B5B0001C_FS0408_7x9wip5 7/8/08 3:36 PM Page 1
FACTS IMPORTANT ® ABOUT ORENCIA
ORENCIA (abatacept) is a prescription medicine that reduces signs and symptoms in:
• adults with moderate to severe RA, including those who have not been helped enough by other medicines for RA. ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
In RA, ORENCIA can reduce pain and joint inflammation, but it can also make your immune system less able to fight infection. ORENCIA can make you more likely to get infections or make any infection worse. It is important to tell your doctor if you think you have any infections.
BEFORE YOU START ORENCIA
Tell your healthcare professional about all your medical conditions, including if you:
• Have an infection that won’t go away or are prone to infections. If you have an infection when taking ORENCIA, you may have a higher chance for getting serious side effects.
• Have had tuberculosis (TB) or have been in contact with someone who has it. Tell your healthcare professional right away if you get a dry cough that does not go away, weight loss, fever, or night sweats.
• Have or have had viral hepatitis. Before you use ORENCIA, your doctor may examine you for hepatitis.
• Have a history of chronic obstructive pulmonary (lung) disease (COPD).
• Are scheduled to have surgery.
• Are allergic to any of the ingredients in ORENCIA such as: abatacept, maltose, monobasic sodium phosphate, or sodium chloride for administration.
• Recently received a vaccination or are scheduled for any vaccination. If you are receiving ORENCIA, you should not take live vaccines.
• Have diabetes and use a blood glucose monitor. You may get falsely high blood glucose readings with certain types of blood glucose monitors the day you receive an infusion of ORENCIA.
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you have any questions about ORENCIA (pronounced oh-REN-see-ah). RHEUMATOID ARTHRITIS (RA)
RA is a disease of the immune system which causes joint pain and damage, and impacts the ability to perform daily activities.
• Are pregnant or planning to become pregnant. It is not known if ORENCIA (abatacept) can harm your unborn baby. Bristol-Myers Squibb Company has a registry for pregnant women exposed to ORENCIA. The purpose of this registry is to check the health of the pregnant mother and her child. Patients are encouraged to call the registry themselves or ask their doctors to contact the registry for them by calling 1-877-311-8972.
• Are breast-feeding. You will need to decide to either breast-feed or receive treatment with ORENCIA, but not both.
Tell your healthcare professional about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Especially tell your doctor if you take other biologic medicines to treat RA such as:
• Enbrel® (etanercept) • Humira®
• Remicade® • Kineret® • Rituxan®
(adalimumab) (infliximab)
(anakinra) (rituximab)
You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines for your RA.
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new prescription.
IMPORTANT INFORMATION ABOUT POSSIBLE SIDE EFFECTS WITH ORENCIA
ORENCIA can cause serious side effects including:
• Serious infections. Patients receiving ORENCIA have a higher chance of getting infections including pneumonia, and other infections caused by viruses, bacteria, or fungi. Call your doctor right away if you feel sick or get any of the following symptoms of infection, which may be early signs of a serious infection:
• a fever • feel very tired • have a cough • have flu-like symptoms • warm, red, or painful skin
• Allergic reactions. Allergic reactions can happen on the day of treatment or the day after receiving ORENCIA. Tell your doctor or get emergency medical help right away if you have hives, swollen face, eyelids, lips, tongue, throat, or trouble breathing.
Rx only
The information below does not take the place of talking with your healthcare professional. Only your healthcare professional knows the specifics of your condition and how ORENCIA®
may fit into your overall therapy. Talk to your healthcare professional if
• Cancer (malignancies). Certain kinds of cancer have been reported in patients receiving ORENCIA (abatacept). It is not known if ORENCIA increases your chance of getting certain kinds of cancer.
• Vaccinations. You should not receive ORENCIA with certain types of vaccines (live vaccines). ORENCIA may also cause some vaccinations to be less effective. Talk with your doctor about your vaccination plans.
• Respiratory problems in patients with Chronic Obstructive Pulmonary Disease (COPD). You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including:
• worsened COPD • pneumonia • cough • trouble breathing Common side effects of ORENCIA include:
• headache • upper respiratory tract infection • sore throat • nausea
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ORENCIA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
HOW WILL I RECEIVE ORENCIA?
• You will be given ORENCIA by a healthcare provider through a needle placed in a vein (IV or intravenous infusion) in your arm. It takes about 30 minutes to give you the full dose of medicine.
GENERAL INFORMATION ABOUT ORENCIA
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ORENCIA for a condition for which it was not prescribed.
You can ask your pharmacist or doctor for information about ORENCIA that is written for health professionals. For more information, go to
www.ORENCIA.com or the company internet site at
www.BMS.com or call 1-800-ORENCIA toll-free.
©2008 Bristol-Myers Squibb Company ORENCIA is a registered trademark of Bristol-Myers Squibb Company. Enbrel, Humira, Remicade, Kineret and Rituxan are trademarks of their respective companies.
Based on 1186240A4 04/08 B5-B0001C-04-08-RA
Printed in USA
427US08CBS00702 April/08
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