Indication and Safety Information for REMICADE

REMICADE has been used to treat more than one million patients worldwide for conditions like plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, Crohn’s disease in adults, pediatric Crohn’s disease, ulcerative colitis, and ankylosing spondylitis. The safety profile of REMICADE has been evaluated through medical trials conducted over the past 16 years.

Indications

• Plaque Psoriasis
  REMICADE is approved for the treatment of adult patients with chronic severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if REMICADE is appropriate considering other available therapies.
• Rheumatoid Arthritis
  REMICADE, used in combination with methotrexate, can reduce signs and symptoms, help stop further joint damage, and improve physical function in many patients with moderate to severe RA.
• Psoriatic Arthritis
  REMICADE can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in many patients with psoriatic arthritis.
  
• Adult Crohn's Disease
  REMICADE is for patients with moderate to severe Crohn’s who haven't responded well to other therapies.
• Pediatric Crohn's Disease
  REMICADE is for children (ages 6-17) with moderate to severe Crohn's disease who haven't responded well to other therapies.
• Ulcerative Colitis
  REMICADE can reduce the signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in patients with moderate to severe UC who haven't responded well to other therapies.
• Ankylosing Spondylitis
  REMICADE is for patients with active ankylosing spondylitis.

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.