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ORENCIA(R) (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review
Date:8/19/2007

fore the age of 16 and may affect up to 1 child in every 1,000 in the United States.

Important Safety Information about ORENCIA(R) (abatacept)

Before receiving treatment with ORENCIA individuals should tell their doctor if they are taking a TNF blocker (e.g., Enbrel(R), Humira(R), Remicade(R)) to treat rheumatoid arthritis (RA). ORENCIA should not be taken with these medications because of a higher chance of getting a serious infection. Individuals should also tell their doctor if they are taking Kineret(R) to treat RA. ORENCIA should not be taken with Kineret. People taking ORENCIA should notify their doctor if they are taking any other medications including hormones, over-the-counter medicines, vitamins, supplements or herbal products.

Individuals should let their doctor know if they have any kind of infection including an infection that is in only one place of the body (such as an open cut or sore) or an infection that is in the whole body (such as the flu). Having an infection could increase the risk for serious side effects from ORENCIA. It is also important for individuals to let their doctor know if they have an infection that won't go away or a history of infections that keep coming back.

People who have had tuberculosis (TB), a positive skin test for TB, recent close contact with someone who has had TB or develop any of the symptoms of TB (a dry cough that doesn't go away, weight loss, fever, night sweats) should call their doctor right away. Before starting treatment with ORENCIA, a doctor may examine the individual for TB or perform a skin test.

In addition, individuals should let their doctor know if they are scheduled to have surgery or any vaccination or have recently received a vaccination. People should inform their doctor if they have a history of chronic obstructive pulmonary (lung) disease (COPD). Taking ORENCIA may cause COPD symptoms to get worse.

People who have diabetes and use a blood glucose monitor to che
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SOURCE Bristol-Myers Squibb Company

Copyright©2007 PR Newswire.

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