About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a systemic, chronic, autoimmune disease characterized by inflammation in the lining of joints (or synovium), causing joint damage with chronic pain, stiffness, swelling and fatigue. RA causes limited range of motion and decreased joint function. The condition is more common in women than in men, who account for 75% of patients diagnosed with RA.
About ORENCIA® (abatacept)
ORENCIA SC and IV is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. ORENCIA may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.
ORENCIA IV is indicated for reducing signs and symptoms in pediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. ORENCIA IV may be used as monotherapy or concomitantly with methotrexate (MTX). ORENCIA SC has not been studied in pediatric patients.
ORENCIA should not be administered concomitantly with TNF antagonists.
ORENCIA is not recommended for use concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.
ORENCIA is intended for use under the guidance of a physician or healthcare practitioner.
Indication/Usage and Important Safety Information for ORENCIA® (abatacept)
Adult Rheumatoid Arthritis (RA): 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.
Juvenile Idiopathic Arthritis (JIA): ORENCIA also reduces signs and symptoms in children and adolescents 6 years of age and older with moderate to severe polyarticular juvenile idiopathic arthritis (JIA). ORENCIA may be used alone or with methotrexate (MTX).
Important Safety Information About ORENCIA® (abatacept)
Inform your healthcare provider of the following, before you receive treatment with ORENCIA:
Infections: If you have any kind of infection, even if it is small (such as an open cut or sore), an infection that is in your whole body (such as the flu), an infection that will not go away, or a history of infections that keep coming back. ORENCIA may 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.
Tuberculosis: If you 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 healthcare provider may examine you for TB or perform a skin test.
If you have or have had Viral Hepatitis. Before you use ORENCIA, your healthcare provider may examine you for hepatitis.
If you have a history of Chronic Obstructive Pulmonary (lung) Disease (COPD).
If you are scheduled to have Surgery.
Allergies to the Ingredients of ORENCIA®(abatacept): The ingredients of intravenous (IV) ORENCIA are: abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration. The ingredients of subcutaneous (SC) ORENCIA are: abatacept, sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injection.
Vaccinations: If you have 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.
Diabetes: If you 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 SC injection does not contain maltose; therefore, you do not need to change the way you monitor your blood sugar if you are taking ORENCIA subcutaneously.
Pregnancy: If you are pregnant, planning to become pregnant, or are thinking about becoming pregnant. It is not known if ORENCIA can harm your unborn baby.
Breastfeeding: You will need to decide to either breast-feed or receive treatment with ORENCIA, but not both.
If you Take Any Other Kinds of Medicine, including prescription and nonprescription medicines, vitamins, and herbal supplements.
If you 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:
Common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea. Other side effects in children and adolescents may include diarrhea, cough, fever, and abdominal pain.
Note concerning use in children under 18 years of age: ORENCIA for SC injection has not been studied in children under 18 years of age, therefore it is not known if ORENCIA for SC injection is safe and effective in children under 18 years of age.
Clazakizumab is an investigational selective IL-6 cytokine inhibitor, under investigation for the treatment of RA. Bristol-Myers Squibb has exclusive worldwide rights to develop and commercialize clazakizumab for all indications outside of cancer under a collaboration agreement with its discoverer, Alder Biopharmaceuticals. Clazakizumab is the second biologic treatment for RA being developed by Bristol-Myers Squibb, demonstrating the company's long-standing commitment to immunoscience.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
ORENCIA® (abatacept) is a registered trademark of Bristol-Myers Squibb Company.
About Bristol-Myers Squibb Immunoscience
The immune system is the body's natural defense against disease. These processes come into play in almost every human disease. That is why Bristol-Myers Squibb is focused on exploring ways to harness the body's own immune system to treat immune-related diseases with high unmet medical needs, including RA - a chronic, systemic, inflammatory autoimmune disorder that affects the joints.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.