable potential 
risk if no therapy is used. There are other potential therapies under investigation. 
OTHER INFORMATION 
This study will be conducted as described in the Basic Oncology Consent Form. You will be informed of any 
new findings on the treatment of GVHD. It is understood that all medical expenses relating to, or arising 
from these procedures will be paid by you and/or your insurance company. Financial compensation is not 
available for this treatment or in the event of physical injury or death resulting from this research project. 
Your decision to participate in this study is voluntary and you may withdraw your consent at any time, for 
any reason, without notice and without prejudice. 
In order to evaluate the results of this study, your medical records will need to be available to other 
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Recombinant DNA Research, Volume 15 
