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Drug Factsheets

Orencia

(abatacept)

DIN (Drug Identification Number)

02282097 ORENCIA 250MG/VIAL IV SOLUTION

What side effects are possible with Orencia?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • cough
  • diarrhea
  • dizziness
  • fatigue
  • flushing
  • headache
  • heartburn
  • nausea
  • rash
  • sore throat
  • stomach or abdominal pain
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • fever or chills
  • signs of a skin infection (e.g., redness, inflammation, swelling, warmth)
  • signs of a urinary tract or kidney infection (e.g., pain or burning sensation when urinating, frequent urination, blood in the urine, back pain)
  • signs of an intestinal infection (e.g., abdominal pain, change in bowel habits, fever, nausea)
  • signs of pneumonia or bronchitis (e.g., cough, fever, shortness of breath, chest pains)
  • upper respiratory infections (e.g., colds, sore throats, or sinus infections) - especially if symptoms won't go away or keep coming back

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of an allergic reaction (e.g., difficulty breathing, hives, swelling of the face or throat, chest pain)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.



Are there any other precautions or warnings for Orencia?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: In rare cases, some people may develop an allergic reaction to this medication. Signs of an allergic reaction include a severe rash, swollen face, chest pain, or difficulty breathing. If these occur, contact your doctor immediately.

Blood glucose: This medication may affect blood glucose testing by giving falsely high blood glucose readings with certain types of blood glucose monitors. If you require blood glucose monitoring, talk to your doctor or pharmacist about using a blood glucose monitor that will not be affected by this medication.

Cancer: In clinical trials, people using abatacept reported developing lung cancer or a cancer of the immune system (known as lymphoma) more often than people who were treated with placebo. Other types of cancer have also been reported. The number of reported cancer cases in people taking abatacept appears to be consistent with the expected number of cancer cases reported in people with rheumatoid arthritis. In general, people with severe rheumatoid arthritis who have had the condition for a long time may also have a higher risk of developing lymphoma. If you take abatacept or other rheumatoid arthritis biologic medication, your risk may increase. The role of abatacept in the development of cancer is not known.

Chronic obstructive pulmonary disease (COPD): People with COPD have a higher risk of experiencing side effects when they are using abatacept. If you have COPD, your doctor will monitor you for signs of worsening disease.

Infections: This medication can increase the risk of developing an infection. If you notice signs of an infection, such as fever, chills, pain, swelling, or pus, contact your doctor as soon as possible. Also, this medication should not be started while you have an active or chronic infection. This medication should not be used by people who have active tuberculosis or if you come in contact with someone who has tuberculosis. Your doctor may examine you for tuberculosis and give you a skin test before you start abatacept.

People infected with hepatitis B virus (an infection that can damage the liver) have had a relapse of their condition while taking medications for rheumatoid arthritis. To determine if you are at risk for hepatitis B, your doctor may test you for this infection before starting treatment with abatacept and will follow your condition closely while you are taking the medication. If you notice symptoms of liver problems, such as abdominal pain, yellow eyes or skin, loss of appetite, fatigue, or dark urine, contact your doctor immediately.

Use with other biologics: This medication should not be used at the same time with a class of medications called biologic response modifiers ("biologics") and other such medications (e.g., anakinra, etanercept, infliximab, adalimumab, rituximab). Doing so could increase the risk of infections.

Vaccines: Live vaccines should not be given during treatment with abatacept or within 3 months of stopping abatacept. Children who have JIA or JRA should complete the recommended vaccination schedule before starting treatment with abatacept.

Pregnancy: There have been no studies on the use of abatacept by pregnant women. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if abatacept passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children under 6 years of age.

Seniors: Seniors may be more likely to experience serious infections and cancer with abatacept. Talk to your doctor about the risks and benefits of using this medication.

What other drugs could interact with Orencia?

There may be an interaction between abatacept and any of the following:

  • adalimumab
  • anakinra
  • certolizumab
  • etanercept
  • golimumab
  • infliximab
  • live vaccines (e.g., measles, mumps, and rubella (MMR), tuberculosis (BCG), yellow fever)
  • pimecrolimus
  • rituximab
  • roflumilast
  • tacrolimus

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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