REMICADE- infliximab injection, powder, lyophilized, for solution 
Janssen Biotech, Inc.

----------

MEDICATION GUIDE
REMICADE® (Rem-eh-kaid)
(infliximab)

Read the Medication Guide that comes with REMICADE before you receive the first treatment, and before each time you get a treatment of REMICADE. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment.

What is the most important information I should know about REMICADE?

REMICADE may cause serious side effects, including:

1. Risk of infection

REMICADE is a medicine that affects your immune system. REMICADE can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving REMICADE. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections.

Before starting REMICADE, tell your doctor if you:

After starting REMICADE, if you have an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. REMICADE can make you more likely to get infections or make any infection that you have worse.

2. Risk of Cancer

See the section "What are the possible side effects of REMICADE?" below for more information.

What is REMICADE?

REMICADE is a prescription medicine that is approved for patients with:

REMICADE blocks the action of a protein in your body called tumor necrosis factor-alpha (TNF-alpha). TNF-alpha is made by your body's immune system. People with certain diseases have too much TNF-alpha that can cause the immune system to attack normal healthy parts of the body. REMICADE can block the damage caused by too much TNF-alpha.

Who should not receive REMICADE?

You should not receive REMICADE if you have:

What should I tell my doctor before starting treatment with REMICADE?

Your doctor will assess your health before each treatment.

Tell your doctor about all of your medical conditions, including if you:

If you have a baby and you were using REMICADE during your pregnancy, it is important to tell your baby's doctor and other health care professionals about your REMICADE use so they can decide when your baby should receive any vaccine. Certain vaccinations may cause infections.

If you received REMICADE while you were pregnant, your baby may be at higher risk for getting an infection for at least six months after the last dose of REMICADE you received during your pregnancy.

How should I receive REMICADE?

What should I avoid while receiving REMICADE?

Do not take REMICADE together with medications such as KINERET (anakinra), ORENCIA (abatacept), ACTEMRA (tocilizumab), or other medicines called biologics that are used to treat the same conditions as REMICADE.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. These include any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis.

Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine.

What are the possible side effects of REMICADE?

REMICADE can cause serious side effects, including:

See "What is the most important information I should know about REMICADE?".

Serious Infections

Heart Failure

If you have a heart problem called congestive heart failure, your doctor should check you closely while you are taking REMICADE. Your congestive heart failure may get worse while you are taking REMICADE. Be sure to tell your doctor of any new or worse symptoms including:

Treatment with REMICADE may need to be stopped if you get new or worse congestive heart failure.

Liver Injury

In rare cases, some patients taking REMICADE have developed serious liver problems. Tell your doctor if you have

Blood Problems

In some patients taking REMICADE, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you

Nervous System Disorders

In rare cases, patients taking REMICADE have developed problems with their nervous system. Tell your doctor if you have

Allergic Reactions

Some patients have had allergic reactions to REMICADE. Some of these reactions were severe. These reactions can happen while you are getting your REMICADE treatment or shortly afterward. Your doctor may need to stop or pause your treatment with REMICADE and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include:

Some patients treated with REMICADE have had delayed allergic reactions. The delayed reactions occurred 3 to 12 days after receiving treatment with REMICADE. Tell your doctor right away if you have any of these signs of delayed allergic reaction to REMICADE:

Lupus-like Syndrome

Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with REMICADE.

Psoriasis

Some people using REMICADE had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with REMICADE.

The most common side effects of REMICADE include:

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

Children who took REMICADE in studies for Crohn's disease showed some differences in side effects compared with adults who took 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 took REMICADE for ulcerative colitis in clinical studies, more children had infections as compared with adults.

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.

General information about REMICADE

Medicines are sometimes prescribed for purposes that are not mentioned in Medication Guides or patient information sheets. Do not use REMICADE for a condition for which it was not prescribed.

This information sheet summarizes the most important information about REMICADE. You can ask your doctor or pharmacist for information about REMICADE that is written for health professionals.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For more information go to www.remicade.com, or call 1-800-JANSSEN (1-800-526-7736).

What are the ingredients in REMICADE?

The active ingredient is Infliximab.

The inactive ingredients in REMICADE include: sucrose, polysorbate 80, monobasic sodium phosphate monohydrate, and dibasic sodium phosphate dihydrate. No preservatives are present.

Manufactured by:
Janssen Biotech, Inc.
Horsham, PA 19044

U.S. License No. 1864

Revised November 2013

©Janssen Biotech, Inc. 2013

This Medication Guide has been approved by the U.S. Food and Drug Administration

Revised: 11/2013
 
Janssen Biotech, Inc.