Adult Rheumatoid Arthritis (RA): 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 adults, ORENCIA may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists.
Juvenile Idiopathic Arthritis (JIA): ORENCIA reduces signs and symptoms in patients 2 years of age and older with moderate to severe polyarticular JIA. ORENCIA may be used alone or with methotrexate (MTX).
Adult Psoriatic Arthritis (PsA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults with active Psoriatic Arthritis (PsA). In adults, ORENCIA may be used alone or with other PsA treatments.
Inform your healthcare provider of the following, before you receive treatment with ORENCIA® (abatacept):
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 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: 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® (abatacept) 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, or plan to become pregnant. It is not known if ORENCIA can harm your unborn baby. If you took ORENCIA during pregnancy, talk to your healthcare provider before your baby receives any vaccines.
Breastfeeding: It is not known if ORENCIA passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you use ORENCIA.
If you Take Any Other Kinds of Medicine, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
If you are Taking Other Biologic Medicines such as: Enbrel® (etanercept), Humira® (adalimumab), Remicade® (infliximab), Kineret® (anakinra), Rituxan® (rituximab), Simponi® (golimumab), Cimzia® (certolizumab pegol), or Actemra® (tocilizumab). You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines.
ORENCIA can cause serious side effects including:
Common side effects with ORENCIA® (abatacept) 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.
These are not all the possible side effects of ORENCIA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
There are three ways to receive your dose of ORENCIA, and each way is approved for different ages:
Please talk to your healthcare provider about the best way to receive ORENCIA.
Please click here to read the Patient Information in the Full Prescribing Information.