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.
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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:
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feel very tired
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clay-colored bowel
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skin or eyes look yellow
movements
•little or no appetite
«fevers
•vomiting
«chills
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muscle aches
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stomach discomfort
•dark urine
«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.
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If you have heart failure, your condition should be watched
closely while you take SIMPONI.
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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.
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Tell your doctor right away if you get any of these symptoms:
•vision changes
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weakness in your arms or legs
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numbness or tingling in any part of your 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 look yellow
•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 check your blood counts
before and during treatment with SIMPONI.
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becoming very tired
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chest pain or shortness of breath
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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
if you develop red scaly patches or raised bumps that 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 of an allergic reaction:
•hives
•swollen face
•breathing trouble
•chest pain
These are not all of the side effects with SIMPONI. Tell your
doctor about any side effect that bothers you or does not go
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 SIM P O N I?
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Refrigerate SIMPONI at 36°F to 46°F (2°C to 8°C).
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Do not freeze SIMPONI.
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Keep SIMPONI in the carton to protect it from light when
not being used.
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Do not shake SIMPONI.
Keep SIM P O N I and all medicines out of the reach of children.
General Information about SIM P O N I
Medicines are sometimes prescribed for purposes other than
those listed in the Medication Guide. Do not use SIMPONI for
a condition for which it was not prescribed.
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Do not give SIMPONI to other people, even if they have the
same condition that you have. It may harm them.
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This Medication Guide summarizes the most important
information about SIMPONI. If you would like more
information, talk to your doctor. You can ask your doctor or
pharmacist for information about SIMPONI that is written for
health professionals. For more information go to www.simponi.com
or call 1-800-457-6399.
W hat are the ingredients in SIM P O N I?
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:
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upper respiratory tract infection
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nausea
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abnormal liver tests
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redness at the site of injection
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high blood pressure
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bronchitis
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dizziness
•sinus infection (sinusitis)
•flu
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runny nose
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fever
•cold sores
•numbness or tingling
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 if you have any of these symptoms:
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a rash on your cheeks or other parts of the body
•sensitivity to the sun
•
new joint or muscle pains
Revised: 11/2009
25GL09421
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
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TM
Simponi
golimumab
