MEDICATION GUIDE
Rx Only
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 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.
• Your doctor should test you for TB before
starting REMICADE.
• Your doctor should monitor you closely for
signs and symptoms of TB during treatment
with REMICADE.
Before starting REMICADE, tell your doctor
if you:
• think you have an infection. You should not
start taking REMICADE if you have any kind
of infection.
• are being treated for an infection
• have signs of an infection, such as a fever,
cough, flu-like symptoms
• have any open cuts or sores on your body
• get a lot of infections or have infections that
keep coming back
• have diabetes or an immune system problem.
People with these conditions have a higher
chance for infections.
• have TB, or if you have been in close contact
with someone with TB
• live or have lived in certain parts of the
country (such as the Ohio and Mississippi
River valleys) where there is an increased risk
for getting certain kinds of fungal infections
(histoplasmosis,
coccidioidomycosis,
or
blastomycosis). These infections may develop
or become more severe if you take REMICADE.
If you do not know if you have lived in an area
where histoplasmosis, coccidioidomycosis, or
blastomycosis is common, ask your doctor.
• have or have had hepatitis B
• use the medicine Kineret (anakinra)
After starting REMICADE, ifyou 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.
Cancer
• 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.
• Tell your doctor if you have ever had any type
of cancer. Discuss with your doctor any need to
adjust medications you may be taking.
See also, “What are the possible side effects of
REMICADE?" below.
What is REMICADE?
REMICADE is a prescription medicine that is
approved for patients with:
• Rheumatoid Arthritis-adults with moderately
to severely active rheumatoid arthritis, along
with the medicine methotrexate
• Crohn's Disease-children over the age of 6
and adults with Crohn's disease who have not
responded well enough to other medicines
• Ankylosing Spondylitis
• Psoriatic Arthritis
• Plaque Psoriasis-adult patients with plaque
psoriasis that is chronic (doesn't go away)
severe, extensive, and/or disabling
• Ulcerative Colitis-adults with moderately to
severely active ulcerative colitis who have not
responded well enough to other medicines
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:
• heart failure, unless your doctor has examined
you and decided that you are able to take
REMICADE. Talk to your doctor about your
heart failure.
• had an allergic reaction to REMICADE, or any
of the other ingredients in REMICADE. See the
end of this Medication Guide for a complete
list of ingredients in REMICADE.
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:
• have an infection (see "What is the most
important information I should know about
REMICADE?)
• have other liver problems including liver
failure
• have heart failure or other heart conditions. If
you have heart failure, it may get worse while
you take REMICADE.
• have or have had any type of cancer
• have
had
phototherapy
(treatment with
ultraviolet light or sunlight along with a
medicine to make your skin sensitive to
light) for psoriasis. You may have a higher
chance of getting skin cancer while receiving
REMICADE.
• have COPD (Chronic Obstructive Pulmonary
Disease), a specific type of lung disease.
Patients with COPD may have an increased risk
of getting cancer while taking REMICADE.
• have or have had a condition that affects your
nervous system such as
- multiple sclerosis, or Guillain-Barre syndrome,
or
- if you experience any numbness or tingling,
or
- if you have had a seizure.
• have recently received or are scheduled to
receive a vaccine. Adults
and
children
should not receive a live vaccine while
taking REMICADE. Children with Crohn's
disease should have all of their vaccines
brought up to date before starting treatment
with REMICADE.
• are pregnant or planning to become pregnant.
It is not known if REMICADE harms your
unborn baby. REMICADE should be given to a
pregnant woman only if clearly needed. Talk
to your doctor about stopping REMICADE
if you are pregnant or planning to become
pregnant.
• are breast-feeding or planning to breast-feed.
It is not known whether REMICADE passes
into your breast milk. Talk to your doctor about
the best way to feed your baby while taking
REMICADE. You should not breast-feed while
taking REMICADE.
How should I receive REMICADE?
• You will be given REMICADE through a needle
placed in a vein (IV or intravenous infusion)
in your arm.
• Your doctor may decide to give you medicine
before starting the REMICADE infusion to
prevent or lessen side effects.
• Only a healthcare professional should prepare
the medicine and administer it to you.
• REMICADE will be given to you over a period
of about 2 hours.
• If you have side effects from REMICADE, the
infusion may need to be adjusted or stopped.
In addition, your healthcare professional may
decide to treat your symptoms.
• A healthcare professional will monitor you
during the REMICADE infusion and for a
period of time afterward for side effects. Your
doctor may do certain tests while you are
taking REMICADE to monitor you for side
effects and to see how well you respond to
the treatment.
• Your doctor will determine the right dose of
REMICADE for you and how often you should
receive it. Make sure to discuss with your
doctor when you will receive infusions and to
come in for all your infusions and follow-up
appointments.
What should I avoid while receiving
REMICADE?
Do not take REMICADE and the medication KINERET
(anakinra) together.
Tell your doctor about all the medicines you
take, including prescription and non-prescription
medicines, vitamins, and herbal supplements.
