SIMPONI,™ taken with the medicine methotrexate, is approved to treat adults with
moderate to severe rheumatoid arthritis (RA).
S IM P O N I™ (golim um ab) is a
IM PO RTA N T
prescription medicine. SIMPONI™
S A FE T Y
can low er your ability to fight
INFO RM ATIO N
infections. There are reports of
serio u s in fectio n s cau sed by
bacteria, fungi, or viruses that
have spread throughout the body, including tuberculosis
(TB) and histoplasm osis. Some of these infections
have been fatal. Your doctor will test you for TB before
starting SIMPONI™ and w ill monitor you for signs of
TB during treatment. Tell your doctor if you have been
in close contact with people with TB. Tell your doctor
if you have been in a region (such as the Ohio and
M ississippi River Valleys and the Southwest) where
certain fungal infections like h isto p lasm o sis or
coccidioidom ycosis are common.
You should not start SIMPONI“ if you have any kind of infection.
Tell your doctor if you are prone to or have a history of infections
or have diabetes, HIV or a weak immune system. You should also
tell your doctor if you are currently being treated for an infection
or if you have or develop any signs of an infection such as:
• fever, sweat, or chills
• muscle aches
• cough
• shortness of breath
•blood in phlegm
• weight loss
•warm, red, or painful skin
or sores on your body
•diarrhea or stomach pain
•burning when you urinate
or urinate more than normal
•feel very tired
Unusual cancers have been reported in children and
teenage patients taking TNF-blocker medicines.
For
children and adults taking TNF blockers, including SIMPONI“
the chances for getting lymphoma or other cancers may
increase. You should tell your doctor if you have had or develop
lymphoma or other cancers.
Tell your doctor about all the medications you take including
ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab)
or another TNF blocker, or if you are scheduled to or recently
received a vaccine. People taking SIMPONI“ should not receive
live vaccines.
Reactivation of hepatitis B virus has been reported in patients
who are carriers of this virus and are taking TNF-blocker
medicines, such as SIMPONI“ Some of these cases have been
fatal. Your doctor may do blood tests before and after you start
treatment with SIMPONI“ Tell your doctor if you know or think
you may be a carrier of hepatitis B virus or if you experience
signs of hepatitis B infection, such as:
• feel very tired
• clay-colored bowel
• skin or eyes look yellow
movements
• little or no appetite
»fevers
•vomiting
«chills
• muscle aches
* stomach discomfort
• dark urine
• skin rash
Heart failure can occur or get worse in people who use TNF
blockers like SIMPONI“ Your doctor will closely monitor you
if you have heart failure. Tell your doctor right away if you get
new or worsening symptoms of heart failure like shortness of
breath or swelling of your lower legs or feet.
Rarely, people using TNF blockers can have nervous system
problems such as multiple sclerosis. Tell your doctor right away if
you have symptoms like vision changes, weakness in your arms
or legs, or numbness or tingling in any part of your body.
Liver problems can happen in people using TNF blockers.
Contact your doctor immediately if you develop symptoms such
as feeling very tired, skin or eyes look yellow, poor appetite or
vomiting, or pain on the right side of your stomach.
Low blood counts have been seen with people using TNF
blockers. If this occurs, your body may not make enough blood
cells to help fight infections or help stop bleeding. Your doctor
will check your blood counts before and during treatment. Tell
your doctor if you have signs such as fever, bruising, bleeding
easily, or paleness.
Rarely, people using TNF blockers have developed lupus-like
symptoms. Tell your doctor if you have any symptoms such as a
rash on your cheeks or other parts of the body, sensitivity to the
sun, new joint or muscle pain, becoming very tired, chest pain or
shortness of breath, swelling of the feet, ankles, and/or legs.
New or worse psoriasis symptoms may occur. Tell your doctor
if you develop red scaly patches or raised bumps that are
filled with pus.
Tell your doctor if you are allergic to rubber or latex. The needle
cover contains dry natural rubber.
Tell your doctor if you have any symptoms of an allergic reaction
while taking SIMPONI“ such as hives, swollen face, breathing
trouble, chest pain.
Common side effects of SIMPONI“ include: upper respiratory
tract infection, nausea, abnormal liver tests, redness at site of
injection, high blood pressure, bronchitis, dizziness, sinus infection,
flu, runny nose, fever, cold sores, numbness, or tingling.
Please read the Medication Guide for SIMPONI™ and
discuss any questions you have with your doctor.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
©2009
Centocor Ortho Biotech Inc.
12/09
25
GL
09446
Just one dose, once a month.
25
GL
09424
