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Please read the Medication Guide for REMICADE® and discuss with your doctor.

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Understanding REMICADE

REMICADE is an advanced treatment that has been shown to have substantial benefits in patients with a number of inflammatory disorders involving the immune system. REMICADE targets specific proteins in the body's immune system to help control the development of inflammation, significantly reducing painful symptoms in diseases such as plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, adult Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, and ankylosing spondylitis.

How your immune system works

The immune system protects the body by responding to "invaders" like bacteria, viruses, and other foreign matter that enter your body by producing antibodies and putting them into action to fight off the "invaders". In diseases like plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, adult Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, and ankylosing spondylitis, TNF can cause your immune system to attack healthy tissues in your body and cause inflammation and damage. If these diseases are untreated, it can cause permanent damage to the body's bones, cartilage, and tissue.

The following diseases are known as autoimmune disorders:

plaque psoriasis
rheumatoid arthritis
Psoriatic arthritis
adult Crohn’s disease
pediatric Crohn’s disease
ulcerative colitis
ankylosing spondylitis

How REMICADE works on inflammatory disorders

REMICADE is a type of protein that recognizes, attaches to, and blocks the action of a substance in your body called tumor necrosis factor (TNF). TNF is made by certain blood cells in your body. REMICADE will not cure plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, adult Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, and ankylosing spondylitis, but blocking TNF with REMICADE may reduce the inflammation caused by TNF in your body. You should also know that REMICADE may help you feel better but can also cause serious side effects and can reduce your body's ability to fight infections.

For more detailed information, please visit the following resources:

IMPORTANT SAFETY INFORMATION

How will my doctor decide if REMICADE^® is right for me?

Only your doctor can recommend a course of treatment after checking your health condition. Your doctor should discuss with you any potential benefits and risks and help you make the best treatment decision. While REMICADE^® may help you feel better, like other medicines that affect your immune system, it can cause serious side effects such as lowering your ability to fight infections. There are reports of serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE.^® You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take REMICADE^®?

You should let your doctor know if you have or ever had any of the following:

Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE.^®
Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
An infection that keeps coming back (or any problems that increase the risk of infection) or have diabetes.
Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
Heart failure or any heart condition. Many people with heart failure should not take REMICADE.^®
Hepatitis B virus (HBV) infection or think you may be a carrier of HBV.
Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).

Also tell your doctor about any medications you are taking, including vaccines or Kineret (anakinra), and if you are pregnant, plan to become pregnant or are nursing. Adults and children should not receive a live vaccine while taking REMICADE.^®

What should I watch for and talk to my doctor about before or while taking REMICADE^®?

The following serious (sometimes fatal) side effects have been reported in people taking REMICADE.^®

You should tell your doctor right away if you have any of the signs listed below:

Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE^® can make you more likely to get an infection or make any infection that you have worse.
Lymphoma, or any other cancers. A rare form of fatal lymphoma has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE^® and azathioprine or 6-mercaptopurine.
Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
Blood disorders—fever that doesn't go away, bruising, bleeding or severe paleness.
Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun. The more common side effects with REMICADE^® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.

Medication Guide for REMICADE^®

Please read the Medication Guide for REMICADE^® and discuss with your doctor.
(Requires Adobe^® Acrobat^® Reader^®. Click here to download.)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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Last Updated: January 19, 2009