SiM PONi,™ taken w ith the medicine methotrexate, is approved to treat adults w ith moderate
to severe rheumatoid arthritis (RA).
IMPORTANT SAFETY INFORMATION
SiMPONi™ is a prescription medicine. SIMPONI™ can
lower your ability to fight infections. There are reports of
serious infections caused by bacteria, fungi, or viruses that
have spread throughout the body, including tuberculosis
(TB) and histoplasmosis. Some of these infections have
been fatal. Your doctor will test you for TB before starting
SIMPONI™ and will 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 Mississippi River Valleys
and the Southwest) where certain fungal infections like
histoplasmosis or coccidioidomycosis 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
Tell your doctor about all the medications you take including
ORENCIA (abatacept), KINERET (anakinra) and 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:
1
feel very tired
1
skin or eyes look yellow
1
little or no appetite
■vomiting
1
muscle aches
1
dark urine
' clay-colored bowel
movements
' fevers
' chills
' stomach discomfort
' skin rash
If you take SIMPONI™ or other TNF blockers, your risk for
developing lymphoma or other cancers may increase. You should
tell your doctor if you have had or develop lymphoma or other
cancers. Heart failure can occur or get worse in people who use
TNF blockers like SIMPONI™
©2009 Centocor Ortho Biotech inc.
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Your doctor will closely monitor you if you have heart failure.
Tell your doctor right aw ay 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. Symptoms
include: red scaly patches or raised bumps that are filled with
pus on the skin. These symptoms may go away or get better
after stopping SIMPONI™
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™
on the following pages, and discuss any questions
you have with your doctor.
You are encouraged to report negative side
effects of prescription drugs to the FDA.
Visit ww w .fda.gov/m edw atch, or call
1-800-FDA-1088.
monthly
©
•
• TM
Sim poni
golimumab
Just one dose, once a month.
