•
S e e the detailed
P a t i e n t I n s t r u c t i o n s f o r U s e
at the end
of this M edication Guide for instructio ns about the right
w ay to prepare and give your SIM PO N I injections at home.
•
Do not m iss any d o se s of S IM P O N I. If you forget to use
S IM P O N I, inject your dose
as soon as you
remember.
Then, take your next dose at your regular scheduled time.
In c a se you are not sure w hen to inject S IM P O N I, call
your doctor or pharm acist.
What are the possible side effects with SIMPONI?
S IM P O N I can ca u se se rio u s side effects, including:
S e e
"What is the
most important information
I should
know about SIMPONI?"
Serious Infections
Hepatitis B infection in people who carry the virus in their
blood.
•
If you are a carrier of the hepatitis B virus (a virus that
affects the liver), the virus can becom e active w hile you
use
SIM P O N I.
Your doctor m ay
do
blood tests
before
you
start treatm ent with
SIM P O N I
and
w hile
you
are
using SIM P O N I. Tell your doctor if you have any of the
follow ing sym ptom s of a possible hepatitis B infection:
•
feel very tired
•
ch ills
•
clay-co lo re d bow el
•
vom iting
m ovem ents
•
stom ach discom fort
•
skin or eyes look yello w
•
m u scle a ch e s
•
fe ve rs
•
skin rash
•
little or no appetite
•
dark urine
Heart failure, including new heart failure or worsening of heart
failure that you already have.
N ew or w o rse heart failure can
happen
in
people
w ho
use
TN F-b lo cke r
m edicines
like
SIM P O N I.
•
If
you
have
heart
failure,
your
condition
should
be
w atch ed clo se ly w hile you take SIM P O N I.
•
Call your doctor right aw a y if you get new or w o rsen in g
sym ptom s of heart failure w hile taking S IM P O N I (such
as sh o rtn ess of breath or sw ellin g of your low er le g s or
feet).
Nervous System Problems
Rarely,
people
using
T N F -b lo ck e r
m ed icin es,
including
S IM P O N I, have nervous system problem s su ch a s multiple
scle ro sis.
•
Tell
your
doctor
right
a w a y
if
you
get
any
of
these
sym ptom s:
• vision ch a n g e s
• w e a k n e ss in your arm s or legs
• num bness or tingling in any part of your body
Liver Problems
Liver
problem s
can
happen
in
people
w ho
use
T N F-
b lo cker
m edicines,
including
S IM P O N I. T h e se
problem s
can lead to liver failure and death. Call your doctor right
a w a y if you have any of these sym ptom s:
•
feel very tired
•
skin or e ye s look yello w
•
poor appetite or vom iting
•
pain on the right side of your sto m ach (abdom en)
Blood Problems
Lo w
blood
co u n ts
have
been
se en
w ith
other
T N F -
blo ckers. Your body m ay not m ake enough blood ce lls that
help
fight
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
your
blood
counts
before
and
during treatm ent w ith SIM P O N I.
Common side effects with SIMPONI include:
• upper respiratory
» fe ve r
tra ct infection
• high blood p ressu re
• sin u s infection (sin u sitis)
• cold so res
• nau sea
• bronchitis
• flu
• num bness or tingling
• abnorm al liver te sts
• d izzin ess
• runny nose
• redness at the
site of injection
Other side effects w ith SIM P O N I include:
•
Immune
System
Problems.
Rarely,
people
using
T N F-
b lo cker m ed icin es have developed
sym ptom s that are
like the sym ptom s of Lupus. Tell your doctor if you have
any of these sym ptom s:
• a rash on your ch e e ks or other parts of the body
• sen sitivity to the sun
• new joint or m uscle pains
• becom ing very tired
• ch e st pain or sh o rtn ess of breath
• sw ellin g of the feet, ankles, and/or legs
•
Psoriasis.
So m e
people
using
S IM P O N I
had
new
p so ria sis
or w o rsen in g
of p so ria sis they
alread y had.
Tell
your
doctor if you
develop
red
sc a ly
p atch es
or
raised bum ps that are filled with pus. Your doctor m ay
d ecid e to stop your treatm ent w ith SIM P O N I.
•
Allergic
Reactions.
A lle rg ic
reactions
can
happen
in
people
w ho
use
T N F -b lo ck e r
m e d icin e s.
Call
your
doctor right a w a y if you have any of these sym ptom s of
an a lle rgic reaction:
•
hives
•
breathing trouble
•
sw ollen fa ce
•
ch e st pain
Th e se
are
not all
of the
side
effects with
SIM P O N I. Tell
your doctor about any side effect that bothers you or does
not go
aw ay.
Call
your doctor for m edical
advice
about
side
effects.
You
m ay
report side
effects to the
FD A
at
1 -800-FD A - 1088.
How do I store SIMPONI?
•
R efrigerate SIM P O N I at 36°F to 46°F (2°C to 8°C).
•
Do n o tfre e ze SIM P O N I.
•
Keep SIM PO N I in the carton to protect it from light when
not being used.
•
Do not sh ake SIM P O N I.
Keep SIMPONI and all medicines out of the reach of children.
General Information about SIMPONI
•
M e d icin e s
are
som etim es
p re scrib e d
for
p u rp o ses
other than those listed in the M edication Guide. Do not
use
SIM P O N I
for
a
condition
for
w h ich
it
w a s
not
prescribed.
•
Do not give SIM P O N I to other people, even if they have
the sam e condition that you have. It m ay harm them.
•
Th is
M edication
Guide sum m arizes the
m ost important
information
about
SIM P O N I.
If
you
w ould
like
more
information, talk to your doctor. You can ask your doctor
or
pharm acist
for
information
about
SIM P O N I
that
is
written for health professionals. For more information go
to w w w .sim poni.com or call 1-800-457-6399.
What are the ingredients in SIMPONI?
A ctive ingredient: golim um ab.
In a ctiv e
in g re d ie n ts:
L-h istid in e ,
L-h istid in e
m ono-
hydrochloride m onohydrate, sorbitol,
polysorbate 80, and
w ater for injection. SIM PO N I does not contain preservatives.
M anufactured by:
Cento cor Ortho B io tech Inc.
Horsham , PA 19044
U S Lice n se No. 1821
Revised: 12/2010
2 5 S M 10233
T h is
M edication
Guide
h as
been
approved
by
the
U.S.
Food and Drug Adm inistration.
Sim poni
golimumab
