SIMPONP, used with the medicine methotrexate, is for adults with
moderate to severe rheumatoid arthritis (RA).
IMPORTANT SAFETY INFORMATION
SIMPONI1
(golimumab) 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 SIMPONI1
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 SIM PONI,
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 SIM PONI. 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
•skin or eyes look yellow
• little or no appetite
• vomiting
• muscle aches
• dark urine
• clay-colored bowel
movements
• fevers
• chills
• stomach discomfort
• skin rash
Heart failure can occur or get worse in people who use TNF
blockers, including 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, including SIMPONI", 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, including SIM PONI. 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, skin reaction at site
of injection, high blood pressure, flu and cold sores.
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. Call 1-800-FDA-1088
or visit www.fda.gov/medwatch.
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