IMPORTANT SAFETY INFORMATION
How will my doctor decide if REMICADE®
is right for me?
Only your doctor can recommend a course of treatm ent,
after checking your health condition. Your doctor should
discuss w ith you any potential benefits and risks and help
you make the best treatm ent decision. W hile REMICADE®
may help you feel better, like other medicines th a t affect
your immune system, it can cause serious side effects, such
as low ering your ability to fig h t infections. There are
reports o f serious infections caused by viruses, fungi or
bacteria th a t have spread throughout the body, including
tuberculosis (TB) and histoplasmosis. Some o f these
infections have been fatal. Your doctor should m onitor
you closely fo r signs and symptoms o f TB during
treatm ent w ith REMICADE® You should discuss any
concerns about your health and medical care w ith
your doctor.
W hat should I tell my doctor before I
take REMICADE®?
You should let your doctor know if you have or ever had
any o f the follow ing:
• Tuberculosis (TB) or have been near someone w ho has
TB. Your doctor w ill check you fo r TB w ith a skin test.
If you have latent (inactive) TB, you w ill begin TB
treatm ent before you start REMICADE.®
• Lived in a region where certain fungal infections like
histoplasmosis or coccidioidomycosis are common.
• An infection th a t keeps coming back (or any problems
th a t increase the risk o f infection) or have diabetes.
• Any type o f cancer or a risk factor fo r developing cancer,
fo r example, chronic obstructive pulm onary disease
(COPD) or had phototherapy fo r psoriasis.
• Heart failure or any heart condition. Many people w ith
heart failure should not take REMICADE.®
• Hepatitis B virus (HBV) infection, or th in k you may be a
carrier o f HBV.
• Nervous system disorders (like m ultiple sclerosis or
Guillain-Barre syndrome).
Also tell your doctor about any medications you are
taking, including vaccines or Kineret (anakinra), and if
you are pregnant, plan to become pregnant or are
nursing. Adults and children should not receive a live
vaccine w hile taking REMICADE®
W hat should I watch for and talk to my doctor
about before or while taking REMICADE®?
The follow ing serious (sometimes fatal) side effects
have been reported in people taking REMICADE.®
You should tell your doctor right away if you have any
o f 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 th a t you have
worse.
• Lymphoma, including a rare form of often fatal lymphoma
th a t has occurred in young people w ith Crohn's disease
w h o w ere taking azathioprine or 6-mercaptopurine,
or any other cancers.
• Heart failure— new or worsening symptoms, such as
shortness o f breath, swelling o f your ankles or feet,
or sudden w eight gain.
• Reactivation o f HBV— feeling unwell, poor appetite,
tiredness, fever, skin rash, and/or jo in t pain.
• Liver injury— jaundice (yellow skin and eyes), dark
brown urine, right-sided abdominal pain, fever,
or severe tiredness.
• Blood disorders— fever th a t doesn't go away, bruising,
bleeding, or severe paleness.
• Nervous system disorders— numbness, weakness,
tingling, changes in your vision, or seizures.
• Allergic reactions during or after the infusion— hives,
difficulty breathing, chest pain, high or low blood
pressure, swelling o f face and hands, and fever or chills.
• Lupus-like syndrome— chest discom fort or pain that
does not go away, shortness o f breath, jo in t pain, rash
on the cheeks or arms th a t gets worse in the sun.
The more com m on side effects w ith REMICADE® are
respiratory infections (th a t may include sinus infections
and sore th ro a t), headache, rash, coughing, and
stomach pain.
Please read the Medication Guide fo r REMICADE® on the
follow ing pages and discuss it w ith your rheum atologist.
You are encouraged to report negative side effects o f
prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call
1
-
800
-FDA-
1088
.
To receive a free DVD with information that can help you to talk to your
rheumatologist—call 1-866-405-1944 or visit www.Remicade.com
accessone’
Do you have any questions about insurance coverage
or payment assistance for REMICADE® treatment?
Call AccessOne® at 1-888-ACCESS-1 (222-3771).
R em icad e
INFLIXIMAB
