Orencia® (abatacept)
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Frequently asked questions


What is ORENCIA® (abatacept)?
ORENCIA is a prescription medicine that is used to treat adults with moderate to severe rheumatoid arthritis (RA), including those who have not been helped enough 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 doctor may consider treating you with ORENCIA because your disease is still active even though you may have tried other treatments.


What is the ORENCIA Promise Program?
The ORENCIA Promise Program is our copay program for new ORENCIA patients* with private insurance.

We will pay the full copay for ORENCIA for your first 6 months of therapy (8 infusions)
Plus, if you're not satisfied after 6 months we will pay your first copay of another RA medicine - up to $500

* Offer covers cost of medication copay only. Limited time offer. Promotion may not be offered in some states. Other restrictions and exclusions may apply.

Learn more about the ORENCIA Promise Program


What is juvenile idiopathic arthritis (JIA)?
JIA is arthritis of unknown cause that begins before 16 years of age and lasts for at least 6 weeks. JIA causes swelling with joint pain. It is also referred to as juvenile rheumatoid arthritis (JRA). The main symptoms children and teens with JIA may experience are:

Pain and swelling in the joints
Stiffness in the joints
Loss of function

How does ORENCIA work?
The immune system defends the body against infections caused by bacteria and viruses. A normal immune system leaves healthy body tissues alone. In people with RA, the immune system attacks normal body tissues causing damage and inflammation especially in the tissues of your joints.

ORENCIA is a rheumatoid arthritis medicine that keeps the immune system from attacking healthy tissues in the body to reduce pain and joint inflammation, and slow the damage to bones and cartilage. However, ORENCIA can also lower your body's ability to fight infection. Treatment with ORENCIA can make you more prone to getting infections or make any infection you have worse. It is important to tell your doctor if you think you have any infections.

What should I tell my doctor before treatment with ORENCIA?
Talk to your doctor if you have ever had an allergic reaction to ORENCIA or its ingredients to determine if you should receive ORENCIA.

Before you receive treatment with ORENCIA you should tell your doctor if you:

have any kind of infection even if it is small (such as an open cut or sore), or an infection that is in your whole body (such as the flu). If you have an infection when taking ORENCIA, you may have a higher chance for getting serious side effects.
have an infection that will not go away or a history of infections that keep coming back.
have had tuberculosis (TB), a positive skin test for TB, or 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 doesn’t go away, weight loss, fever, night sweats) call your doctor right away. Before you start ORENCIA, your doctor may examine you for TB or perform a skin test.
have or have had viral hepatitis. Before you use ORENCIA, your doctor may examine you for hepatitis.
have a history of chronic obstructive pulmonary (lung) disease (COPD).
are scheduled to have surgery.
are allergic to any of the ingredients in ORENCIA. See the end of this leaflet for a list of the ingredients in ORENCIA.

recently received a vaccination or are scheduled for any vaccination. If you are receiving ORENCIA, you should not take live vaccines.

have diabetes and use a blood glucose monitor to check your blood sugar (blood glucose) levels. ORENCIA contains maltose, a type of sugar that can give false high blood sugar readings with certain types of blood glucose monitors, on the day of ORENCIA infusion. Your doctor may tell you to use a different way to monitor your blood sugar levels.
are pregnant or planning to become pregnant. It is not known if ORENCIA can harm your unborn baby. Bristol-Myers Squibb Company has a registry for pregnant women exposed to ORENCIA. The purpose of this registry is to check the health of the pregnant mother and her child. Patients are encouraged to call the registry themselves or ask their doctors to contact the registry for them by calling 1-877-311-8972.
are breast-feeding. ORENCIA can pass into breast milk. Women who are breast-feeding should talk to their doctor about whether or not to use ORENCIA.
   

If you are not sure or have any questions about any of this information, ask your doctor.

What important information do I need to know about side effects with ORENCIA?
Orencia can cause serious side effects including:

Serious infections. Patients receiving ORENCIA have a higher chance of getting infections including pneumonia, and other infections caused by viruses, bacteria, or fungi. Call your doctor 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 on the day of treatment or the day after receiving ORENCIA. Tell your doctor or get emergency medical help right away if you have hives, swollen face, eyelids, lips, tongue, throat or trouble breathing.
Cancer (malignancies). Certain kinds of cancer have been reported in patients receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.
Vaccinations.You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.
Respiratory problems in patients with COPD. You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including: worsened COPD, pneumonia, cough, or trouble breathing.
   

What are the more common side effects with ORENCIA?
The more common side effects with ORENCIA in both adults and children are headache, upper respiratory tract infection, sore throat, and nausea. Other side effects in children may include diarrhea, cough, fever, and abdominal pain.

Can I receive ORENCIA if I am pregnant or breast-feeding?
ORENCIA has not been studied in pregnant women or nursing mothers, so we don't know what the effects are on pregnant women or nursing babies. You should tell your doctor if you are pregnant, become pregnant or are thinking about becoming pregnant.

Can I receive ORENCIA if I am taking other rheumatoid arthritis medicines for my RA or other conditions?
Yes, you can take other medicines if your doctor has prescribed them or has told you it is okay to take them while you are receiving ORENCIA. It is important to tell your doctor if you are taking any other medicines including hormones, over-the-counter medicines, vitamins, supplements, or herbal products before you are treated with ORENCIA. If you start taking or plan to start taking any new medicine while you are receiving ORENCIA, tell your doctor. ORENCIA should not be taken with biologic medications for RA such as Enbrel®, Humira®, Remicade®, or Kineret®.

How will ORENCIA be given to me?
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.

How often will I receive ORENCIA® (abatacept)?
You will receive your first dose of ORENCIA followed by a second dose at around day 15 and a third dose at around day 30. You will then continue therapy every four weeks thereafter. Please note that the actual day of dosing may vary based on patient scheduling.

What should I do if I miss a dose of ORENCIA?
If you miss receiving ORENCIA when you are supposed to, ask your doctor when to schedule your next dose.

What if I still have questions?
If you have any questions or problems, always talk with your doctor. You can also call 1-800-ORENCIA® toll-free or visit the company Internet site at www.BMS.com.

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ORENCIA® (abatacept) Important Safety Information

Indication and Usage
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. 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 can also 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. It is important to tell your doctor if you think you have any infections.

Important Safety Information About ORENCIA® (abatacept)

Before you receive treatment with ORENCIA, a lyophilized powder for intravenous infusion, you should tell your doctor about all your medical conditions, including if you:
have any kind of infection even if it is small (such as an open cut or sore) or an infection that is in your whole body (such as the flu).
have an infection that will not 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 get any of the symptoms of TB (a dry cough that doesn't go away, weight loss, fever, night sweats), call your doctor right away. Before you start ORENCIA, your doctor may examine you for TB or perform a skin test.
have or have had viral hepatitis. Before you use ORENCIA, your doctor may examine you for hepatitis.
have a history of chronic obstructive pulmonary (lung) disease (COPD).
are scheduled to have surgery.
are allergic to any of the following ingredients in ORENCIA: abatacept, maltose, monobasic sodium phosphate, or sodium chloride for administration.
recently received a vaccination or are scheduled for any vaccination. You should not take live vaccines if you are receiving ORENCIA.
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 doctor may tell you to use a different way to monitor your blood sugar levels.
are pregnant, planning to become pregnant, or are thinking about becoming pregnant. It is not known if ORENCIA can harm your unborn baby.
are breast-feeding. You will need to decide to either breast-feed or receive treatment with ORENCIA, but not both.
take any other kinds of medicine, including prescription and nonprescription medicines, vitamins, and herbal supplements.
are taking other biologic medicines to treat RA or JIA such as: Enbrel® (etanercept), Humira® (adalimumab), Remicade® (infliximab),
Kineret® (anakinra) or Rituxan® (rituximab). 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:
Serious infections. Patients receiving ORENCIA have a higher chance of getting infections including pneumonia, and other infections caused by viruses, bacteria, or fungi. Call your doctor 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 on the day of treatment or the day after receiving ORENCIA. Tell your doctor or get emergency medical help right away if you have hives, swollen face, eyelids, lips, tongue, throat or trouble breathing.
Cancer (malignancies). Certain kinds of cancer have been reported in patients receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.
Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.
Respiratory problems in patients with COPD. You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including: worsened COPD, pneumonia, cough, or trouble breathing.

The more common side effects with ORENCIA in both adults and children are headache, upper respiratory tract infection, sore throat, and nausea. Other side effects in children may include diarrhea, cough, fever, and abdominal pain.

Please read the Patient Information in the Full Prescribing Information.

Call 1-800-ORENCIA for more informationBristol-Myers Squibb
427US07WA38036 Nov/09