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.

ORENCIA reduces signs and symptoms in children and adolescents 6 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

Frequently Asked Questions

Frequently asked questions
for patients with rheumatoid arthritis

You have questions, we have answers. Pick a subject below to find answers to
frequently asked questions about ORENCIA® (abatacept) and moderate to
severe rheumatoid arthritis (RA).

ORENCIA insurance questions
Will my insurance cover ORENCIA?
Many insurance plans cover ORENCIA. To get help finding out if you
are covered by your insurance, visit the Patient Support Center. To help find out if your insurance covers ORENCIA, you can call 1-800-ORENCIA and speak to an insurance specialist who can help verify your coverage.
What if my insurance does not cover ORENCIA?
For patients with insurance that does not cover ORENCIA, BMS Access Support® provides resources that help patients with their reimbursement challenges. BMS Access Support can also assist you in finding information on financial support. Visit the Financial Support Assistance page for more information.
How to take ORENCIA prefilled syringe or ORENCIA ClickJect Autoinjector
How much ORENCIA do I need to take, and how often do I need to take it?
If you are prescribed ORENCIA self-injection, you should follow your doctor's instructions. The recommended dosage for this under-the-skin injection of 125 mg once-weekly. Visit the How to Take ORENCIA section and talk to your doctor for more information.
I missed a dose; what should I do?
If you miss a scheduled dose of ORENCIA, talk to your doctor to find out when you should take your next dose. Try your best to take ORENCIA
as scheduled, and set reminders on days that you are scheduled to
take ORENCIA.
Injecting ORENCIA (prefilled syringe or Autoinjector)
How do I inject ORENCIA?
Your doctor should show you how to properly inject ORENCIA before you try it yourself. If you have been trained at your doctor's office, watch a refresher video here.
Where do I inject ORENCIA?
If you are self-injecting, it is recommended that you use the front of your thigh or your abdomen except for the 2-inch area around your navel.

If the injection is being given by a caregiver, the outer area of the upper arms may also be used. Do not attempt to use the upper arm area by yourself, and be sure to choose a different injection site for each new injection. For a refresher on injection steps, visit How to Take ORENCIA.
Can I inject ORENCIA without letting it warm up?
No. After removing ORENCIA from the refrigerator, let it warm up for 30 to 60 minutes to allow it to reach room temperature. Do not attempt to speed up the warming process in any way.
I feel a little bit of burning or pain during injection. Is this normal?
When giving yourself an injection, you may feel a prick from the needle. Sometimes, the medicine can cause slight irritation near the injection site. This may happen and the discomfort should be mild to moderate. If you have any side effects, including pain, swelling, or discoloration near the injection site, contact your health care provider.
Disposal after injecting ORENCIA (prefilled syringe or Autoinjector)
What should I do with my syringe or Autoinjector after injecting ORENCIA?
It is important to properly dispose of syringes in a sharps container. ORENCIA On Call offers a sharps disposal service. Find out more at the Patient Support Center.

Do not throw away used syringes in the household trash and do not
recycle them.

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, place adhesive 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.
What should I do when my sharps container is full?
If you are signed up for On Call, you can mail back your filled sharps container using the prepaid postage package. As soon as we
receive it, we'll send you a new container. Find out more at the
Patient Support Center.
Storing ORENCIA (prefilled syringe or Autoinjector)
How should I store my ORENCIA prefilled syringe or Autoinjector?
Store ORENCIA in the refrigerator at 36°F to 46°F (2°C to 8°C) until you are ready to use. Be sure to keep ORENCIA in the original package and out of the light. DO NOT freeze ORENCIA.

Safely throw away medicine that is out of date or no longer needed.
What if my prefilled syringe or Autoinjector does not stay cool for an extended period of time? Is it dangerous to use?
Contact 1-800-ORENCIA (1-800-673-6242) for details.
Traveling with ORENCIA prefilled syringe or Autoinjector
How should I keep my prefilled syringes or Autoinjector cool while traveling?
If you need to take your prefilled syringes or Autoinjector with you, store them in a cool carrier between 36°F to 46°F (2°C to 8°C) until you are ready to use.

DO NOT freeze ORENCIA.

Keep ORENCIA in the original carton and protected from light. Your health care provider may know about special carrying cases for injectable medicines.
Can I take my prefilled syringes or Autoinjector on an airplane?
Generally, you are allowed to carry ORENCIA prefilled syringes or Autoinjector with you on an airplane. Be sure to carry the prefilled syringes or Autoinjector with you on board the plane, and do not put them in your "checked" luggage. You should carry ORENCIA prefilled syringes or Autoinjector with you in your travel cooler at a temperature of 36°F to 46°F (2°C to 8°C) until you are ready to use.

Keep ORENCIA in the original carton, with its original preprinted labels, and protected from light.
What if my prefilled syringe or Autoinjector does not stay cool for an extended period of time? Is it dangerous to use?
Contact 1-800-ORENCIA (1-800-673-6242) for details.
Rheumatoid arthritis facts
What is moderate to severe RA?
Rheumatoid arthritis (RA) is an autoimmune disease that causes inflammation in your joints. This inflammation can cause pain, swelling, stiffness, and reduced mobility. RA is a chronic illness, which means it doesn't go away. Over time, it may lead to permanent joint damage and physical disability. Appropriate diagnosis and treatment are important to best manage your RA. Find out more in Understanding RA.
What causes RA?
RA is an autoimmune disease, meaning your immune system becomes overactive and mistakenly attacks the healthy tissues in your own body. In RA, a key target of the overactive immune system is the lining of the joints, also known as the synovium.

The exact cause of RA is unknown. RA may be influenced by many risk factors, including genes, infection, hormonal changes, or environmental factors. Find out more in Understanding RA.
What are the symptoms of RA?
RA affects the joints in your body, so it can have many symptoms, including joint pain and reduced mobility. Find out more in Understanding RA.
Rheumatoid arthritis terminology
  • Biologic: Biologics are a type of RA therapy that are made from a living organism.
  • Clinical trials: Clinical trials are research studies that assess the effectiveness of treatments.
  • Inflammation: Inflammation is a response to injury or infection that causes redness, heat, swelling, pain, and a loss of physical function.
  • Rheumatoid factor: An antibody that appears in the blood of the majority of
    RA patients.
  • Synovium: The synovium is the tissue that lines the inside of your joints. It produces synovial fluid, which lubricates and nourishes the joints.
 

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 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

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.
  • 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: It is not known if ORENCIA for SC injection is safe and effective in children under 18 years of age.

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

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