REMICADE® is a prescription medication for children
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.
REMICADE® belongs to a class of biologic medications known as tumor necrosis factor (TNF)-alpha blockers.
REMICADE® blocks a protein in your child's immune system called TNF-alpha. TNF-alpha can cause inflammation.
When your child has a chronic condition like Crohn’s disease, 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 10, nearly 9 out of 10 children (88%) achieved response with REMICADE®. |
REMISSION |
Nearly 6 out of 10 children (56%) achieved remission with REMICADE® at 1 year. |
Individual results may vary.
For pediatric moderately to severely active Crohn’s disease
REMICADE® is given as an intravenous (IV) infusion by a healthcare professional through a needle placed in a vein in your child's arm.
Given over a period of
about 2 hours
3 starter doses at
Weeks 0, 2, and 6
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.
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:
Infusion reactions can happen up to 2 hours after your child’s infusion of REMICADE®. Symptoms of infusion reactions may include:
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.
Janssen CarePath offers information on options that may be available to help you lower your out-of-pocket costs for REMICADE®.
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. Some patients, especially those 65 years and older, have had serious infections which include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body or caused infections in certain areas (such as skin). 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 tumor necrosis factor (TNF) blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in male teenagers or young men 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.
It is not known if REMICADE® is safe and effective in children under 6 years of age.
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:
Also tell your doctor if you:
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:
The more common side effects of REMICADE® include respiratory infections (such as sinus infections and sore throat), headache, coughing and stomach pain.
Please read the full Prescribing Information and Medication Guide for REMICADE® and discuss any questions you have with your doctor.
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.
cp-53017v3
REMICADE® is a prescription medication used to treat:
Crohn's Disease
Pediatric Crohn's Disease
Ulcerative Colitis
Pediatric Ulcerative Colitis
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Plaque Psoriasis
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. Some patients, especially those 65 years and older, have had serious infections which include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body or caused infections in certain areas (such as skin). 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 tumor necrosis factor (TNF) blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in male teenagers or young men 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.
It is not known if REMICADE® is safe and effective in children under 6 years of age.
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:
Also tell your doctor if you:
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:
The more common side effects of REMICADE® include respiratory infections (such as sinus infections and sore throat), headache, coughing and stomach pain.
Please read the full Prescribing Information and Medication Guide for REMICADE® and discuss any questions you have with your doctor.
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.
cp-53017v3
REMICADE® is a prescription medication used to treat:
Crohn's Disease
Pediatric Crohn's Disease
Ulcerative Colitis
Pediatric Ulcerative Colitis
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Plaque Psoriasis