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Brand Names: Orencia

Generic Name: abatacept (Pronunciation: a BAY ta sept)

• What is abatacept (Orencia)?
• What are the possible side effects of abatacept (Orencia)?
• What is the most important information I should know about abatacept (Orencia)?
• What should I discuss with my healthcare provider before using abatacept (Orencia)?
• How should I use abatacept (Orencia)?
• What happens if I miss a dose (Orencia)?
• What happens if I overdose (Orencia)?
• What should I avoid while using abatacept (Orencia)?
• What other drugs will affect abatacept (Orencia)?
• Where can I get more information?

What is abatacept (Orencia)?

Abatacept is a man-made protein that prevents your body's immune system from attacking healthy tissues such as joints. The immune system helps your body fight infections. In people with autoimmune disorders, the immune system mistakes the body's own cells for invaders and attacks them.

Abatacept is used to treat the symptoms of rheumatoid arthritis, and to prevent joint damage caused by these conditions. It is also used to treat arthritis in children who are at least 6 years old.

Abatacept is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.

Abatacept may also be used for other purposes not listed in this medication guide.

What are the possible side effects of abatacept (Orencia)?

Some people receiving an abatacept injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, itchy, or have a severe headache or trouble breathing within 1 hour after receiving the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with abatacept. Stop using abatacept and call your doctor right away if you have signs of infection such as:

• fever, sweating, chills, tired feeling;
• feeling short of breath;
• dry cough, sore throat; or
• flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:

• trouble breathing;
• easy bruising or bleeding, pale skin, unusual weakness;
• pain or burning when you urinate; or
• signs of skin infection such as itching, swelling, warmth, redness, or oozing.

Less serious side effects may include:

• headache, dizziness;
• cold symptoms such as stuffy nose, sneezing, sore throat, cough;
• nausea, diarrhea, stomach pain, indigestion; or
• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about abatacept (Orencia)?

You should not use this medication if you are allergic to abatacept, or if you are also using anakinra (Kineret), etanercept (Enbrel), adalimumab (Humira), or infliximab (Remicade).

Before using abatacept, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Also tell your doctor if you have a weak immune system, any type of infection (including skin infection or open sores), COPD, diabetes, a history of hepatitis, or if you have scheduled to receive any vaccinations.

Children using this medication should be current on all childhood immunizations before starting treatment with abatacept.

Serious infections may occur during treatment with abatacept. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or if you feel short of breath.

Using abatacept may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes). This risk may be greater in older adults. Talk to your doctor about your specific risk.