Remicade Treatment

WHAT IS REMICADE?

Remicade is a medication that is used to treat adults with moderate Crohn's and Ulcerative Colitis disease. Your doctor has decided to treat you with Remicade because your disease is still active even though you have tried other treatments.

HOW DOES REMICADE WORK?

The medicine Remicade is a type of protein that recognizes, attaches to and blocks the action of a substance in your body called tumor necrosis factor alpha (TNF-alpha). TNF-alpha is a natural substance made by certain blood cells in your body. TNF-alpha delivers messages between cells in your body, but too much TNF-alpha can cause your immune system to attack healthy tissues in your body and cause inflammation. There is no cure for Crohn's disease or Ulcerative Colitis, but blocking TNF-alpha with Remicade can reduce inflammation. You should also know that by blocking TNF-alpha, Remicade can reduce your immune system's ability to fight infection.

WHAT SHOULD I KNOW ABOUT THE IMMUNE SYSTEM, AND TAKING REMICADE FOR CROHN'S OR ULCERATIVE COLITIS DISEASE?

The immune system protects the body by responding to invading material like bacteria, viruses and other foreign matter by producing antibodies and putting them into action to fight off the "invaders". In both Crohn's disease and Ulcerative Colitis, your body's immune system produces too much TNF-alpha as part of your immune system's response. Too much TNF-alpha can cause inflammation and if left untreated can cause permanent damage to the body's bones, cartilage and tissues.

Taking Remicade can block TNF-alpha that causes inflammation but it can also lower your immune system's ability to fight off infections. So taking Remicade can make you more prone to getting infections or can make an existing infection worse. You should call your doctor right away if you think you have an infection.

WHO SHOULD NOT TAKE REMICADE?

You should not take Remicade if you have:

• An infection that you are being treated for. If you have or think you may have an infection, ask your doctor if it is the kind of infection that could put you at risk for serious side effects from Remicade.
• An allergy to any of the ingredients in Remicade (sucrose, sodium phosphate and polysorbate 80).
• An allergy to murine (mouse) protiens.

WHAT HEALTH CONCERNS SHOULD I TALK TO MY DOCTOR ABOUT?

Before receiving your first treatment with Remicade you should tell your doctor if you:

• Have an infection that won't go away or a history of infection that keeps coming back.
• Have lived in an area of the country where an infection called histoplasmosis (an infection caused by a fungus that affects the lungs) is common. If you don't know if the area you live in is one that is common for histoplasmosis, ask your doctor.
• Have had TB (tuberculosis), or if you have recently been with anyone who might have TB. Your doctor will examine you for TB and perform a skin test. If your doctor feels that you are at risk for TB, he or she may start treating you for TB before you begin Remicade therapy.
• Have or have had a disease that affects your nervous system, like multiple sclerosis or if you experience any numbness or tingling.
• Are pregnant or nursing.
• Have recently received or are scheduled to receive a vaccine.

WHAT IMPORTANT INFORMATION SHOULD I KNOW ABOUT TREATMENT WITH REMICADE?

Remicade, like other medicines that affect your immune system, is a strong medicine that can cause serious side effects. Possible serious side effects include:

• Serious infections: Some patients have had serious infections while receiving Remicade. Some people have died from these infections. These serious infections include TB (tuberculosis), and infections caused by fungi or bacteria that have spread throughout the body. If you develop a fever, feel very tired, have a cough, or have flu-like symptoms, these could be signs that you may be getting an infection. If you have any of these symptoms while you are taking or after you have taken Remicade, you should tell your doctor right away
• Allergic Reactions: Some patients have severe allergic reactions to Remicade. These reactions can happen while you are getting your Remicade infusion or shortly afterwards. The symptoms of an allergic reaction may include hives (red, raised, itchy patches of skin), difficulty breathing, chest pain and high or low blood pressure. Your doctor may decide to stop Remicade treatment and give you medications to treat the allergic reaction. Some patients who have been taking Remicade have had allergic reactions three (3) to twelve (12) days after receiving their Remicade treatment. The symptoms of this type of delayed reaction may include muscle or joint pain with fever or rash. Tell your doctor if you have any of these symptoms or any other unusual symptoms.
• Lupus-like Symptoms: Some patients have developed symptoms that can resemble lupus. Lupus-like symptoms may include lasting chest discomfort or pain, shortness of breath, joint pain or a rash on the cheeks or arms that is sensitive to the sun. If you develop any of these symptoms, your doctor may decide to stop your treatment with Remicade.

WHAT ARE OTHER POSSIBLE SIDE EFFECTS OF REMICADE

The most common side effects of Remicade are respiratory infections (such as bronchitis, sinus infections, cold, sore throat, coughing, nausea, stomach pain, upset stomach, back pain, diarrhea, headache, dizziness, tiredness, itchiness and urinary tract infections.

The most common reasons that patients have stopped treatment are shortness of breath, rash and headache. As described above, sometimes these side effects can be serious and may require other treatment.

CAN I TAKE REMICADE WHILE I AM ON OTHER MEDICINES?

Tell your doctor if you are taking other medications before starting Remicade and while taking Remicade. Also, tell your doctor if you plan to take other medications.

HOW WILL REMICADE BE GIVEN TO ME?

G.I. Medicine administers Remicade inthe infusion room. Remicade will be given to you by a medical or health care professional. Remicade will be given to you by an intravenous infusion (IV). This means that the medicine will be given to you through a needle placed in your arm. It will take about 2 to 6 hours to give you the full dose of medicine. During that time and for a period after you receive Remicade, you will be monitored by a health care professional. Your doctor may ask you to take other medicines along with Remicade.

WHAT IF I STILL HAVE QUESTIONS?

If you have any questions or problems, always talk first with your doctor. You can also visit the Remicade internet site at www.remicade.com