How REMICADE® Works
A child’s immune system works around the clock to protect against bacteria, viruses, and other foreign agents. When your child has pediatric ulcerative colitis (PUC), the immune system becomes overactive and produces excess amounts of a protein called tumor necrosis factor-alpha, or TNF-alpha.
The presence of excess TNF-alpha causes a child’s immune system to attack healthy cells in the gastrointestinal tract. This leads to the inflammation children experience as the symptoms of PUC. REMICADE® has been shown to block the action of TNF-alpha. This inhibits the underlying causes of inflammation.
See how REMICADE® works in the illustration below:
REMICADE® is not for everyone
REMICADE® is a strong medication that can cause serious side effects. Only your child’s doctor can decide if REMICADE® is right for your child.
REMICADE® can lower your 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. 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, hepatitis B, liver injury, blood problems, allergic reactions, nervous system problems, or lupus-like syndrome. To learn more about these and other risks, please read the Important Safety Information and the Medication Guide, and talk with your doctor.
REMICADE® is given by IV infusion
If your doctor decides REMICADE® is right for your child, he or she will receive it as an intravenous (IV) infusion from a healthcare professional over a 2-hour period. REMICADE® is the only medication of its kind to require as few as 6 treatments a year after 3 starter doses. That’s once every 8 weeks.
REMICADE® is given either in your doctor’s office or in a treatment center, so someone will always be close by while your child receives treatment and for a period of time afterward to monitor him or her for side effects. And because REMICADE® is infused, it goes directly into your child’s bloodstream and gets right to work. Plus, REMICADE® is nonsedating, so your child should be able to resume his or her daily activities, as advised by your doctor.
Customized dosing based on body weight
Before each infusion, your doctor will calculate the right amount of medication for your child, based on body weight.
How should my child receive REMICADE®?
- Your child will be given REMICADE® through a needle placed in a vein (IV, or intravenous infusion) in his or her arm
- The doctor may decide to give your child medication before starting the REMICADE® infusion, to prevent or lessen side effects
- Only a healthcare professional should prepare the medication and administer it to your child
- REMICADE® will be given to your child over a period of at least 2 hours
- If your child has side effects from REMICADE®, the infusion may need to be adjusted or stopped. In addition, your child’s healthcare professional may decide to treat your child’s symptoms
- A healthcare professional will monitor your child during the REMICADE® infusion and for a period of time afterward for side effects. The doctor may do certain tests while your child is taking REMICADE® to monitor him or her for side effects and to see how well your child responds to the treatment
- Your doctor will determine the right dose of REMICADE® for your child and how often he or she should receive it
- Make sure to discuss with the doctor when your child will receive infusions and be sure to come in for all of your child’s infusions and follow-up appointments
REMICADE® is a prescription medication used to treat:Crohn's Disease
- Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven't responded well to other therapies
- Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active Crohn's disease who haven't responded well to other therapies
- Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven't responded well to other therapies
- Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active ulcerative colitis who haven’t responded well to other therapies
- Can reduce signs and symptoms, help stop further joint damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate
- Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis
- Can reduce signs and symptoms in patients with active ankylosing spondylitis
- 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
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 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. Hepatosplenic T-cell lymphoma, 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 like 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. Your doctor will test you for HBV.
- Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).
Also tell your doctor if you:
- Use the medicines Kineret (anakinra), Orencia (abatacept) or Actemra (tocilizumab) or other medicines called biologics used to treat the same problems as REMICADE®.
- Are pregnant, plan to become pregnant, are breast-feeding, or have a baby and were using REMICADE® during your pregnancy. Tell your baby’s doctor about your REMICADE® use before the baby receives any vaccine because of an increased risk of infection for up to 6 months after your last dose of REMICADE® you received during your pregnancy.
- Recently received or are scheduled to receive a vaccine. Adults and children taking REMICADE® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer) 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 in adults and children.
- Skin cancer—any changes in or growths on your skin.
- 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.
- Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.
The more common side effects with REMICADE® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
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.