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

What is Juvenile Idiopathic Arthritis
(JIA)?

Juvenile idiopathic arthritis (JIA), is an autoimmune disease that affects children
and adolescents
. Like adult rheumatoid arthritis (RA), JIA causes chronic pain, stiffness, and swelling of the joints.

ORENCIA® (abatacept) 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).

The main symptoms children and teens with JIA may experience are:

Pain, swelling, and stiffness in the joints.

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.


What can you do if your child has been diagnosed with moderately to severely active polyarticular JIA?

If your child has JIA:

  • Learn all you can about your child's condition
  • Get helpful advice, information, and support by joining a local support group
  • Find out about treatment options, including the possible benefits and risks
  • Ask your doctor if ORENCIA® (abatacept) intravenous (IV) infusion may be appropriate for your child

Selected Important Safety Information

ORENCIA can cause serious side effects including:

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.


How can ORENCIA IV help children
and teens with moderate to severe JIA?

ORENCIA IV has been shown to reduce pain and joint inflammation in children 6 years of age and older with moderately to severely active polyarticular JIA. Studies have shown that ORENCIA IV has helped children and teens experience fewer flares.

ORENCIA IV is given to your child as a 30-minute infusion by a health care professional. It is given once every 4 weeks after an initial dosing regimen.

Tell your doctor if your child has an infection, even if it is small (such as an open cut or sore) or an infection that is in their whole body (such as the flu). Also tell your doctor if your child has recently received a vaccination or is scheduled for any vaccination.

There are three ways to receive 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 patients 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 doctor about the best way for your child to receive ORENCIA.


Interested in more information about ORENCIA?

ORENCIA On Callâ„¢

Managing moderate to severe polyarticular JIA can be challenging. We are here to help, whether your child
is taking ORENCIA or exploring it as a treatment option.
All you have to do is sign up for ORENCIA On Call.*

With ORENCIA On Call, there is always a real
person—someone who has experience working with
people like you—just a phone call or click away.

ORENCIA On Call provides free services, including:

  • Live Chat*
  • Personal Care Counselor†‡
  • Talk to a trained nurse
  • Help understanding your insurance coverage

*Terms and Conditions apply.
Live chat is available 8 AM to midnight EST. ORENCIA Care Counselors are available 24/7 at 1-800-ORENCIA (1-800-673-6242).

Neither the Care Counselor nor the nurse can provide medical advice. Your
child's doctor is the best source of information about your child's health.

Sign up for ORENCIA
On Call now

OR Call 1-800-ORENCIA

ORENCIA nurses are available for assistance Monday through Friday, 8 AM to 8 PM EST. At all other times, nurses will usually return your calls within 30 to 60 minutes.

 

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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