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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

ck their sugar levels should tell their doctor. The infusion of ORENCIA contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day the infusion is received. The doctor may recommend a different monitor.

Women who are pregnant, planning to become pregnant or are thinking about becoming pregnant should tell their doctor. It is not known if ORENCIA(R) (abatacept) can harm an unborn baby. Women who are breast feeding should also inform their doctor. They will need to decide to either breast-feed or receive treatment with ORENCIA, but not both.

Important Information about Side Effects with ORENCIA

Like all medicines that affect your immune system, ORENCIA can cause serious side effects. The possible serious side effects include serious infections and allergic reactions. Also, rare cases of certain kinds of cancers have been reported.

People taking ORENCIA are at increased risk for developing infections including pneumonia, and other infections caused by viruses, bacteria, or fungi. Individuals should call their doctor immediately if they feel sick or get any infection during treatment with ORENCIA.

Allergic reactions are usually mild or moderate, generally occur within the first 24 hours of an infusion, and include hives, swollen face, eyelids, lips, tongue, throat, or trouble breathing. There have been some serious allergic reactions reported after receiving an infusion of ORENCIA.

There have been rare cases of certain kinds of cancer. The role of ORENCIA in the development of cancer is not known.

The more common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea.

For Full Prescribing Information, please visit http://www.ORENCIA.com or http://www.bms.com

Dosing and Administration

ORENCIA is administered by a healthcare pr
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SOURCE Bristol-Myers Squibb Company

Copyright©2007 PR Newswire.

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