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  • 1-800-ORENCIA

The site is intended for US residents 18 years of age or older.

 

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).

Adult Psoriatic Arthritis (PsA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults with active Psoriatic Arthritis (PsA). In adults, ORENCIA may be used alone or with other PsA treatments.

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ORENCIA® (abatacept) Side Effects

The following information describes the serious side effects of ORENCIA that you should be aware of. See the most common side effects of ORENCIA listed below. These are not all of the possible side effects of ORENCIA. Ask your doctor what to do if you experience any side effects.

This is a list of some of the possible side effects of ORENCIA for your reference.

Talk to your rheumatologist about any side effect that may be bothering you. Your rheumatologist can work with you to manage side effects throughout your treatment.

Serious side effects

Serious side effects are those that may require medical treatment or hospitalization, cause permanent damage, or be life-threatening or sometimes even fatal. Talk to your healthcare provider about any concerns you may have.

• Infections. ORENCIA can make you more likely to get infections or make the infections that you have worse. In some cases, these infections have been fatal. Symptoms of an infection include:

  • Fever
  • Cough
  • Warm, red, or painful skin
  • Feeling very tired
  • Flu-like symptoms
  • Fever
  • Cough
  • Warm, red, or painful skin
  • Feeling very tired
  • Flu-like symptoms

Call your healthcare provider right away if you feel sick or have any of the symptoms of an infection.

• Allergic reactions. Allergic reactions can happen with ORENCIA. Symptoms of an allergic reaction may include:

  • Hives
  • Swollen face, eyelids, lips, or tongue
  • Trouble breathing

Seek urgent medical attention if you have any of the symptoms of an allergic reaction.

If you have the hepatitis B virus, talk to your healthcare provider as hepatitis B can become an active infection while you use ORENCIA. Your rheumatologist may do blood tests before treatment with ORENCIA to check if you have hepatitis B.

• If you are receiving or are scheduled to receive vaccinations, it is important to know that:

  • You should not receive live vaccines while taking ORENCIA and for 3 months after ending treatment, as it may cause serious side effects.
  • ORENCIA may also cause some other vaccinations to be less effective.

Talk to your rheumatologist about your vaccination plans.

If you have Chronic Obstructive Pulmonary Disease (COPD), you may experience breathing problems more often while taking ORENCIA. Call your healthcare provider if you experience any of the following:

  • Worsened COPD
  • Cough
  • Trouble breathing

• Certain kinds of cancer (malignancies) have been reported in people using ORENCIA. It is not known if ORENCIA increases your chances of developing certain kinds of cancer.


Most common side effects

The most common side effects of ORENCIA include:

    • Headache
    • Upper respiratory tract infection
    • Sore throat
    • Nausea

In children and adolescents, other side effects may include:

    • Diarrhea
    • Cough
    • Fever
    • Abdominal pain

These are not all of the possible side effects of ORENCIA. If you have any questions or want more information about side effects, ask your rheumatologist or healthcare provider.


If you experience any side effects and would like to report them to the FDA, you can call
1-800-FDA-1088.

 

There are 3 ways to receive ORENCIA

Each way is approved for different ages:

ORENCIA IV is approved for patients 6 years and older. ORENCIA IV has not been studied in patients younger than 6 years of age.

ORECIA prefilled syringe is approved for patients 2 years and older.

ORENCIA ClickJectTM 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.

Most common side effects of
ORENCIA

The safety of ORENCIA was studied across all the clinical trials. Here are the side effects that occurred in at least 3% of patients who took ORENCIA, and at least 1% more frequently in ORENCIA-treated patients across all trials.

  • ORENCIA + disease-modifying antirheumatic drugs (DMARDs) (1955 patients)
  • DMARDs only (989 patients)


*Nasopharyngitis: Inflammation of the nose and throat (characterized by sneezing, stuffy nose, cough, sore throat)

Please read the Important Facts About ORENCIA presented below.

Important Facts About ORENCIA® (abatacept)

This is a summary of important information that you need to know in order to take ORENCIA safely. Work with the rheumatologist to make the treatment suitable and safe for you or your loved one.

  • Look out for the following icons as you read:

  • Talk to your rheumatologist

  • Call a healthcare provider right away

  • Helpful information to remember

 

What is ORENCIA?

ORENCIA (abatacept) is a prescription biologic medicine for:

Adult Rheumatoid Arthritis (RA)

ORENCIA is used to reduce signs and symptoms of moderate to severe Rheumatoid Arthritis (RA) in adults 18 years and older. Taking ORENCIA may prevent further damage to your bones and joints, and may help your ability to perform daily activities. ORENCIA may help those who are not getting the results they need with other medicines for RA.

In adults, ORENCIA may be used alone or with other RA treatments, but should not be used with TNF-blockers (also called Tumor Necrosis Factor antagonists). TNF-blockers are a type of RA medication, and include such treatments as Enbrel® (etanercept), Humira® (adalimumab), and
Remicade® (infliximab).

Juvenile Idiopathic Arthritis (JIA)

ORENCIA is used to reduce signs and symptoms of moderate to severe polyarticular JIA in patients 2 years of age and older. ORENCIA may be used alone or with methotrexate (MTX).

Adult Psoriatic Arthritis (PsA)

ORENCIA is used to reduce signs and symptoms of active Psoriatic Arthritis (PsA) in adults 18 years and older. In adults, ORENCIA may be used alone or with other PsA treatments.

  • ORENCIA is for adults 18 years and older with moderate to severe RA.
  • ORENCIA is for patients 2 years of age and older with moderate to severe polyarticular JIA.
  • ORENCIA is for adults 18 years and older with active PsA.
  • ORENCIA should not be used with TNF-blockers.
  • ORENCIA has not been studied in children under 2 years of age.
  • ORENCIA has not been studied in children for uses other than JIA.

ORENCIA is available in two forms:

ORENCIA intravenous (IV) infusion is given by your healthcare provider through a vein in your arm.

  • ORENCIA IV is approved for patients 6 years and older.
  • ORENCIA IV has not been studied in children under the age of 6.
OR

ORENCIA subcutaneous (SC) injection is a shot that is given just under your skin. It is available as a prefilled syringe or a ClickJect™ Autoinjector.

  • ORENCIA SC prefilled syringe is available for patients 2 years and older.
  • ORENCIA ClickJect™ Autoinjector has not been studied in children under 18 years of age.
  • Talk to your rheumatologist about the best way for you or your child to receive ORENCIA.
 

What should I discuss with my rheumatologist before starting ORENCIA?

  • Talk to your rheumatologist about all of your medical conditions, including if:
    • You have any kind of infection, as you may have a higher chance of getting serious side effects from an infection while taking ORENCIA. Infections include:
      • Small infections (such as an open cut or sore) to whole body infections (such as the flu).
      • Any infection that will not go away or a history of infections that keep coming back.
      • Viral hepatitis, a viral infection that affects the liver. Tell your rheumatologist if you have or have ever had viral hepatitis. Before starting ORENCIA, your rheumatologist may examine you for hepatitis.
      • Tuberculosis (TB), a type of lung infection. Tell your rheumatologist if you have ever had TB or a positive skin test for TB, or have recently been in close contact with someone who has ever had TB. Before starting ORENCIA, your rheumatologist may check you for TB or do a skin test. Call your rheumatologist if you notice any symptoms of TB, including: a cough that does not go away, weight loss, fever, or night sweats.
    • You have allergies to the ingredients of ORENCIA. For a list of ingredients, see What are the ingredients in ORENCIA? in the Patient Information section of the Full Prescribing Information.
    • You have Chronic Obstructive Pulmonary Disease (COPD), a type of lung disease.
    • You have diabetes. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels on the day that you receive ORENCIA IV infusion. ORENCIA IV contains maltose, which can alter the blood sugar readings with certain types of blood glucose monitors.
  • Tell your rheumatologist about all of your medical treatments, including if:
    • You are scheduled to have surgery.
    • You recently received or are scheduled to receive vaccinations.
    • You are taking:
      • Other medications for RA, JIA, or PsA.
      • Prescription medications or over-the-counter medications.
      • Vitamins or herbal supplements.
  • Let your rheumatologist know if you are a woman who is:
    • Pregnant or considering pregnancy. It is not known if ORENCIA can harm an unborn baby. If ORENCIA is taken during pregnancy, talk to your healthcare provider before your baby receives any vaccines.
    • Breastfeeding or planning to breastfeed. It is not known if ORENCIA passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ORENCIA.
 

What should I avoid while I am on ORENCIA?

ORENCIA and other medicines may affect each other, which could cause serious side effects. You should avoid taking ORENCIA with other biologics that may affect your immune system. Doing so may increase your chances of getting a serious infection.

  • Tell your rheumatologist if you are taking other biologic medicines, such as:
  • Enbrel® (etanercept)
  • Humira® (adalimumab)
  • Remicade® (infliximab)
  • Kineret® (anakinra)
  • Rituxan® (rituximab)
  • Simponi® (golimumab)
  • Cimzia® (certolizumab pegol)
  • Actemra® (tocilizumab)
  • Talk to your rheumatologist and your other healthcare providers before you begin to take anything new or if you have any changes to your medications during your treatment with ORENCIA. It is a good idea to keep an up-to-date list of all of your medicines, vitamins, and herbal supplements on hand to show your doctors and pharmacists.
 

What are the possible side effects of ORENCIA?

This is a list of some of the possible side effects of ORENCIA for your reference.

  • Talk to your rheumatologist about any side effect that may be bothering you. Your rheumatologist can work with you to manage side effects throughout your treatment.

Serious side effects
Serious side effects are those that may require medical treatment or hospitalization, cause permanent damage, or be life-threatening or sometimes even fatal. Talk to your healthcare provider about any concerns you may have.

  • Infections. ORENCIA can make you more likely to get infections or make the infections that you have worse. In some cases, these infections have been fatal. Symptoms of an infection include:
    • Fever
    • Cough
    • Warm, red, or painful skin
    • Feeling very tired
    • Flu-like symptoms
  • Call your healthcare provider right away if you feel sick or have any of the symptoms of an infection.
  • Allergic reactions. Allergic reactions can happen with ORENCIA. Symptoms of an allergic reaction may include:
    • Hives
    • Swollen face, eyelids, lips, or tongue
    • Trouble breathing
  • Seek urgent medical attention if you have any of the symptoms of an allergic reaction.
  • If you have the hepatitis B virus, talk to your healthcare provider as hepatitis B can become an active infection while you use ORENCIA. Your rheumatologist may do blood tests before treatment with ORENCIA to check if you have hepatitis B.
  • If you are receiving or are scheduled to receive vaccinations, it is important to know that:
    • You should not receive live vaccines while taking ORENCIA and for 3 months after ending treatment, as it may cause serious side effects.
    • ORENCIA may also cause some other vaccinations to be less effective.
  • Talk to your rheumatologist about your vaccination plans.
  • If you have Chronic Obstructive Pulmonary Disease (COPD), you may experience breathing problems more often while taking ORENCIA. Call your healthcare provider if you experience any of the following:
    • Worsened COPD
    • Cough
    • Trouble breathing
  • Certain kinds of cancer (malignancies) have been reported in people using ORENCIA. It is not known if ORENCIA increases your chances of developing certain kinds of cancer.

Most common side effects
The most common side effects of ORENCIA include:

    • Headache
    • Upper respiratory tract infection
    • Sore throat
    • Nausea

In children and adolescents, other side effects may include:

    • Diarrhea
    • Cough
    • Fever
    • Abdominal pain

These are not all of the possible side effects of ORENCIA. If you have any questions or want more information about side effects, ask your rheumatologist or healthcare provider.

If you experience any side effects and would like to report them to the FDA, you can call 1-800-FDA-1088.

 

How will I receive ORENCIA?

ORENCIA is available in two forms, as intravenous (IV) infusions and as subcutaneous (SC) injections. Work with your rheumatologist to determine the right treatment plan for you or your child.

ORENCIA IV infusion is given by a healthcare provider through a vein in your arm.

  • ORENCIA IV is approved for children 6 years and older.
  • ORENCIA IV has not been studied in children under the age of 6. 
    • You will receive your first three infusions 2 weeks apart from each other (Weeks 0, 2, and 4). After that, you will receive an infusion every 4 weeks.
    • Each infusion takes about 30 minutes, though actual time in the clinic will be longer.

ORENCIA SC injection is a shot that is given just under your skin. It is available as a prefilled syringe or ClickJect™ Autoinjector.

  • ORENCIA SC prefilled syringe is available for patients 2 years and older.
  • ORENCIA ClickJect™ Autoinjector has not been studied in children under 18 years of age.

If your rheumatologist decides that your injections can be given at home, you or your caregiver will receive training on how to prepare and inject ORENCIA. Do not try to inject ORENCIA until you have been shown the right way by your rheumatologist or healthcare provider.

  • You will use ORENCIA SC injection once weekly.
  • For more information about preparing and giving ORENCIA SC injections at home, see Instructions for Use in the Patient Information section of the Full Prescribing Information.
    Please talk to your healthcare provider about the best way to receive ORENCIA.

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

More Important Facts

Selected Important Facts About ORENCIA® (abatacept)

ORENCIA can cause serious side effects, including serious infections, allergic reactions, hepatitis B infection in carriers of the virus, interactions with vaccines, respiratory problems with chronic obstructive pulmonary disease (COPD), and cancer. Side effects of ORENCIA which are considered common include: headache, upper respiratory tract infection, sore throat, and nausea. Other side effects in children and adolescents include diarrhea, cough, fever, and abdominal pain.

This is not a complete list of all side effects with ORENCIA. Tell your healthcare provider if you have any side effects while taking ORENCIA. For more information, please read the Important Facts throughout this website.