Medication Guide
MEDICATION GUIDE
SIMPONI® (SIM-po-nee)
(golimumab)
Read
the
M edication
Guide
that
com es
w ith
SIM PON I
before you
start takin g it and
each time you
get a
refill.
There
m ay
be
new
inform ation.
Th is
M edication
Guide
does not take the p lace of talking with your doctor about
your
m edical
condition
or
treatm ent.
It
is
im portant
to
rem ain under your doctor's care w hile using SIM P O N I.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD
KNOW ABOUT SIMPONI?
SIM PO M I is a m edicine that affects your imm une system ,
SIM PO M I
can low er the ability of your immune system to
fight
infections.
Som e
people
have
se rio u s
infections
w hile
taking
S IM P O N I,
including
tu b e rcu lo sis
(TB),
and
in fe ctio n s
ca u se d
by
b acte ria,
fungi,
or
v iru se s
that
sp read
throughout
their
body.
Som e
people
have
died
from these se rio u s infections.
•
Your
doctor
should
test
you
for
T B
before
starting
SIM P O N I.
•
Your doctor should
m onitor you
clo se ly for sig n s
and
sym ptom s of T B during treatm ent with 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 sa y s it is okay.
Before starling SIMPONI, tell your doctor if you:
■
think
you
have
an
infection
or
have
sym ptom s
of
an
infection such as:
sh o rtn ess of breath
feel very tired
blood in phlegm
w eight loss
cough
* fever, sw eat, or ch ills
* w arm , red, or painful skin
or so res on your body
* m u scle a ch e s
* diarrhea or stom ach pain
*
burning w hen you urinate or
urinate more often than norm al
are being treated for an infection
get a lot of infections or have infections that keep
com ing back
have diabetes, HIV, or a w e a k im m une system .
People
w ith
th e se
co n d itio n s
have
a
h igh e r
c h a n ce
for
infections.
have T B , or have been in clo se co n tact with som eone
w ith T B
*
live,
have
lived,
or
traveled
to
certain
parts
of
the
country {such as the Ohio and M ississip p i River valleys
and the Southw est) w here there is an in creased ch an ce
for
getting
certain
kin d s
of
fungal
in fe ctio n s
(h isto p lasm o sis,
co ccid io id o m y co sis,
b la sto m yco sis).
T h e se infections m ay happen or becom e more severe if
you use SIM P O N I. A sk your doctor, if you do not know
if you have lived in an area w h ere these infections are
com m on.
*
have or have had hepatitis В
*
use
the
m ed icin e
O ren cia
{a b a ta ce p t),
K in e re t
(anakinra), or Rituxan (rituxim ab)
After starting SIMPONI,
call
your doctor right aw ay
if you
have
any sym ptom s
of an
infection.
SIM P O N I
can
m ake
you
more
likely
to
get
infections
or
m ake
w o rse
any
infection that you have.
Cancer
*
There have been c a se s of unusual c a n c e rs in children
and te en age patients taking TN F-b lo ckin g agents.
*
For children
and
adults taking T N F -b lo ck e r m edicines,
including
SIM P O N I, the
ch a n c e s of getting
lym phom a
or other c a n ce rs m ay in cre ase .
*
P e o p le
w ith
in flam m ato ry
d is e a s e s
in clu d in g
rheum atoid
arthritis,
psoriatic
arthritis,
or
ankylosing
spondylitis,
e sp e cia lly those
with
very active
d ise ase ,
m ay be more likely to get lym phom a.
What is SIMPONI?
S IM P O N I
is
a
p rescrip tio n
m edicine
ca lle d
a
Tum or
N e cro sis Factor (TNF) blocker. S IM P O N I is used in adults:
*
w ith the
m edicine m ethotrexate to treat m oderately to
severely active rheum atoid arthritis (RA)
*
to
treat
active
p soriatic
arthritis
(P sA )
alone
or
with
m ethotrexate
*
to treat active ankylosing spondylitis (A S )
You
may continue to use other m ed icin es that help treat
your
condition
w hile
taking
S IM P O N I,
su ch
as
n o n -
ste ro id a l
an ti-in fla m m a to ry
d ru g s
(N S A ID s )
and
prescription steroids, as recom m ended by your doctor.
What should I tell my doctor before starting treatment with
SIMPONI?
S IM P O N I
m ay
not
be
right
for
you.
B efo re
starting
S IM P O N I,
tell
your
doctor
about
all
yo ur
m ed ical
conditions, including if you:
*
have
an
infection
{see
"W h at
is
the
m ost
im portant
inform ation I should know about SIM P O N I?").
*
have
or
have
had
lym phom a
or
any
other
type
of
can ce r.
*
have or had heart failure.
*
have or have had a condition that affects your nervous
system , su ch a s m ultiple scle ro sis.
*
have
recen tly re ceive d
or are sch e d u le d to
re ce ive a
v a c c in e .
People
takin g
S IM P O N I
should
not
receive
live v a ccin e s. People taking S IM P O N I can receive non-
live v a ccin e s.
*
are alle rgic to rubber or latex. The needle co ver on the
prefilled syrin ge and
S m a rtJe ct® autoinjector contains
dry natural rubber,
*
are pregnant or planning to becom e pregnant. It is not
known if S IM P O N I w ill harm your unborn baby.
*
are breastfeeding, You and your doctor should decide if
you w ill take SIM P O N I or breastfeed. You should not do
both w ithout talking to your doctor first.
Tell your doctor about all the medicines you take,
including
p rescrip tio n
and
non-p rescrip tio n
m e d icin es,
vitam ins,
and herbal supplem ents. Esp ecially, tell your doctor if you
use:
*
O R E N C IA (abatacept), K IN E R E T (anakinra), or R IT U X A N
{rituxim ab). You should not take SIM P O N I w hile you are
also taking O R E N C IA or K IN E R E T , Your doctor may not
w an t
to
give
you
S IM P O N I
if
you
have
received
R IT U X A N recently.
*
A n o th e r
T N F -b lo c k e r
m e d icin e .
You
should
not
take
S IM P O N I
w hile
you
are
also
taking
R E M IC A D E
(in flixim a b ),
H U M IR A
(a d a lim u m a b f,
E N B R E L
(etanercept), or C IM Z IA (certolizum ab pegol).
A sk your doctor if you are not sure if your m edicine is one
listed above.
Keep a list of all your m edications with you to sh o w your
doctor and p h arm acist each time you get a new m edicine.
How should I use SIMPONI?
*
S IM P O N I
is
given
as
an
injectio n
under
the
skin
(su b cu tan eo u s injection or SC ).
*
SIM P O N I should be injected one time each month.
*
If your doctor d e cid e s that you or a
ca re g ive r m ay be
able to
give your injections of SIM P O N I
at home, you
should receive training on the right w a y to prepare and
inject SIM P O N I, Do not try to inject S IM P O N I yo urself
until
you
have
been
show n the
right w a y to
give the
injections by your doctor or nurse,
*
Use SIM P O N I exactly a s p rescrib ed by your doctor.
*
SIM P O N I
com es
in
a
prefilled
syrin ge
or
S m a rtJe ct
autoinjector. Your doctor will p rescrib e the type that is
best for you.
