Indication/Usage and Important Safety Information for ORENCIA® (abatacept)
Adult Psoriatic Arthritis (PsA): ORENCIA® (abatacept) 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.
Important Safety Information
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 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® (abatacept) 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.
Possible Side Effects of ORENCIA
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 people 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.
• Allergic reactions. Allergic reactions can happen to people who use ORENCIA. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction, which may include 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 treatment with ORENCIA.
• Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.
• Respiratory problems in people with COPD. You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including: worsened COPD, cough, or trouble breathing.
• Cancer (malignancies). Certain kinds of cancer have been reported in people 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.
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.
Please read the Patient Information in the Full Prescribing Information.