Medication Guide
Rx Only
MEDICATION GUIDE
SIMPONI™ (SIM-po-nee)
(golimumab)
Read the Medication Guide that comes with SIMPONI before you
start taking it and each time you get a refill. There may be new
information. This Medication Guide does not take the place of talking
with your doctor about your medical condition or treatment. It is
important to remain under your doctor's care while using SIMPONI.
What is the most important information I should know
about SIMPONI?
SIMPONI is a medicine that affects your immune system. SIMPONI
can lower the ability of your immune system to fight infections.
Some people have serious infections while taking SIMPONI,
including tuberculosis (TB), and infections caused
by bacteria, fungi, or viruses that spread throughout their body.
Some people have died from these serious infections.
• Your doctor should test you for TB before starting SIMPONI.
• Your doctor should monitor you closely for signs and
symptoms of TB during treatment with SIMPONI.
You should not start taking SIMPONI if you have any kind of
infection unless your doctor says it is okay.
Before starting SIMPONI, tell your doctor if you:
• think you have an infection or have symptoms 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 often than normal
'feel very tired
' are being treated for an infection
■
get a lot of infections or have infections that keep coming back
' have diabetes, HIV, or a weak immune system.
People with these conditions have a higher chance for infections.
' have TB, or have been in close contact with someone with TB
' live, have lived, or traveled to certain parts of the country (such as
the Ohio and Mississippi River valleys and the Southwest) where
there is an increased chance for getting certain kinds of fungal
infections (histoplasmosis, coccidioidomycosis, blastomycosis).
These infections may happen or become more severe if you use
SIMPONI. Ask your doctor, if you do not know if you have lived in
an area where these infections are common.
' have or have had hepatitis B
' use the medicine Orencia (abatacept), Kineret (anakinra),
or Rituxan (rituximab)
After starting SIMPONI, call your doctor right away if you have any
symptoms of an infection. SIMPONI can make you more likely to get
infections or make worse any infection that you have.
What is SIMPONI?
SIMPONI is a prescription medicine called a Tumor Necrosis Factor
(TNF) blocker. SIMPONI is used in adults:
• with the medicine methotrexate to treat moderately to
severely active rheumatoid arthritis (RA)
•to treat active psoriatic arthritis (PsA) alone or with methotrexate
•ltoltreatlactivelankylosinglspondylitisl(AS)
Youlmaylcontinueltoluselotherlmedicineslthatlhelpltreatlyourl
condition while taking SIMPONI, such as non- steroidal
anti-inflammatory drugs (NSAIDs) and prescription steroids,
as recommended by your doctor.
What should I tell my doctor before starting treatment
with SIMPONI?
SIMPONI may not be right for you. Before starting SIMPONI,
tell your doctor about all your medical conditions, including if you:
• have an infection (see "What is the most important information
I should know about SIMPONI?").
• have or have had lymphoma or any other type of cancer.
• have or had heart failure.
• have or have had a condition that affects your nervous system,
such as multiple sclerosis.
• have recently received or are scheduled to receive a vaccine.
People taking SIMPONI should not receive live vaccines. People
taking SIMPONI can receive non-live vaccines.
• are allergic to rubber or latex. The needle cover on the prefilled
syringe and SmartJect autoinjector contains dry natural rubber.
• are pregnant or planning to become pregnant. It is not known if
SIMPONI will harm your unborn baby.
• are breastfeeding. You and your doctor should decide if you
will take SIMPONI or breastfeed. You should not do both
without talking to your doctor first.
Tell your doctor about all the medicines you take, including
prescription and non-prescription medicines, vitamins, and herbal
supplements. Especially, tell your doctor if you use:
•ORENCIA (abatacept), KINERET (anakinra), or RITUXAN
(rituximab).lYoulshouldlnotltakelSIMPONIlwhilelyoularelalsol
takinglORENCIAlorlKINERET.lYourldoctorlmaylnotlwantltolgivel
you SIMPONI if you have received RITUXAN recently.
• Another TNF-blocker medicine. You should nottake SIMPONI while you
are also taking REMICADE (infliximab), HUMIRA (adalimumab),
ENBREL (etanercept), or CIMZIA (certolizumab pegol).
Ask your doctor if you are not sure if your medicine is one listed above.
Keeplallistloflalllyourlmedicationslwithlyoultolshowlyourldoctorlandl
pharmacist each time you get a new medicine.
How should I use SIMPONI?
• SIMPONI is given as an injection underthe skin (subcutaneous
injection or SC).
• SIMPONI should be injected one time each month.
• If your doctor decides that you or a caregiver may be able to give
your injections of SIMPONI at home, you should receive training
on the right way to prepare and inject SIMPONI. Do not try to
inject SIMPONI yourself until you have been shown the right way
to give the injections by your doctor or nurse.
• Use SIMPONI exactly as prescribed by your doctor.
• SIMPONI comes in a prefilled syringe or SmartJect™ autoinjector.
Your doctor will prescribe the type that is best for you.
• Seethe detailed Patient Instructions for Use at the end of this
Medication Guide for instructions about the right way to prepare
and give your SIMPONI injections at home.
• Do notmiss any doses of SIMPONI. Ifyou forget to use SIMPONI,
inject your dose as soon as you remember. Then, take your next
dose at your regular scheduled time. In case you are not sure
when to inject SIMPONI, call your doctor or pharmacist.
What are the possible side effects with SIMPONI?
SIMPONI can cause serious side effects including:
Serious Infections
(See "What is the most important information I should know
about SIMPONI?").
Hepatitis B infection in people who carry the virus in their blood.
•Ifyou 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
