M e d ic a tio n G uide
M E D IC A T IO N G UIDE
SIM PO N I™ (S IM -p o -n e e )
(go lim u m ab)
R ead th e M e d ic a tio n G uide th a t co m es w ith S IM P O N I before
yo u s tart takin g it and e a c h tim e yo u g et a refill. T h e re m a y b e
n e w inform ation. This M e d ic a tio n G uide does not ta k e th e p la c e
o f talking w ith y o u r d o c to r ab o u t y o u r m ed ical condition or
tre a tm e n t. It is im p ortan t to rem ain u n d e ry o u r d o c to rs c a re w h ile
using S IM P O N I.
W h a t is th e m ost im p ortan t inform ation I should k n o w
ab o ut S IM P O N I?
S IM P O N I is a m ed icin e th a t a ffe c ts y o u r im m un e system .
S IM P O N I can lo w e r th e ability o f y o u r im m une s y s te m to fig h t
infectio n s. S o m e p eo ple h ave serious infections w h ile taking
S IM P O N I, including tu b ercu lo sis (TB ), and infections ca u s e d by
b a c te ria , fungi, o r viruses th a t sp rea d th ro u g h o u t th e ir body. S om e
p eo ple h ave died fro m th e s e serious infections.
• Your d octo r should te s t you fo r TB before starting S IM P O N I.
• Your doctor should m onitor you closely for signs and
sym ptom s of TB during tre a tm e n t w ith S IM P O N I.
You should not start taking S IM P O N I if you have any kind of
infection unless your doctor says it is okay.
B efore starting S IM P O N I, te ll yo u r docto r if you:
• think you have an infection or have sym ptom s of an
infection such as:
' fever, s w eat, or chills
' m uscle aches
' cough
' shortness of breath
' blood in phlegm
' w e ig h t loss
•w a rm , red, or painful skin
or sores on your body
• diarrhea or stom ach pain
• burning w h e n you urinate or
urinate m ore often than norm al
•fe e l very tired
• are being treated for an infection
• g et a lot of infections or have infections th a t keep com ing back
• have diabetes, HIV, or a w e a k im m une system . People w ith these
conditions have a higher ch an ce for infections.
• have TB, or have been in close c o n tac t w ith som eone w ith TB
• live, have lived, or traveled to certain parts of the country (such as
the Ohio and M ississippi River valleys and the S outhw est) w h e re
th e re is an increased ch an ce for getting certain kinds of fungal
infections (histoplasm osis, coccidioidom ycosis, blastom ycosis).
These infections m ay happen or becom e m ore severe if you use
S IM P O N I. A s k y o u r doctor if you do not kn o w if you have lived in
an area w h e re these infections are com m on.
• have or have had hepatitis В
• use the m edicine O rencia (ab atac ep t), K ineret (anakinra),
or Rituxan (rituxim ab)
A fte r starting S IM P O N I, call yo u r doctor right a w a y if you have any
sym ptom s of an infection. S IM P O N I can m ake you m ore likely to get
infections or m ake w o rs e any infection th a t you have.
C an cer
• T h e re h ave b een c as es o f unusual c a n c e rs in children and
te e n a g e patients takin g T N F -b lo c kin g agents.
• For children and adults taking T N F -b lo c k e r m ed icin es, including
S IM P O N I, th e c h a n c e s of getting lym phom a o r o th e r c a n c e rs
m ay in crea se.
• P eop le w ith in fla m m a to iy d ise a s e s including rheum atoid
arthritis, pso riatic arthritis, or ankylosing spondylitis, esp ecia lly
th o se w ith v e ry activ e d ise a s e , m ay be m o re likely to get
lym phom a.
W h a t is S IM P O N I?
S IM P O N I is a prescrip tio n m ed icin e called a tu m o r necrosis
fa c to r (TN F) blocker. S IM P O N I is used in adults:
• w ith th e m ed icin e m eth o tre x a te to tre a t m o d e ra te ly to se v e re ly
active rh eu m ato id arthritis (RA)
• to tre a t active psoriatic arthritis (PsA ) alone or w ith
m eth o tre x a te
• to tre a t active ankylosing spondylitis (A S)
You m a y con tin u e to use o th er m ed icin es th a t help tre a t yo u r
condition w h ile takin g S IM P O N I, such as n o n -stero ida l an ti-
in fla m m a to ry drugs (N S A ID s ) and prescrip tio n steroids, as
re c o m m e n d e d by y o u r doctor.
W h a t should I te ll m y d octo r b efore starting treatm en t
w ith S IM P O N I?
S IM P O N I m ay not be right for you. B efore starting S IM P O N I,
tell your doctor about all your m edical conditions, including if you:
" W h a t is th e m ost im p ortan t inform ation
I should k n o w ab o ut S IM P O N I? ").
• have or have had lym phom a or any other type of cancer.
• have or had h eart failure.
• have or have had a condition th a t affects your nervous system ,
such as m ultiple sclerosis.
• have recen tly received or are scheduled to receive a vaccine.
People taking S IM P O N I should not receive live vaccines. People
taking S IM P O N I can receive non-live vaccines.
• are allergic to rubber or latex. The needle cover on the prefilled
syringe and S m a rtJ e c t autoinjector contains dry natural rubber.
• are preg n ant or planning to beco m e pregnant. It is not know n if
S IM P O N I w ill harm your unborn baby.
• are breastfeeding. You and your doctor should d ecid e if you
w ill take S IM P O N I or breastfeed. You should not do both
w ith o u t talking to your doctor first.
Tell yo u r d octo r ab o ut a ll th e m ed ic in e s you ta k e , including
prescription and non-prescription m edicines, vitam ins, and herbal
supplem ents. Especially, tell your doctor if you use:
• O R EN C IA (ab atac ep t), KINERET (anakinra), or R ITU XA N
(rituxim ab). You should not take S IM P O N I w h ile you are also
taking O R EN C IA or KINERET. Your doctor m ay not w a n t to give
you S IM P O N I if you have received R ITU X A N recently.
• Another TNF-blocker medicine. You should nottake S IM PO N I w hile you
are also taking R EM IC A D E (inflixim ab), H U M IR A (adalim um ab),
E N B R E L (etan ercep t), or C IM Z IA (certolizum ab pegol).
A skyo u r doctor if you are not sure if your m edicine is one listed above.
Keep a list of all yo u r m edications w ith you to s h o w yo u r doctor and
pharm acist each tim e you g et a n e w m edicine.
H o w should I use S IM P O N I?
• S IM P O N I is given as an injection u n d e rth e skin (subcutaneous
injection or SC).
• S IM P O N I should be injected one tim e each m onth.
• If yo u r doctor d ecid es th a ty o u or a careg iver m ay be able to give
your injections of S IM P O N I at hom e, you should rec eive training
on the rig h tw a y to prepare and inject S IM P O N I. Do not try to
inject S IM P O N I yourself until you have been show n the right w a y
to give the injections by your doctor or nurse.
• Use S IM P O N I exactly as prescribed by yo u r doctor.
• S IM P O N I com es in a prefilled syringe or Sm artJect™ autoinjector.
Your doctor w ill prescribe the type th a t is b e s tfo ry o u .
• S e e th e detailed
Patient Instructions for Use
at the end of this
M ed icatio n Guide for instructions about the rig h tw a y to prepare
and give your S IM P O N I injections at hom e.
• Do n o tm iss any doses of S IM P O N I. Ify o u fo rg e t to use S IM P O N I,
inject your dose as soon as you rem em ber. Then, take your next
dose a ty o u r regular scheduled tim e. In case you are not sure
w h e n to inject S IM P O N I, call your doctor or pharm acist.
