Prescribing Information | Medication Guide

LEARN About REMICADE®

for pediatric moderately to severely active ulcerative colitis

LEARN About REMICADE®

for pediatric moderately to severely active ulcerative colitis

What is Remicade®?


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REMICADE® is a prescription medication for children 6 years of age and older with moderately to severely active ulcerative colitis who haven’t responded well to other medicines.

REMICADE® is not right for everyone, and individual results may vary. Talk with your child's doctor to decide if REMICADE® may be right for your child.



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REMICADE® belongs to a class of biologic medications known as tumor necrosis factor (TNF)-alpha blockers.

How does
Remicade® work?

REMICADE® blocks a protein in your child's immune system called TNF-alpha. TNF-alpha can cause inflammation.

  • Children with ulcerative colitis produce too much TNF-alpha, a protein that helps regulate immune cells and inflammation in the body
  • Too much TNF-alpha can cause your child’s immune system to mistakenly attack cells in the digestive tract, leading to inflammation—an underlying cause of pediatric ulcerative colitis symptoms

Proven
results

When your child has a chronic condition like ulcerative colitis, it is important to talk to his or her doctor about treatment goals. These goals may include response (reducing symptoms) and remission.

IN A 1-YEAR CLINICAL STUDY:

RESPONSE

At Week 8, more than 7 out of 10 children (73%) achieved response with REMICADE®.

REMISSION

Nearly 4 out of 10 children (38%) achieved remission with REMICADE® at 1 year.

Individual results may vary.


For pediatric moderately to severely active ulcerative colitis

Dosing with Remicade®

INFUSIONS EVERY 8 WEEKS AFTER 3 STARTER DOSES

REMICADE® is given as an intravenous (IV) infusion by a healthcare professional through a needle placed in a vein in your child's arm.

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Given over a period of
about 2 hours

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3 starter doses at
Weeks 0, 2, and 6

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After starter doses, 1 maintenance
dose is infused every 8 weeks


Your child's doctor will determine the right dosage of REMICADE® for your child.


Side effects
with Remicade®

What should I know about serious side effects?

REMICADE® can lower your child’s ability to fight infections. Serious and sometimes fatal events can occur. There have been reports of serious infections, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that have spread throughout the body or cause infections in certain areas. Lymphoma, including a fatal kind called hepatosplenic T-cell lymphoma, and other cancers have been reported in children and adults taking REMICADE®. Some people with heart failure should not take REMICADE®. Other serious side effects reported include skin cancer, cervical cancer, hepatitis B, heart problems or stroke within 24 hours of infusion, liver injury, blood problems, nervous system problems, allergic reactions, or lupus-like syndrome. To learn more about these and other risks, please read the Important Safety Information and the Medication Guide and discuss any questions you have with your child's doctor.

What are the common side effects?

The most common side effects of REMICADE® include:

  • respiratory infections, such as sinus infections and sore throat
  • headache
  • coughing
  • stomach pain

Infusion reactions can happen up to 2 hours after your child’s infusion of REMICADE®. Symptoms of infusion reactions may include:

  • fever
  • chills
  • chest pain
  • low blood pressure or high blood pressure
  • shortness of breath
  • rash
  • itching

Children who received REMICADE® in studies for Crohn’s disease showed some differences in side effects compared with adults who received REMICADE® for Crohn’s disease. The side effects that happened more in children were anemia (low red blood cells), leukopenia (low white blood cells), flushing (redness or blushing), viral infections, neutropenia (low neutrophils, the white blood cells that fight infection), bone fracture, bacterial infection and allergic reactions of the breathing tract. Among patients who received REMICADE® for ulcerative colitis in clinical studies, more children had infections as compared with adults.

Tell your child’s doctor about any side effect that bothers your child or does not go away.

These are not all of the side effects with REMICADE®. Ask your child’s doctor or pharmacist for more information.

Call your child’s doctor for medical advice about side effects.


Paying for Remicade®

Janssen CarePath offers information on options that may be available to help you lower your out-of-pocket costs for REMICADE®.


LEARN ABOUT COST SUPPORT OPTIONS



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