What are the possible side effects with SIMPONI?
SIMPONI can cause serious side effects, including:
See
"What is the most important information I should know
about SIMPONI?".
Serious Infections
Hepatitis B infection in people who carry the virus in their blood.
•
If you are a carrier of the hepatitis B virus (a virus that affects
the liver), the virus can become active while you use SIMPONI.
Your doctor may do blood tests before you start treatment with
SIMPONI and while you are using SIMPONI. Tell your doctor if
you have any of the following symptoms of a possible hepatitis
B infection:
•feel very tired
•
clay-colored bowel
•skin or eyes lookyellow
movements
•
little or no appetite
•
fevers
•vomiting
•chills
•muscle aches
•
stomach discomfort
•darkurine
•skin rash
Heart failure, including new heart failure or worsening of heart
failure that you already have.
New or worse heart failure can
happen in people who use TNF-blocker medicines like SIMPONI.
•
If you have heart failure, your condition should be watched
closely while you take SIMPONI.
•
Call your doctor right away if you get new or worsening symptoms
of heart failure while taking SIMPONI (such as shortness of breath
or swelling of your lower legs or feet).
Nervous System Problems
Rarely, people using TNF-blocker medicine have nervous system
problems such as multiple sclerosis.
•
Tell your doctor right away if you get any of these symptoms:
•vision changes
•
weakness in your arms or legs
•
numbness ortingling in any partofyour body
Liver Problems
Liver problems can happen in people who use TNF-blocker
medicines, including SIMPONI. These problems can lead to liver
failure and death. Call your doctor right away if you have any of
these symptoms:
•feel very tired
•skin or eyes lookyellow
•
poor appetite or vomiting
•
pain on the right side of your stomach (abdomen)
Blood Problems
Low blood counts have been seen with other TNF blockers. Your
body may not make enough blood cells that help fight infections or
help stop bleeding. Symptoms include fever, bruising or bleeding
easily, or looking pale. Your doctor will checkyour blood counts
before and during treatment with SIMPONI.
•
becoming verytired
•
chest pain or shortness of breath
•
swelling of the feet, ankles, and/or legs
•
Psoriasis.
Some people using SIMPONI had new psoriasis or
worsening of psoriasis that they already had. Tell your doctor
ifyou develop red scaly patches or raised bumpsthat are filled
with pus. Your doctor may decide to stop your treatment with
SIMPONI.
•
Allergic Reactions.
Allergic reactions can happen in people
who use TNF-blocker medicines. Call your doctor right away if
you have any of these symptoms ofanallergic reaction:
•
hives
•
swollen face
•
breathing trouble
•
chest pain
These are not all ofthe side effectswith SIMPONI. Tell your
doctor about any side effect that bothers you or does notgo
away. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088.
How do I store SIMPONI?
•
Refrigerate SIMPONI at36°Fto 46°F(2°Cto 8°C).
•
Do notfreeze SIMPONI.
•
Keep SIMPONI in the carton to protect itfrom lightwhen
not being used.
•
Do not shake SIMPONI.
Keep SIMPONI and all medicines out of the reach of children.
General Information about SIMPONI
Medicines are sometimes prescribed for purposes other than
those listed in the Medication Guide. Do not use SIMPONI for
a conditionforwhich itw as notprescribed.
•
Do not give SIMPONI to other people, even ifthey have the
same condition thatyou have. It may harm them.
•
This Medication Guide summarizes the most important
information about SIMPONI. Ifyou would like more
information, talktoyour doctor. Youcan ask your doctor or
pharmacistfor information about SIMPONI that is written for
health professionals. For more information gotowww.simponi.com
orcall 1-800-457-6399.
What are the ingredients in SIMPONI?
Active ingredient: golimumab.
Inactive ingredients: L-histidine, L-histidine monohydrochloride
monohydrate, sorbitol, polysorbate 80, and water for injection.
SIMPONI does not contain preservatives.
Manufactured by:
Centocor Ortho Biotech Inc.
Horsham, PA 19044
US License No. 1821
Common side effects with SIMPONI include:
1
upper respiratory tract infection
1
nausea
1
abnormal liver tests
1
redness at the site of injection
1
high blood pressure
1
bronchitis
1
dizziness
•sinus infection (sinusitis)
•
flu
•
runny nose
•fever
•
cold sores
•
numbness ortingling
Other side effects with SIMPONI include:
• Immune System Problems.
Rarely, people using TNF-blocker
medicines have developed symptoms that are like the symptoms
of lupus. Tell your doctor ifyou have any of these symptoms:
•
a rash onyourcheeksorother parts of the body
•
sensitivity to the sun
•
newjoint or muscle pains
Revised: 11/2009
25GL09421
This Medication Guide has been approved bythe U.S. Food and
Drug Administration.
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• TM
S im p o n i
golimumab
