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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 healthcare provider to make the treatment suitable and safe for you or your loved one. Keep this information, so you can refer to it before and during your treatment.

Look out for the following icons as you read:

  • Talk to your healthcare provider

  • 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 other than Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (bDMARDs), such as tumor necrosis factor (TNF) antagonists (also called TNFblockers). TNF-blockers are a type of RA medication, and include such treatments as Enbrel® (etanercept), Humira® (adalimumab), and Remicade® (infliximab).

Polyarticular Juvenile Idiopathic Arthritis (pJIA):

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).

Psoriatic Arthritis (PsA)

ORENCIA is used to reduce signs and symptoms of active Psoriatic Arthritis in people 2 years of age and older. In adults, ORENCIA may be used alone or with other non-biologic PsA treatments. In children, ORENCIA can be used alone or with methotrexate.

ORENCIA should not be used with other strong medicines that affect the immune system, such as bDMARDs and JAK inhibitors.

  • 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 pJIA or active PsA.
  • ORENCIA should not be used with bDMARDs and JAK
    inhibitors.
  • ORENCIA has not been studied in children under 2 years
    of age.
  • ORENCIA has not been studied in children for uses other
    than pJIA.
 

What should I discuss with my healthcare provider before starting ORENCIA?

  • Talk to your healthcare provider 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 healthcare provider if you have or have ever had viral hepatitis. Before starting ORENCIA, your healthcare provider may examine you for hepatitis.
      • Tuberculosis (TB), a type of lung infection. Tell your healthcare provider 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 healthcare provider may check you for TB or do a skin test. Call your healthcare provider 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. and use a blood glucose monitor to check your blood sugar (blood glucose) levels.
      • ORENCIA for IV (given through a needle placed in a vein) contains maltose, a type of sugar, that can give false high blood sugar readings with certain types of blood glucose monitors on the day of ORENCIA infusion. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels.
      • ORENCIA for SC injection (injected under the skin) does not contain maltose. You do not need to change your blood sugar monitoring if you are using ORENCIA subcutaneously.
    • You have a family or personal history of skin cancer, or see any growths or changes in the appearance of your skin during or after treatment with ORENCIA. Some people treated with ORENCIA have developed skin cancer.
  • Tell your healthcare provider about all of your medical treatments, including if:
    • You are scheduled to have surgery.
    • You recently received or are scheduled to receive vaccinations. If you are receiving ORENCIA, and for 3 months after you stop receiving ORENCIA, you should not take live vaccines.
    • You are taking:
      • Other medications for RA, pJIA, or PsA.
      • Prescription medications or over-the-counter medications.
      • Vitamins or herbal supplements.
  • Let your healthcare provider 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.
    • There is a registry for pregnant women exposed to ORENCIA. The purpose of this registry is to check the health of the pregnant mother and her child. Women are encouraged to call the registry themselves or ask their healthcare provider to contact the registry for them by calling
      1-877-311-8972.
    • 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 healthcare provider 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 healthcare provider 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 healthcare provider about any side effect that may be bothering you. Your healthcare provider 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 healthcare provider 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.
    • You can receive non-live vaccines, such as pneumococcal and inactivated influenza (flu) vaccines.
    • ORENCIA may also cause some other vaccinations to be less effective.
  • Talk to your healthcare provider 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 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 healthcare provider 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.
  • ORENCIA IV is not approved for PsA in children. 
  • 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.

  • pJIA and pediatric PsA patients may self-inject with ORENCIA or the patient’s caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determine it is appropriate.
  • The ability of pediatric patients to
    self-inject with the autoinjector has not been tested.

If your healthcare provider 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 healthcare provider.


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427-US-2300232 Jan/24