"Patients with psoriatic arthritis (PsA) may be at increased risk for experiencing significant cardiovascular (CV) events, a new study suggests.
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Orencia Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: shortness of breath, change in the amount of urine, pain when urinating, severe abdominal pain.
Because abatacept works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor immediately if you have any signs of infection (such as cough, sore throat, fever, chills, pain when urinating).
The immune system is also important in preventing and controlling cancer. Very rarely, patients using abatacept have developed cancer (e.g., lymphoma, lung cancer). Tell your doctor immediately if you develop symptoms such as unusual lumps/growths, swollen glands, night sweats, unexplained weight loss, shortness of breath, wheezing, persistent cough.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Orencia (abatacept) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using abatacept, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: chronic obstructive pulmonary disease-COPD, current/recent/returning infection (e.g., tuberculosis, hepatitis virus), cut or open sore, cancer, immune system disorder (e.g., HIV infection, bone marrow disorder), diabetes (especially if you are checking your blood sugar level at home).
Before having surgery, tell your doctor or dentist that you are using this medication.
Do not have immunizations/vaccinations while using this medication or up to 3 months after stopping this medication without the consent of your doctor. Also avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.
It is recommended that children be up to date on all their childhood vaccinations before starting abatacept.
Abatacept can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
Some abatacept products are made with maltose. This substance can cause false high blood sugar levels when your blood sugar is normal or even low. If you have diabetes, check with your pharmacist whether the product you are using contains maltose and whether your blood sugar testing supplies will work with this product. Rarely, serious problems have occurred when too much insulin was given because of false high sugar readings or when low blood sugar went untreated.
Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially increased risk of infections.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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