W h a t a re th e possible sid e effe cts w ith S IM P O N I?
S IM P O N I can cause serious side effects, including:
S ee " 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 erious In fectio n s
H ep atitis B in fe ctio n in p eo ple w h o carry th e virus in th e ir blood.
• If you are a carrier of the hepatitis B virus (a virus th a t affects
the liver), the virus can becom e active w h ile you use S IM P O N I.
Your doctor m ay do blood tests before you start tre a tm e n t w ith
S IM P O N I and w h ile you are using S IM P O N I. Tell yo u r doctor if
you have any of the follow ing sym ptom s of a possible hepatitis
B infection:
•fe e l very tired
•s k in or eyes lo o k y e llo w
•little or no appetite
•vom iting
•m u s c le aches
•d a rk urine
•c la y -c o lo re d bow el
m ovem ents
•fe v e rs
•ch ills
•s to m a c h discom fort
•skin rash
H eart fa ilu re , in clu din g n e w h e a rt fa ilu re or w o rs e n in g of h eart
fa ilu re th a t you a lre a d y have. N e w or w o rs e h eart failure can
happen in people w h o use T N F -b lo c ker m edicines like S IM P O N I.
• If you have h eart failure, your condition should be w a tc h e d
closely w h ile you take S IM P O N I.
• Call yo u r doctor right a w a y if you g et n e w or w orsen ing sym ptom s
of h eart failu re w h ile taking S IM P O N I (such as shortness of breath
or sw elling of yo u r lo w e r legs or feet).
N ervou s System P roblem s
Rarely, people using T N F -b lo c ker m edicine have nervous system
problem s such as m ultiple sclerosis.
•T e ll your doctor right a w a y if you g et any of these sym ptom s:
•v is io n changes
• w e a k n e s s in your arm s or legs
•n u m b n e s s o rting lin g in any part of your body
Liver Problem s
Liver problem s can happen in people w h o use TN F-b locker
m edicines, including S IM P O N I. T hese problem s can lead to liver
failure and death. Call yo u r doctor right a w a y if you have any of
the se sym ptom s:
•fe e l very tired
•s k in or eyes look y ello w
• poor appetite or vom iting
• pain on the right side of your stom ach (abdom en)
B lood Problem s
Low blood counts have been seen w ith o ther T N F blockers. Your
body m ay not m ake enough blood cells th a t help figh t infections or
help stop bleeding. Sym ptom s include fever, bruising or bleeding
easily, or looking pale. Your doctor w ill c h e c k y o u r blood counts
before and during tre a tm e n t w ith S IM P O N I.
Com m on sid e effe cts w ith S IM P O N I include:
• upper respiratory tra c t infection
«sinus infection (sinusitis)
nausea
abnorm al liver tests
redness at the site of injection
high blood pressure
bronchitis
dizziness
•flu
•ru n n y nose
•fe v e r
•c o ld sores
•n u m b n e s s orting lin g
O ther side effects w ith S IM P O N I include:
• Im m une System Problem s. Rarely, people using TN F-b locker
m edicines have developed sym ptom s th a t are like the sym ptom s
of lupus. Tell your doctor if you have any of these sym ptom s:
• a rash on y o u r c h e e k s or o th e r p arts o f th e body
• s e n sitivity to th e sun
• n e w jo in to r m u scle pains
• b eco m in g v e ry tire d
• c h e s t pain or s h o rtn es s o f b reath
• sw ellin g o f th e fe e t, an kles, a n d /o r legs
• P s o riasis. S om e people using S IM P O N I had n e w p so riasis or
w o rs e n in g o f pso riasis th a t th e y a lre a d y had. Tell y o u r d o c to r
if you d evelo p red s c a ly p a tc h e s or raised bum ps th a t a re filled
w ith pus. Your d o c to r m ay d e c id e to stop y o u r tre a tm e n t w ith
S IM P O N I.
• A lle r g ic R e a c tio n s . A lle rg ic re a c tio n s can h ap pen in people
w h o use T N F -b lo c k e r m e d ic in e s . Call y o u r d o c to r rig h t a w a y if
you h ave an y o f th e s e sym p to m s o f an a lle rg ic rea ction :
• hives
• s w o lle n fa c e
• b reath in g tro u b le
• c h e s t pain
T h e s e a re not all of th e side e ffe c ts w ith S IM P O N I. Tell yo u r
d o c to r a b o u t an y side e ffe c t th a t b o th ers you or d oe s not go
a w a y . Call yo u r d o c to r fo r m e d ic a l ad v ic e a b o u t side e ffe c ts .
You m a y re p o rt side e ffe c ts to th e FDA a t 1-8 0 0 -F D A -1 088.
H o w do I s to re S IM P O N I?
• R e frig e ra te S IM P O N I a t3 6 °F to 46°F (2°C to 8°C).
• Do not fre e z e S IM P O N I.
• K eep S IM P O N I in th e c arto n to p ro te c t it fro m light w h e n
n ot being used.
• Do not sh ake S IM P O N I.
K eep S IM P O N I an d a ll m e d ic in e s o u t o f th e re a c h of c h ild re n .
G e n e ra l In fo rm a tio n a b o u t S IM P O N I
M e d ic in e s a re so m e tim e s p re s c rib e d fo r p urpo ses o th e r tha n
th o s e listed in th e M e d ic a tio n G uide. Do not use S IM P O N I fo r
a co n ditio n fo r w h ic h itw a s n ot p re s c rib e d .
• Do not give S IM P O N I to o th e r p eo p le, even if th e y h ave th e
s am e co n ditio n th a t you h ave. It m ay h arm th e m .
• This M e d ic a tio n G uide su m m a rize s th e m o st im p o rtan t
in fo rm atio n a b o u t S IM P O N I. If you w o u ld like m ore
in fo rm atio n , ta lk to y o u r doctor. You can ask y o u r d o c to r or
p h a rm a c is t fo r in fo rm atio n a b o u t S IM P O N I th a t is w ritte n fo r
health professionals. For m ore inform ation go to w w w .sim poni.com
or call 1-800-457 -63 99.
W h a t a re th e in g re d ie n ts in S IM P O N I?
A c tiv e ingred ien t: golim u m ab .
In a c tiv e in gred ien ts: L -h istid ine , L -h istid ine m o n o h yd ro c h lo rid e
m o n o h y d ra te , so rb itol, p o ly s o rb a te 80, and w a te r fo r in jectio n.
S IM P O N I d oe s n ot c o n tain p re s e rv a tiv e s .
M a n u fa c tu re d by:
C e n to c o r Ortho B io te ch Inc.
Florsham , PA 19044
US L icen se N o. 1821
R evised: 11/2009
25GL09421
T his M e d ic a tio n G uide h as b een a p p ro ved by th e U .S. Food and
D rug A d m in istra tio n .
• TM
S im p o n i
golimumab
