For moderate to severe rheumatoid arthritis (RA)

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Indication/Usage

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).

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For Healthcare Professionals

 

Managing Your RA

GRETCHEN: Hi. My name is Gretchen. I'm from Missouri, and I'm an ORENCIA patient.

VO: 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. In adults, ORENCIA may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists. Please read Important Safety Information at the end of this presentation.

GRETCHEN: My message to give to someone hesitant to start on a biologic treatment would be that I was hesitant at first. I read all about them. I did my research, but it is scary to start a new treatment. One would be to…

GRETCHEN VO: Trust your doctor, to do your own research, ask your questions. And then see.

NANCY: Hi. I'm Nancy from New York, and I'm an ORENCIA patient.

NANCY: My treatment goals for my RA definitely were not being met to my standards. My rheumatologist had been telling me that I was being managed, but there was a day I walked into my classroom. I had difficulty carrying my bag out of my car, but then I got to my classroom door, put my key in the lock, and I absolutely could not turn it…

NANCY VO: …I grabbed my cell phone. I went into the hallway, and I called my office. I want to go on ORENCIA.

NANCY: And she agreed, and I felt that day I really spoke up for myself, and I think that's what I would encourage other patients to do.

AVO: Talk to your doctor and set reasonable expectations and treatment goals. It may take a little while for you to respond to the treatment. Some people see reduction in signs and symptoms sooner than others.

TONY: Hi, I'm Tony…

TONY VO: …from Idaho, and I'm an ORENCIA patient.

TONY: I met a woman who I started walking with at the park who has rheumatoid arthritis…

TONY: …and we started talking about different treatments…

TONY VO: She told me that she was very discouraged with the treatment.

TONY: The medicine wasn't doing her any good, so she decided to go on a natural food diet and tried to take care of herself that way, and I looked at her and I said you need to…

TONY VO: …educate yourself a little bit further, get your attitude changed…

TONY: …about treatments so that you can get on with your life.

AVO: Important Safety Information
Inform your healthcare provider of the following, before you receive treatment with ORENCIA®:
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, planning to become pregnant, or are thinking about becoming pregnant. It is not known if ORENCIA can harm your unborn baby.
Breastfeeding: You will need to decide to either breastfeed or receive treatment with ORENCIA, but not both.
If you Take Any Other Kinds of Medicine, including prescription and nonprescription medicines, vitamins, and herbal supplements.
If you are Taking Other Biologic Medicines to Treat RA 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 (abatacept)
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 patients 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, or 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 or while using ORENCIA.
• 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, cough, or trouble breathing.
Please read the Patient Information and Full Prescribing information found on ORENCIA.com

What is ORENCIA

SHANNON: Hi. I'm Shannon. I'm from Pennsylvania, and I'm an ORENCIA patient.

VO: 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. In adults, ORENCIA may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists. Please read Important Safety Information at the end of this presentation.

SHANNON: The moments that my doctor and I decided it was time to try ORENCIA was the time when…

SHANNON VO: …I could not get down on the floor to play with my baby. I wasn't able to really take care of him, play with him…and that was tough for me.

SHANNON: That's all I really wanted to do. So, when I went to my doctor and told him, I said I can't do this anymore. We need to try something else.

SHANNON VO: He agreed, and I'm very glad that I did.

SHANNON: Prior to my treatment with ORENCIA, my RA was managed with a couple of different medications.

SHANNON VO: Neither of them really worked for me.

SHANNON: Never got much better, but never got much worse, and…

SHANNON VO: …it just wasn't something that I was happy with.

SHANNON: The time that I realized that ORENCIA was working for me was the morning that I woke up, and I put my feet on the ground, and I didn't have the pain that I had once had. I was able to stand straight up and walk out of bed, which was a huge accomplishment for me.

AVO: Talk to your doctor and set reasonable expectations and treatment goals. It may take a little while for you to respond to the treatment. Some people see reduction in signs and symptoms sooner than others.

AVO: Important Safety Information
Inform your healthcare provider of the following, before you receive treatment with ORENCIA®:
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, planning to become pregnant, or are thinking about becoming pregnant. It is not known if ORENCIA can harm your unborn baby.
Breastfeeding: You will need to decide to either breastfeed or receive treatment with ORENCIA, but not both.
If you Take Any Other Kinds of Medicine, including prescription and nonprescription medicines, vitamins, and herbal supplements.
If you are Taking Other Biologic Medicines to Treat RA 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 (abatacept)
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 patients 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, or 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 or while using ORENCIA.
• 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, cough, or trouble breathing.
Please read the Patient Information and Full Prescribing information found on ORENCIA.com

Answers to your questions about ORENCIA® (abatacept)

GRETCHEN: Hi. My name is Gretchen. I'm from Missouri, and I'm an ORENCIA patient. I have utilized the support services offered by BMS…

GRETCHEN VO: …specifically the ORENCIA On Call program…

GRETCHEN: …mostly when I began with the self-injections. I know I had called for a little bit of support with that and how to actually administer the self-injections after I received information from my doctor, but then needed further information once I was home. I have also utilized it for information about sharps disposal.

GRETCHEN VO: I believe the benefits of the On Call program for ORENCIA are just having access to somebody.

GRETCHEN: If you're at home, and the doctor's office closes at 4:30 I think that it's great to have somebody that you can call. Both times I have called recently, I received quick concise responses. I wasn't on hold for a long time. So, I was able to…

GRETCHEN VO: …get what I needed and then just move on.

GRETCHEN: There was a time last year when I actually changed insurances three times, and so trying to navigate through that, calling the insurance company is not always a pleasant experience. So, I always had to find the right person to speak to, however…

GRETCHEN VO: …I was able to call 1-800-ORENCIA.

GRETCHEN: They did help me out along with the assistance from my doctor's office to make sure that I did not have a stoppage in treatment.

RA Video Library

  • Managing Your RA video thumb imageManaging Your RA
  • About ORENCIA video thumb imageAbout ORENCIA
  • Patient Support video thumb imagePatient Support Center
  • Rebecca's StoryRebecca's Story
  • Shannon's StoryShannon's Story
  • How ORENCIA worksHow ORENCIA works
  • Injection with IVInjection with IV
  • Injection with the Prefilled SyringeInjection with the Prefilled Syringe
  • Injection with the AutoinjectorInjection with the Autoinjector
 

Selected Important Safety Information

ORENCIA can cause serious side effects including:

Important Safety Information

Serious infections. ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some patients 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, or tongue; or trouble breathing.

Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.

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 or while using ORENCIA.

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.

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 to Treat RA or JIA 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, or 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® (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:

  • ORENCIA prefilled SC syringe is approved for patients 2 years and older
  • ORENCIA IV is approved for patients 6 years and older. ORENCIA IV has not been studied in children younger than 6 years of age.
  • ORENCIA ClickJect Autoinjector has not been studied in children under 18 years of age.

Please talk to your child’s healthcare provider about the best way for your child to receive ORENCIA.

Please click here to read the Patient Information in the Full Prescribing Information.

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