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 look yellow
movements
• little or no appetite
•fevers
•vomiting
•chills
• muscle aches
• stomach discomfort
•dark urine
•skin rash
Cancer
• People with inflammatory diseases including rheumatoid arthritis,
psoriatic arthritis, or ankylosing spondylitis, especially those with
very active disease, may be more likely to get lymphoma.
• If you use SIMPONI or other TNF blockers, your risk of getting
lymphoma or other cancers may increase.
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 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 checkyour blood counts
before and during treatment with SIMPONI.
Common side effects with SIMPONI include:
• upper respiratory tract infection
•sinus infection (sinusitis)
1
nausea
1
abnormal liver tests
1
redness at the site of injection
1
high blood pressure
1
bronchitis
1
dizziness
•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 if you have any of these symptoms:
• a rash on your cheeks or other parts ofthe body
•sensitivity to the sun
•newjointormuscle pains
• becoming verytired
• chest pain or shortness of breath
• swelling of the feet, ankles, and/or legs
• Psoriasis. Some people using TNF-blocker medicines including
SIMPONI had new psoriasis or worsening of psoriasis that
they already had. Symptoms of psoriasis include: red scaly
patches or raised bumps that are filled with pus on the skin.
Psoriasis may go away or get better after stopping SIMPONI in
some people.
• 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 effectsto 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 condition for which it was not prescribed.
• Do not give SIMPONI to other people, even ifthey have the
same condition that you have. It may harm them.
• This Medication Guide summarizes the most important
information about SIMPONI. If you would like more
information, talk to your doctor. You canaskyourdoctoror
pharmacist for information about SIMPONI that is written for
health professionals.
For more information go to www.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
Revised: April 2009
25GL09061
This Medication Guide has been approved bythe U.S. Food and
Drug Administration.
©
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■ TM
Simponi
golimumab
