The Importance of Early Treatment

Childhood and adolescence are crucial times for physical and emotional growth. Therefore, it is important that pediatric Crohn’s patients receive effective treatment as early as possible. It is also important that pediatric Crohn’s be properly treated and managed in order to prevent any physical, emotional, or social problems that your child may face.

Crohn’s disease causes diarrhea, abdominal pain, bloody stools, reduced appetite, and weight loss. Such symptoms may lead to longer-term effects, such as malnutrition and abnormal growth.

Certain Crohn’s treatments, such as steroids, can also interfere with the natural growth process. That’s why you should talk to your child’s doctor about REMICADE. REMICADE is an advanced treatment that blocks a substance called TNF-alpha, which can cause inflammation in the intestines.

The following are some other reasons your child may benefit from REMICADE:

REMICADE is infused right into the bloodstream, so it gets to work fast.
REMICADE may eliminate steroid use. Stopping steroid use may allow your child to avoid the potential serious side effects of steroids. Remember, only your child’s doctor can decide if reducing or stopping steroids is appropriate. Like other medicines that affect your child’s immune system, REMICADE can also cause serious side effects.
In a recent, yearlong study of children with moderate to severe Crohn’s who began treatment with REMICADE, the majority of children experienced rapid symptom improvement, long-term periods of no or very few symptoms (remission), and reduction or elimination of steroid use.

Early and effective treatment is important in order to control Crohn’s disease before it has a chance to significantly affect your child’s growth and development.

Next: Assess Your Child's Symptoms

IMPORTANT SAFETY INFORMATION

Only your doctor can recommend a course of treatment after checking your health condition. REMICADE^® (infliximab) 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^®.
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. 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. For children and adults taking TNF blockers, including REMICADE^®, the chances of getting lymphoma or other cancers may increase. 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 such as histoplasmosis or coccidioidomycosis are common.
Infections that keep coming back, have diabetes or an immune system problem.
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 (such as 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 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 (such as 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 in adults and children.
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.
Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.

Medication Guide for REMICADE^®

Please read the Medication Guide for REMICADE^® and discuss it with your doctor.
(Requires Adobe^® 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: April 13, 2010