SIMPONI,™ taken w ith th e m edicine m eth o tre x ate , is approved to tre a t adults w ith
m o d erate to severe rheu m ato id a rth ritis (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 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 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:
• 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
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.“
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. 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
follow ing 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
www.fda.gov/medwatch, or call 1-800-FDA-1088.
*
monthly
S i m p o m ”
golimumab
©2009
Centocor Ortho
Biotech Inc.
11/09
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