Prescribing Information | Medication Guide

LEARN About REMICADE®

for pediatric moderately to severely active Crohn's disease

LEARN About REMICADE®

for pediatric moderately to severely active Crohn's disease

What is Remicade®?


REMICADE® is a prescription medication for children 6 years of age and older with moderately to severely active Crohn’s disease 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.



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 Crohn’s disease 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 Crohn’s disease symptoms

Proven
results

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

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.

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 dose 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. 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



IMPORTANT SAFETY INFORMATION
WHAT IS REMICADE®?
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. 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. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death.
  • 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.
  • Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
  • Lymphoma, or any other cancers in adults and children.
  • Skin cancer—any changes in or growths on your skin.
  • Cervical cancer—your doctor may recommend that you be regularly screened. Some women with rheumatoid arthritis, particularly those over 60, have developed cervical cancer.
  • Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
  • Other heart problems within 24 hours of infusion, including heart attack, low blood flow to the heart, or abnormal heart rhythm—chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat.
  • 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.
  • Stroke within 24 hours of infusion—numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking; dizziness; loss of balance or coordination; or a sudden, severe headache.
  • Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, and fever or chills.
  • Delayed allergic reactions (3 to 12 days after infusion)—fever, rash, headache, sore throat, muscle or joint pain, swelling of the face and hands, or difficulty swallowing.
  • 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 most common side effects of REMICADE® include respiratory infections (that may include sinus infections and sore throat), headache, rash, 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-53017v1




WHAT IS REMICADE®?

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

Pediatric Crohn's Disease

  • 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

Ulcerative Colitis

  • 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

Pediatric Ulcerative Colitis

  • 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

Rheumatoid Arthritis

  • 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

Psoriatic Arthritis

  • Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis

Ankylosing Spondylitis

  • Can reduce signs and symptoms in patients with active ankylosing spondylitis

Plaque Psoriasis

  • 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



IMPORTANT SAFETY INFORMATION
WHAT IS REMICADE®?
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. 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. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death.
  • 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.
  • Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
  • Lymphoma, or any other cancers in adults and children.
  • Skin cancer—any changes in or growths on your skin.
  • Cervical cancer—your doctor may recommend that you be regularly screened. Some women with rheumatoid arthritis, particularly those over 60, have developed cervical cancer.
  • Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
  • Other heart problems within 24 hours of infusion, including heart attack, low blood flow to the heart, or abnormal heart rhythm—chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat.
  • 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.
  • Stroke within 24 hours of infusion—numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking; dizziness; loss of balance or coordination; or a sudden, severe headache.
  • Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, and fever or chills.
  • Delayed allergic reactions (3 to 12 days after infusion)—fever, rash, headache, sore throat, muscle or joint pain, swelling of the face and hands, or difficulty swallowing.
  • 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 most common side effects of REMICADE® include respiratory infections (that may include sinus infections and sore throat), headache, rash, 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-53017v1




WHAT IS REMICADE®?

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

Pediatric Crohn's Disease

  • 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

Ulcerative Colitis

  • 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

Pediatric Ulcerative Colitis

  • 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

Rheumatoid Arthritis

  • 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

Psoriatic Arthritis

  • Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis

Ankylosing Spondylitis

  • Can reduce signs and symptoms in patients with active ankylosing spondylitis

Plaque Psoriasis

  • 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