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FDA Approves Nulojix for Kidney Transplant Patients
Date:6/15/2011

to Epstein-Barr virus (EBV), the cause of mononucleosis. Transplant patients who have not been exposed to EBV have more difficulty mounting an effective immune response to the virus if they get infected after transplant; typically they get exposed to the virus at time of transplant, as it is carried in around 80 percent of donated organs. Patients should be tested for EBV and should only receive Nulojix if the test shows they have already been exposed to EBV. Another Boxed Warning on the Nulojix label, as well as labels for other immunosuppressants, warns of an increased risk of serious infections and other cancers.

Common adverse reactions observed in transplant patients in the trials included low red blood count (anemia), constipation, kidney or bladder infection, and swollen legs, ankles, or feet. Any transplant patients, including those receiving Nulojix, should limit the amount of time spent in sunlight because of the risk of skin cancer and should not get live vaccines because of the risk of infection.

More than 89,000 patients are waiting for a kidney transplant in the United States, according to the Organ Procurement and Transplantation Network, which is overseen by HHS' Health Resources and Services Administration.

Nulojix is marketed by Princeton, N.J.-based Bristol-Myers Squibb Company.

For More Information:

Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

National Institute of Diabetes and Digestive and Kidney Diseases

http://www2.niddk.nih.gov/

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also i
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SOURCE U.S. Food and Drug Administration
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