REMICADE and Pediatric Crohn’s Disease

If your child has been diagnosed with moderate to severe pediatric Crohn’s disease, or if he or she is currently on medications but is still experiencing symptoms, including stomach pain, diarrhea, and weight loss or flare-ups more than two times per year, talk to his or her doctor about treatment with REMICADE.

How REMICADE works

REMICADE is an advanced treatment that works differently from conventional medications. It’s a protein that blocks a substance called TNF-alpha, which can cause inflammation in the intestines. REMICADE helps control this underlying cause of inflammation and can help get your child back to feeling better in as little as two weeks.

How REMICADE is given

REMICADE is given as an intravenous (IV) infusion by a healthcare professional, and administration takes at least two hours. The IV will be attached to your child’s arm or hand, and REMICADE will be infused directly into the bloodstream.

After the first three doses, your child will need to receive REMICADE only once every eight weeks. That could be as few as six times a year.

How REMICADE can help

In a yearlong clinical study, pediatric Crohn’s patients who began treatment with REMICADE experienced the following:

Rapid symptom improvement, or “response”
Long-term periods of no symptoms or very few symptoms, or "remission"
Reduction or elimination of steroid use

In addition, almost 9 out of 10 (88%) children experienced symptom improvement soon (Week 10) after starting treatment with REMICADE. And for most of those children, symptom relief lasted for the duration of the study – through one year.

Individual results may vary. Talk to your child’s doctor to see if REMICADE is right for your child. Please read the Medication Guide and discuss any questions or symptoms with your child’s doctor.

Talking to your child about treatment with REMICADE may not be easy. Read some useful information and tips on explaining REMICADE to your child so you can help put his or her mind at ease.

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, bremicadelood 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.

IMPORTANT SAFETY INFORMATION | Privacy Policy | Legal Notice | Site Map | About Centocor Ortho Biotech Inc.

© Centocor Ortho Biotech Inc. 1999-2009
This site is published by Centocor Ortho Biotech Inc. which is solely responsible for its contents.
It is intended for residents from the United States.
Last Updated: January 19, 2009