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IMPORTANT WARNING:   Infliximab (is a monoclonal antibody)  may decrease your ability to fight infection and increase the risk that you will get a serious or life-threatening infection. Tell your doctor if you have any type of infection now, including minor infections (such as open cuts or sores), infections that come and go (such as cold sores) and chronic infections that do not go away, or if you often get any type of infection such as bladder infections. Also tell your doctor if you are taking medications that suppress the immune system such as azathioprine (Imuran), cancer chemotherapy medications, cyclosporine (Neoral, Sandimmune), oral corticosteroids; 6-mercaptopurine (Purinethol); methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf). If you experience any of the following symptoms during or shortly after your treatment with infliximab, call your doctor immediately: sore throat; cough; fever; extreme tiredness; flu-like symptoms; warm, red, or painful skin; or other signs of infection.

Infliximab increases the risk that you will get some types of infections that are most common in certain parts of the United States and the world. Tell your doctor all the places you previously lived and all the places you recently visited or plan to visit while using infliximab.

You may be infected with tuberculosis (TB, a type of lung infection) but not have any symptoms of the disease. In this case, infliximab may increase the risk that your infection will become more serious and you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medication to treat this infection before you start using infliximab. Tell your doctor if you have or have ever had TB, or if you have been around someone who has TB.

Keep all appointments with your doctor. Your doctor will monitor your health carefully to be sure you do not develop a serious infection.

Some children and young adults with Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) who used infliximab developed a rare type of cancer called hepatosplenic T-cell lymphoma. These patients were also taking azathioprine (Imuran) or 6-mercaptopurine (Purinethol) when they developed this cancer.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with infliximab and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using infliximab.

Read more:

 http://www.nlm.nih.gov/medlineplus/druginfo/meds/a604023.html



IMPORTANT SAFETY INFORMATION

RISK OF INFECTIONS

Patients treated with REMICADE® are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue REMICADE® if a patient develops a serious infection or sepsis.

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