ORENCIA® (Abatacept)

ORENCIA®

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Important Safety Information

ORENCIA® (abatacept) is used to alleviate symptoms of rheumatoid arthritis (RA) and psoriatic arthritis (PsA) in patients who are 18 years of age or older. It also reduces symptoms of Junveline Idiopathic Arthritis (JIA) in patients who are six years of age or older.

ORENCIA® should not be used concurrently with TNF blockers. Talk to your doctor if you are currently receiving treatment with certain biologic medications — including RITUXAN® (rituximab), SIMPONI ARIA® (golimumab), CIMZIA® (certolizumab pegol), ACTEMRA® (tocilizumab), HUMIRA® (adalimumab), REMICADE® (infliximab), Enbrel® (etanercept), or Kineret (anakinra). The intravenous version of ORENCIA® has not been studied in children under six years of age.

Do not receive live vaccines while taking ORENCIA® or for three months after ending treatment, as they may cause serious side effects. ORENCIA® may also cause other types of vaccination to become less effective.

What is the most important information I should know about ORENCIA®?

ORENCIA® may increase the risk of infections in patients who have a history of chronic infections, viral hepatitis, or tuberculosis (TB); or who have influenza or a small infection from a cut or sore. You will also need to be closely monitored if you have chronic obstructive pulmonary disease (COPD) or diabetes.

Tell your doctor about your medical history, including health conditions, vaccinations, surgeries, as well as medications you’re currently taking — whether they’re prescription, over-the-counter, herbal supplements, or vitamins. This will help determine whether ORENCIA® is right for you and what dosage is appropriate.

It is unknown whether ORENCIA® would harm an unborn child. Therefore, talk to your doctor if you are pregnant, think you may be pregnant, or are thinking about becoming pregnant during treatment. It is also unknown if ORENCIA® would pass on to your child through breast milk. Discuss your alternatives with your physician.

Side Effects of ORENCIA®

As with any prescription medication, ORENCIA® carries the risk of side effects. The most common ones include:

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

If the patient is a child, the most common side effects include:

  • Fever
  • Abdominal pain
  • Cough
  • Diarrhea

Allergic Reactions

Talk to your doctor if you experience breathing difficulties, hives, skin rash, or a swollen face, lips, tongue, or eyelids. If you have Hepatitis B, have your doctor run your bloodwork prior to starting treatment.

Serious Infections

Tell your doctor immediately if you experience a fever, flu-like symptoms, cough, warm, red, or painful skin, or fatigue, as ORENCIA® may increase your risk of developing serious infections.

Breathing Difficulties

ORENCIA® may cause you to develop breathing difficulties if you have chronic obstructive pulmonary disease (COPD). Tell your doctor immediately if you experience a cough, trouble breathing, or worsened COPD.

Malignant Tumors

It is unknown whether ORENCIA® increases the risk of certain types of cancer. However, malignancies have been reported in patients using ORENCIA®.

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

ORENCIA® is a prescription medication that reduces the symptoms of moderate to severe rheumatoid arthritis in patients for whom traditional forms of treatment have not been effective. It may also prevent further damage to bones and joints.

Please refer to the full prescribing information.