This is a summary of the most important iformation about Orencia. For details, talk to your healthcare professional.

What Is Orencia?

Orencia is a medicine that is used to treat adults with moderate to severe rheumatoid arthritis (RA) who have not been helped by other medicines for RA. RA is a disease that causes pain and joint inflammation (tenderness and swelling). RA can also cause joint damage. Your healthcare professional has decided to treat you with Orencia because your disease is still active even though you may have tried other treatments.

Who Should Not Be Treated With Orencia?

You should not receive Orencia if you have ever had an allergic reaction to Orencia.

What Are The Risks?

The following are the major potential risks and side effects of Orencia therapy. However, this list is not complete.

The following are the major possible risks and side effects of Orencia therapy:

• Serious infections.
  • Patients taking Orencia are at increased risk for developing infections including pneumonia, and other infections caused by viruses, bacteria, or fungi. Call your healthcare professional immediately if you feel sick or get any infection during treatment with Orencia.
• Allergic reactions.
  • These reactions are usually mild or moderate and include hives, swollen face, eyelids, lips, tongue, throat, or trouble breathing.
• Malignancies.
  • There have been rare cases of certain kinds of cancer in patients receiving Orencia. The role of Orencia in the development of cancer is not known.
• Some common side effects that may occur with Orencia include:
  • headache
  • upper respiratory tract infection
  • sore throat
  • nausea

What Should I Tell My Healthcare Professional?

Before you start taking Orencia, tell your healthcare professional if you:

• are taking a TNF blocker to treat RA. You may have a higher chance of getting a serious infection if you take Orencia with other biologic medications for RA.
• have any kind of infection including an infection that is in only one place in your body (such as an open cut or sore), or an infection that is in your whole body (such as the flu). Having an infection could put you at risk for serious side effects from Orencia. If you are unsure, please ask your healthcare professional.
• have an infection that won’t 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 develop any of the symptoms of TB (a dry cough that doesn’t go away, weight loss, fever, night sweats) call your healthcare professional right away. Before you start Orencia, your healthcare professional may examine you for TB or perform a skin test.
• are scheduled to have surgery.
• recently received a vaccination or are scheduled for any vaccination.
• are trying to become pregnant or are already pregnant. It is not known if Orencia can harm your unborn baby.
• are breastfeeding. Orencia can pass into breast milk. You will need to decide to either breastfeed or receive treatment with Orencia, but not both.

Can Other Medicines Or Food Affect Orencia?

Orencia and certain other medicines may interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.  Know the medicines you take. Keep a list of them with you to show your healthcare professional.

Taking Orencia with TNF blocker medications (Enbrel, Humira, Remicade) is not recommended.

How Should I Receive Orencia?

• Orencia will be given to you by a healthcare professional using an IV. This means the medicine will be given to you through a needle placed in a vein in your arm. It will take about 30 minutes to give you the full dose of medicine.
• You will receive your first dose of Orencia followed by additional doses at 2 and 4 weeks after the first dose. You will then receive a dose every 4 weeks.

Date Approved: 12/23/05

Date Reviewed

Date Updated: 02/15/2006