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Brand Names: Remicade

Generic Name: infliximab (Pronunciation: in FLIX ih mab)

• What is infliximab (Remicade)?
• What are the possible side effects of infliximab (Remicade)?
• What is the most important information I should know about infliximab (Remicade)?
• What should I discuss with my healthcare provider before using infliximab (Remicade)?
• How should I use infliximab (Remicade)?
• What happens if I miss a dose (Remicade)?
• What happens if I overdose (Remicade)?
• What should I avoid while using infliximab (Remicade)?
• What other drugs will affect infliximab (Remicade)?
• Where can I get more information?

What is infliximab (Remicade)?

Infliximab reduces the effects of a substance in the body that can cause inflammation.

Infliximab is used to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease, and ankylosing spondylitis. Infliximab is also used to treat severe or disabling plaque psoriasis (raised, silvery flaking of the skin).

Infliximab is often used when other medicines have not been effective.

Infliximab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of infliximab (Remicade)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with infliximab. Stop using infliximab and call your doctor right away if you have signs of infection such as:

• fever, sweating, chills, tired feeling;
• feeling short of breath;
• cough, sore throat;
• flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:

• chest pain, ongoing cough, coughing up blood;
• shortness of breath with swelling of your ankles or feet;
• numbness or tingling;
• weak feeling in your arms or legs;
• problems with vision;
• seizure (convulsions);
• pain or burning when you urinate;
• easy bruising or bleeding, pale skin, unusual weakness;
• red, purple, or scaly skin rash, hair loss, joint or muscle pain, mouth sores; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• stuffy nose, sinus pain;
• mild stomach pain;
• mild skin rash; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about infliximab (Remicade)?

Before you start treatment with infliximab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Serious and sometimes fatal infections may occur during treatment with infliximab. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or if you feel short of breath.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Infliximab can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Do not receive a "live" vaccine while you are being treated with infliximab.

Using infliximab may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes) or autoimmune disorders (such as a lupus-like syndrome). This risk may be greater in children and young adults. Talk to your doctor about your specific risk.