Prescribing Information | Medication Guide

LEARN About REMICADE®

for adults with moderately to severely active ulcerative colitis

LEARN About REMICADE®

for adults with moderately to severely active ulcerative colitis

What is Remicade®?


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REMICADE® is a prescription medication for adults living 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 doctor to decide if REMICADE® may be right for you.



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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 immune system called TNF-alpha. TNF-alpha can cause inflammation.

  • When you have ulcerative colitis, your body produces too much TNF-alpha, a protein that helps regulate immune cells and inflammation in the body
  • Too much TNF-alpha can cause your immune system to mistakenly attack cells in the digestive tract, leading to inflammation—an underlying cause of ulcerative colitis symptoms

Proven
results

When you have a chronic condition like ulcerative colitis, it is important to talk to your doctor about treatment goals. These goals may include response (reducing symptoms), remission, and healing of the intestinal lining.

IN A 1-YEAR CLINICAL STUDY:

RESPONSE

At Week 8, nearly 7 out of 10 patients achieved response with REMICADE® compared with nearly 4 out of 10 patients not given REMICADE®.

REMISSION

Approximately 3 out of 10 patients achieved remission with REMICADE® at Week 30 compared with approximately 2 out of 10 patients not given REMICADE®.

HEALING
OF THE INTESTINAL LINING

Approximately 6 out of 10 patients experienced healing of the intestinal lining with REMICADE® at Week 8 compared with approximately 3 out of 10 patients not given REMICADE®.

Individual results may vary.


For adults with 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 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 doctor will determine the right dosage of REMICADE® for you.


Side effects
with Remicade®

What should I know about serious side effects?

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 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 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 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

Tell your doctor about any side effect that bothers you or does not go away.

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

Call your 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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