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?
Serious and sometimes fatal side effects have
been reported in patients taking REMICADE (see
also “What is the most important information
I should know about REMICADE?"). These
include:
Serious Infections
• Some patients have had serious infections
while receiving
REMICADE. These serious
infections include TB and infections caused
by viruses, fungi, or bacteria that have spread
throughout the body. Some patients die from
these infections. If you get an infection while
receiving treatment with REMICADE, your
doctor will treat your infection and may need
to stop your REMICADE treatment.
• Tell your doctor right away if you have any
of the following signs of an infection while
taking or after taking REMICADE:
- a fever
- have flu-like symptoms
- feel very tired
- have a cough
- warm, red, or painful skin
• Your doctor will examine you for TB and
perform a test to see if you have TB. If your
doctor feels that you are at risk for TB, you may
be treated with medicine for TB before you
begin treatment with REMICADE and during
treatment with REMICADE.
• Even if your TB test is negative, your doctor
should carefully monitor you for TB infections
while you are taking REMICADE. Patients who
had a negative TB skin test before receiving
REMICADE have developed active TB.
• If you are a chronic carrier of the hepatitis B
virus, the virus can become active while you
are being treated with REMICADE. In some
cases patients have died as a result of hepatitis
B virus being reactivated. Your doctor may do
a blood test before you start treatment with
REMICADE and occasionally while you are
being treated. Tell your doctor if you have any
of the following symptoms:
- feel unwell
- poor appetite
- tiredness (fatigue)
- fever, skin rash and/or joint pain
Cancer
• In clinical studies, more cancers were seen
in patients who took REMICADE and other
medicines that block TNF than patients who
did not receive these treatments.
• Some
patients
with
Crohn's
disease
or
ulcerative colitis who have received REMICADE
have developed a rare type of cancer called
Hepatosplenic T-cell Lymphoma. Most of these
patients were teenage or young adult males.
This type of cancer results in death. All of
these patients had also received drugs known
as azathioprine or 6-mercaptopurine together
with REMICADE.
• People who have been treated for rheumatoid
arthritis,
Crohn's
disease,
ankylosing
spondylitis,
psoriatic arthritis and
plaque
psoriasis for a long time may be more likely to
develop lymphoma. This is especially true for
people with very active disease.
• Patients with COPD (a specific type of lung
disease) may have an increased risk for getting
cancer while being treated with REMICADE.
• If you take REMICADE, your chances of getting
lymphoma or other cancers may increase.
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:
• shortness of breath
• swelling of ankles or feet
• sudden weight gain
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:
• jaundice (skin and eyes turning yellow)
• dark brown-colored urine
• fever
• pain on the right side of your stomach area
(right-sided abdominal pain)
• extreme tiredness (severe fatigue)
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:
• have a fever that does not go away
• bruise or bleed very easily
• look very pale
Nervous System Disorders
In rare cases, patients taking REMICADE have
developed problems with their nervous system. Tell
your doctor if you have:
• changes in your vision
• weakness in your arms and/or legs
• numbness or tingling in any part of your body
• seizures
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 afterwards.
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:
• hives (red, raised, itchy patches of skin)
• difficulty breathing • fever
• chest pain
• chills
• high or low blood pressure
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:
• fever
• muscle or joint pain
• rash
• difficulty swallowing
• headache
• sore throat
• swelling of the face and hands
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:
• 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
The most common side effects of
REMICADE are:
• respiratory infections, such as sinus infections
and sore throat
• headache
• coughing
• rash
• stomach pain
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), blood
in stool, 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.
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 1-800-457-6399.
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.
Product developed and manufactured by:
Centocor Ortho Biotech, Inc
200 Great Valley Parkway
Malvern, PA 19355
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Revised April 2009
25IN09401
