A prescription medicine reduces symptoms in adults with moderate to severe rheumatoid arthritis.

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Posted: Saturday, June 2, 2012 7:44 am

(NAPSI)ORENCIA (abatacept) is the first and only biologic for the treatment of adults with moderate to severe rheumatoid arthritis (RA) available in both self-injectable (under the skin) and intravenous (IV) infusion (through a vein in the arm) formulations. Since the majority of RA patients initiating therapy with a biologic receive their treatment by self-injection, the availability of the self-injectable formulation of ORENCIA offers physicians a choice for more of their patients.

ORENCIA (abatacept) is a prescription medicine that reduces signs and symptoms in adults with moderate to severe rheumatoid arthritis (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 adults, ORENCIA may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists.

ORENCIA can also make your immune system less able to fight infections, so you may be more likely to get infections or any infection you have may get worse. It is important to tell your healthcare provider if you think you have any infections.

Important Safety Information: Serious Infections

ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some patients have died from these infections. Call your healthcare provider immediately if you feel sick or get any of the following signs of infection: fever, feel very tired, cough, feel flu-like, or warm, red or painful skin.

I talked with my doctor about the self-injectable formulation of ORENCIA and we discussed that weekly ORENCIA self-injection might be a good choice for me, said Ray, a patient treated with ORENCIA IV. Patients should consult with their physician to see which treatment option is right for them.

Patients with RA can find that everyday tasks are much more difficult. Tasks like opening a car door, turning the handle on a faucet, buttoning a shirt or climbing stairs can become challenging.

Rheumatoid arthritis is a chronic, autoimmune disease characterized by inflammation in the lining of joints, causing joint damage with chronic pain, stiffness and swelling. RA causes limited range of motion and decreased joint function. The condition is more common in women, who account for 75 percent of patients diagnosed with RA.

ORENCIA is one treatment option indicated in adult patients with moderately to severely active RA and is intended for use under the guidance of a physician or healthcare practitioner. ORENCIA IV was approved for patients initiating therapy with a biologic in 2005. Since launch, more than 71,000 patients in the US have been prescribed ORENCIA IV.

For more information, talk to your doctor or visit www.ORENCIA.com and please read the Patient Information in the Full US Prescribing Information.

Please see the Important Safety Information that follows.

ORENCIA (abatacept) Important Safety Information:

Indication and Usage

ORENCIA (abatacept) is a prescription medicine that reduces signs and symptoms in adults with moderate to severe rheumatoid arthritis (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 adults, ORENCIA may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists.

ORENCIA can also make your immune system less able to fight infections, so you may be more likely to get infections or any infection you have may get worse. It is important to tell your health care provider if you think you have any infections.

Important Safety Information About ORENCIA) (abatacept)

Before you receive treatment with ORENCIA, a lyophilized powder for intravenous infusion or a solution for subcutaneous (under the skin) injection, you should tell your healthcare provider about all your medical conditions including if you:

have any kind of infection even if it is small (such as an open cut or sore) or an infection that is in your whole body (such as the flu).

have an infection that will not go away or a history of infections that keep coming back.

have had tuberculosis (TB), a positive skin test for TB, or if you recently have been in close contact with someone who has had TB. If you get any of the symptoms of TB (a dry cough that does not go away, weight loss, fever, night sweats), call your healthcare provider right away. Before you start ORENCIA, your health care provider may examine you for TB or perform a skin test.

have or have had viral hepatitis. Before you use ORENCIA, your health care provider 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 following ingredients in ORENCIA for infusion: abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration or the ingredients in ORENCIA injection: abatacept, sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injection.

recently received a vaccination or are scheduled for any vaccination. If you are receiving ORENCIA, and for 3 months after you stop receiving ORENCIA, you should not take live vaccines.

have diabetes and use a blood glucose monitor to check your sugar levels. The infusion of ORENCIA contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day you receive your infusion. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels. ORENCIA for subcutaneous injection (injected under the skin) does not contain maltose; therefore, you do not need to change the way you monitor your blood sugar if you are taking ORENCIA subcutaneously.

are pregnant, planning to become pregnant, or are thinking about becoming pregnant. It is not known if ORENCIA can harm your unborn baby.

are breast-feeding. You will need to decide to either breast-feed or receive treatment with ORENCIA, but not both.

take any other kinds of medicine, including prescription and nonprescription medicines, vitamins and herbal supplements.

are taking other biologic medicines to treat RA such as: Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), Kineret (anakinra), Rituxan (rituximab), Simponi (golimumab), Cimzia (certolizumab pegol),

Actemra (tocilizumab). You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines.

Possible Side Effects of ORENCIA (abatacept)

ORENCIA can cause serious side effects including:

Serious infections. ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some patients have died from these infections. Call your health care provider immediately if you feel sick or get any of the following signs of infection: fever, feel very tired, cough, feel flu-like, or warm, red or painful skin.

Allergic reactions. Allergic reactions can happen on the day of treatment or the day after receiving ORENCIA. Tell your healthcare provider or get emergency medical help right away if you have hives, swollen face, eyelids, lips, tongue or trouble breathing.

Hepatitis B infection. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ORENCIA. Your healthcare provider may do a blood test before you start or while using ORENCIA.

Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.

Respiratory problems in patients with COPD. You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including: worsened COPD, pneumonia, cough or trouble breathing.

Cancer (malignancies). Certain kinds of cancer have been reported in patients receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.

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

Please read the Patient Information in the Full US Prescribing Information.

2012 Bristol-Myers Squibb Company

ORENCIA is a registered trademark of Bristol-Myers Squibb. All other trademarks are property of their respective owners.

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