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SELECTED IMPORTANT SAFETY INFORMATION

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.

More Important Safety Information

Important Safety Information and Indication/Usage

Important Safety Information

More 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 dry 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 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 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® (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, pneumonia, cough, 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.

Common side effects with ORENCIA 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.

Note concerning ORENCIA SC: ORENCIA for SC injection has not been studied in children under 18 years of age, therefore it is not known if ORENCIA for SC injection is safe and effective in children under 18 years of age.

Indication/Usage

Adult Rheumatoid Arthritis (RA): 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.

Juvenile Idiopathic Arthritis (JIA): 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 may be used alone or with methotrexate (MTX).

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

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TERMS AND CONDITIONS FOR THE ORENCIA® (abatacept) COPAY PROGRAM FOR IV INFUSION

Eligibility, Terms, and Conditions

  • The Copay card is not an insurance card. This program assists patients with their out-of-pocket drug cost of ORENCIA only, not the cost of the infusion.
  • Eligible patients must be appropriate patients for the treatment of moderate to severely active RA or moderate to severely active polyarticular JIA with ORENCIA.
  • Eligible patients must have commercial insurance that pays for ORENCIA. Savings are not applicable to out-of-pocket expenses of $5 or less.
  • Your acceptance of this offer confirms that this offer is consistent with your insurance and that you will report the value received as may be required by your insurance provider.
  • Patients enrolled in Medicare, Medicare Part D, Medicare Advantage, Medicaid, Tricare, Veterans Affairs (VA), Department of Defense (DoD), other state- or federally-funded programs, or where otherwise prohibited by law are not eligible for this program.
  • Patients who move from commercial to federally-funded insurance will no longer be eligible for the program.
  • Federally-funded commercial insurance plans are NOT eligible.
  • All coverage requirements mandated by the insurance company of the eligible patient must be satisfied in order for the program to take effect.
  • Proof required for reimbursement must be a valid Explanation of Benefits (EOB) with ORENCIA J Code specific information.
  • EOB must be submitted regardless of assigned J Code value.
  • EOB must be submitted within 90 days post-infusion to receive benefit.
  • First ORENCIA infusion must take place within 60 days of enrollment in the program.
  • Enrollment Period is 12 months from date of enrollment.
  • Program has a payment cap of $8,000 for the 12-month term of enrollment.
  • Benefits may apply to one retroactive infusion that occurred within 45 days prior to the date of enrollment, only for patients who have had their eligibility confirmed by the program.
  • Active copay cards are for use at the patient’s participating healthcare provider office where MasterCard® debit cards are accepted.
  • Healthcare providers who do not accept electronic transactions will be identified on enrollment form and program benefits will be issued to the participating patient by check.
  • When the prescription for ORENCIA is filled directly by a pharmacy, the program card serves as payment mechanism at the pharmacy only.
  • For Hospital Outpatient Departments or Alternate Sites of Care, each facility serves as an infusion site-of-care only. Patient is responsible for site of care financial obligation and will receive program benefits by check.
  • This offer is valid in the United States, excluding where it is prohibited by law.
  • BMS reserves the right to modify or terminate this offer, or the program in its entirety, at any time.
  • This is a limited time offer. Other restrictions and exclusions may apply; please refer to THE ORENCIA® (abatacept) COPAY PROGRAM brochure for infusion for more information.
 

TERMS AND CONDITIONS FOR THE ORENCIA® (abatacept) COPAY PROGRAM FOR SUBCUTANEOUS

Eligibility, Terms, and Conditions

  • Eligible patients must be appropriate adult patients (18 years of age or older) for the treatment of moderate to severely active RA.
  • Eligible patients must have commercial insurance that pays for ORENCIA. Savings are not applicable to out-of-pocket expenses of $5 or less.
  • Your acceptance of this offer confirms that this offer is consistent with your insurance and that you will report the value received as may be required by your insurance provider.
  • Patients enrolled in Medicare, Medicare Part D, Medicare Advantage, Medicaid, Tricare, Veterans Affairs (VA), Department of Defense (DoD), other state- or federally-funded programs, or where otherwise prohibited by law are not eligible for this program.
  • Patients who move from commercial to federally-funded insurance will no longer be eligible for the program.
  • Federally-funded commercial insurance plans are NOT eligible.
  • The ORENCIA Copay Assistance Card is not insurance. The card must be presented at the pharmacy along with a valid prescription for ORENCIA for self-injection, at the time of purchase.
  • Patient pays $5 out-of-pocket drug cost per one month supply with no monthly benefit limit.
  • Copay Assistance Card benefit includes 12 uses per calendar year, up to a maximum benefit of $8,000.
  • This offer is valid in the United States, excluding where it is prohibited by law.
  • BMS reserves the right to modify or terminate this offer, or the program in its entirety, at any time.
  • Other restrictions and exclusions may apply; please refer to THE ORENCIA COPAY PROGRAM brochure for self-injection for Terms and Conditions.

REIMBURSEMENT OPTION

If your pharmacy does not accept your ORENCIA® (abatacept) Copay Assistance Card, you can still receive the same benefits using the provided rebate form.

  • Complete the reimbursement form provided in your Copay Assistance Card package.
  • Enclose the original pharmacy receipt. (A valid receipt should include your name, the name of the medicine you purchased, the date, and the amount you paid.)    Be sure to circle:
  • ORENCIA® (abatacept)
  • date of purchase
  • amount you paid
  • medication quantity
  • Include a photocopy of your Copay Assistance Card.
  • Enclose the original receipt and photocopy of your Copay Assistance Card in the pre-paid reimbursement form, seal all 3 sides and place in the mail.

ORENCIA® (abatacept) FOR INITIAL IV INFUSION

REIMBURSEMENT OPTION

Eligible patients can also get help with their out-of-pocket drug costs for the initial intravenous dose of ORENCIA for infusion.

  • The purpose of this program is to assist patients with out-of-pocket drug cost for the initial infusion of ORENCIA, if prescribed by the doctor. Only the drug cost of the ORENCIA copay is eligible for reimbursement, NOT the cost of the infusion.
  • Eligible patients must be appropriate adult patients for the treatment of moderate to severely active rheumatoid arthritis.
  • Eligible patients must have commercial insurance that pays for ORENCIA. Savings are not applicable to out-of-pocket expenses of $5 or less.
  • Your acceptance of this offer confirms that this offer is consistent with your insurance and that you will report the value received as may be required by your insurance provider.
  • Patients enrolled in Medicare, Medicare Part D, Medicare Advantage, Medicaid, Tricare, Veterans Affairs (VA), Department of Defense (DoD), other state- or federally-funded programs, or where otherwise prohibited by law are not eligible for this program.
  • Federally-funded commercial insurance plans are NOT eligible.
  • Patients who move from commercial to federally-funded insurance will no longer be eligible for the program.
  • Program benefit is limited to a single date of service.
  • All coverage requirements mandated by the insurance company of the eligible patient must be satisfied in order for the program to take effect.
  • Proof required for reimbursement must be a valid Explanation of Benefits (EOB) with ORENCIA J Code specific information.
  • EOB must be submitted regardless of assigned J Code value.
  • EOB must be submitted within 90 days post-infusion to receive benefit.
  • This offer is valid in the United States, excluding where it is prohibited by law.
  • BMS reserves the right to modify or terminate this offer, or the program in its entirety, at any time.
  • Other restrictions and exclusions may apply; please refer to THE ORENCIA® (abatacept) COPAY PROGRAM brochure for self-injection for Terms and Conditions.
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ORENCIA(R) (abatacept)

Indication

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For more information call 1-800-ORENCIA or

 

Indication

ADULT RHEUMATOID ARTHRITIS (RA)

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.

 

Juvenile Idiopathic Arthritis (JIA)

ORENCIA® (abatacept) reduces signs and symptoms in children and adolescents 6 years of age and older with moderate to severe polyarticular juvenile idiopathic arthritis (JIA). ORENCIA may be used alone or with methotrexate (MTX).

 
 

On ORENCIA® (abatacept)

You and your doctor have made a choice to treat your moderate to severe RA with ORENCIA.

Knowing what to expect with treatment, what options you have for receiving ORENCIA, and where to get answers to your questions is important.

Setting expectations

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

Moderate to severe rheumatoid arthritis (RA) affects each person differently. Just as your RA symptoms may differ from someone else's, results from treatment may also vary. Unfortunately, there is no way to know ahead of time how you will respond to any RA treatment.

View the clinical results below to see how ORENCIA® (abatacept) has helped other patients.

SELECTED IMPORTANT SAFETY INFORMATION

ORENCIA® (abatacept) 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.

 

What ORENCIA® (abatacept) could do to help

ORENCIA is a biologic used for the treatment of moderate to severe RA in adults; it helps to stop further joint damage and calm the swelling associated with RA.

ORENCIA® (abatacept) was studied in several clinical trials on patients for whom either methotrexate or a TNF blocking agent did not work well enough. ORENCIA showed reduction in the signs and symptoms of moderate to severe RA and helped improve ability to perform daily activities.

Of course, every patient is different. How you respond to treatment may vary from how other patients respond.

SELECTED IMPORTANT SAFETY INFORMATION

Common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea.

Study overviews

Study III: ORENCIA intravenous infusion (IV) was tested in adults with moderate to severe RA who did not respond well enough to MTX. Patients were given ORENCIA IV plus MTX (424 patients) or MTX alone (214 patients). At 6 months, patients' signs and symptoms were measured, and at 1 year, their physical function and joint damage were assessed.

Study IV: ORENCIA IV was tested in adults with moderate to severe RA who did not respond well enough to a TNF blocker (eg, Enbrel® (etanercept), Humira® (adalimumab), and Remicade® (infliximab). Patients were given ORENCIA IV plus a nonbiologic DMARD (256 patients) or a nonbiologic DMARD alone (133 patients). Their signs and symptoms and their physical function were measured at 6 months.

Study SC-I: ORENCIA self-injection (subcutaneous; SC) and ORENCIA IV were evaluated in 1457 patients with moderate to severe RA who did not respond well enough to MTX. Patients were given ORENCIA SC plus MTX or ORENCIA IV plus MTX and evaluated at 6 months.

DMARD=disease-modifying antirheumatic drug. MTX=methotrexate TNF=Tumor necrosis factor

 

ORENCIA® (abatacept) intravenous (IV) was tested in 638 adults with moderate to severe RA who had not responded well enough to MTX. Patients were given ORENCIA IV plus MTX (424 patients) or MTX alone (214 patients). At 6 months, patients' signs and symptoms were measured, and at 1 year, their physical function and joint damage were assessed.

ORENCIA intravenous (IV) was tested in 389 adults with moderate to severe RA who had not responded well enough to a TNF blocker (eg, Enbrel® (etanercept), Humira® (adalimumab), and Remicade® (infliximab)). Patients were given either ORENCIA IV plus a nonbiologic DMARD (256 patients) or a nonbiologic DMARD alone (133 patients). Their signs and symptoms and their physical function were measured at 6 months.

At 6 months in Trial 3, improvement in signs, symptoms, and reported side effects were comparable for ORENCIA SC and ORENCIA IV.

ORENCIA subcutaneous (SC), also called self-injection, and ORENCIA IV were evaluated in 1,457 patients with moderate to severe RA who had not responded well enough to MTX. Patients were given ORENCIA SC plus MTX or ORENCIA IV plus MTX and evaluated signs and symptoms and physical function at 6 months.

DMARD=disease-modifying antirheumatic drug.

 

ORENCIA® (abatacept) IV was tested in adults with moderate to severe RA who had not responded well enough to MTX. Patients were given ORENCIA IV plus MTX (424 patients) or MTX alone (214 patients). At 6 months, patients' signs and symptoms were measured, and at 1 year their physical function and joint damage were assessed.

ORENCIA IV was tested in adults with moderate to severe RA who had not responded well enough to a TNF blocker Embrel® (etanercept), Humira® (adalimumab), and Remicade® (infliximab). Patients were given either ORENCIA IV plus a nonbiologic DMARD (256 patients) or a nonbiologic DMARD alone (133 patients). Their signs and symptoms and their physical function were measured at 6 months.

Live Chat or call 1-800-ORENCIA, we're here for you 24/7*

ORENCIA On-Call(TM) Logo

When you are on ORENCIA® (abatacept), you have support. We know how important it is to have another person on your team, someone to talk to, to help you, to be there every step of the way. Get financial support to help with out-of-pocket costs and many other free support services.

Look to ORENCIA On Call™ for help with things like:

24/7 Assistance

Travel Cold Case

Welcome Package

Product Replacements

Sharps Disposal

Tools and Tips for Living with RA

  • or
  • ORENCIA On-Call(TM) Phone Number

*Live Chat is available 9 am to midnight ET. ORENCIA Care Counselors are available 24/7 at 1-800-ORENCIA.

*The ORENCIA Care Counselor cannot provide medical advice. Your doctor is the best source of information about your health.

If you think you've received a damaged syringe or if the solution appears cloudy, discolored or contains large particles, a replacement will be provided.

ORENCIA® (abatacept) copay assistance

ORENCIA Co-pay Program(TM) Cards
ORENCIA Co-pay Program(TM) Request More Info

ORENCIA copay assistance is a financial program to help eligible patients with out-of-pocket drug costs. The ORENCIA Copay Program is part of ORENCIA On Call, so you only need to sign up once.

Services for ORENCIA® (abatacept) SC

If you and your doctor have decided that ORENCIA for subcutaneous (SC) use is right for you, take advantage of these additional free services, designed to help you with your in-home treatment with ORENCIA.

ORENCIA(R) (abatacept) Welcome Pack

Welcome Pack

If you have been prescribed ORENCIA SC, you probably already have your ORENCIA Welcome Pack. If not, for ORENCIA On Call to get one now.*

The ORENCIA Welcome Pack comes with helpful tools and information to get you started on ORENCIA SC. Inside you'll find step-by-step injection instructions, insurance information, information about how to connect with an ORENCIA Care Counselor, and much more.

*Limit 1 Welcome Pack per patient. Restrictions and exclusions apply.

Travel Pack

Using ORENCIA SC means you can bring ORENCIA with you on the go with the ORENCIA Travel Pack.* Ergonomically designed and easy to open, the pack includes:

  • Secure compartments for your ORENCIA syringes
  • Reusable cold pack
  • Self-injection instructions
  • Emergency contacts card

.

*Limit 1 Travel Pack per patient. Restrictions and exclusions apply.

ORENCIA(R) (abatacept) Travel Pack
Sharps Disposal Container

Free sharps disposal

It's important to properly dispose of your used ORENCIA syringes, which is why we offer convenient, free sharps disposal service.

Here's how it works:

  1. , and we'll send you a sharps container by mail
  2. Follow the enclosed instructions to fill the sharps container with your used ORENCIA syringes
  3. Mail your filled sharps container using the prepaid postage package. As soon as we receive it, we'll send you a new container

*Limit of 2 sharps containers provided per year. Restrictions and exclusions apply.

IMPORTANT: Always keep your sharps containers out of reach of children and animals. Never empty the contents of your sharps container in order to reuse it. If you don't have another sharps container, you may dispose of your used syringe in a hard plastic container with a screw-on cap (such as an empty detergent bottle) or in a metal container with a plastic lid (such as a coffee can). When the container is full, tape around the cap or lid to make sure the cap or lid does not come off. Ask your doctor, nurse, or pharmacist about state and local laws regarding the proper disposal of medical products that contain needles.

Drug replacement

If you think you received a damaged syringe, or if the solution is cloudy, discolored, or has lumps or particles, call your ORENCIA Care Counselor at 1-800-ORENCIA. Do not use an ORENCIA syringe if you think it may be unsafe. Instead:

  • Call 1-800-ORENCIA
  • We will confirm your active prescription for ORENCIA with your doctor before shipping your medicine

Due to international shipping limitations, drug replacement is limited to shipments in the continental United States. Additional restrictions and exclusions apply.

ORENCIA Care Counselor
  • or
  • ORENCIA On-Call(TM) Phone Number

SELECTED IMPORTANT SAFETY INFORMATION

ORENCIA® (abatacept) can cause serious side effects including:

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.

ORENCIA® (abatacept) works in a different way than other RA treatments.

It's thought that inflammation in rheumatoid arthritis (RA) can be triggered when T cells in the immune system become activated. ORENCIA works at a source early in the inflammation process. This can help reduce the activity of T cells.

 
 

SELECTED IMPORTANT SAFETY INFORMATION

ORENCIA® (abatacept) can cause serious side effects including:

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

How to take ORENCIA® (abatacept)

If you are about to start ORENCIA or you already have, it is important to know your dosing options. ORENCIA can be given as a monthly intravenous (IV) infusion or weekly subcutaneous (SC) injection. You and your doctor will decide which option is best for you.

IV Infusion Video

IV infusion

An IV (through a vein) infusion of ORENCIA is given in your arm by a healthcare professional. This once-a-month procedure at the doctor's office usually takes about 30 minutes.

Watch the video to become more familiar with what to expect when receiving your infusion of ORENCIA.

SC Injection Video

SC injection

ORENCIA can be given as an injection under your skin—and you can administer it yourself. After you receive training at your doctor's office, this once-weekly injection can be done in the convenience of your home.

Download ORENCIA Self-Injection Guide (PDF)

SELECTED IMPORTANT SAFETY INFORMATION

ORENCIA® (abatacept) can cause serious side effects including:

Allergic reaction. 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.