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Rethink Your LUPUS Story
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see Important Safety Information on pages 5-6 and accompanying Important Facts About BENLYSTA.
Ask your doctor about what option might be right for you.
You can also:
• Visit BENLYSTA.com and sign up to receive more information
• Call BENLYSTA Cares at 1-877-4-BENLYSTA (1-877-423-6597) for resources and support created just for patients like you
Important Safety InformationTell your healthcare provider right away if you have any of the symptoms listed below while receiving BENLYSTA
• Infections: fever, chills, pain or burning with urination, urinating often, coughing up mucus, or warm, red, or painful skin or sores on your body.
• Heart problems: chest discomfort or pain, shortness of breath, cold sweats, nausea, dizziness, or discomfort in other areas of the upper body.
• Allergic (hypersensitivity) reactions: itching, swelling of the face, lips, mouth, tongue, or throat, trouble breathing, anxiousness, low blood pressure, dizziness or fainting, headache, nausea, or skin rash. Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death.
In a clinical study in black patients, a reduction in disease activity was seen but was not statistically significant. Consult your healthcare provider to see if BENLYSTA is right for you.
©2020 GSK or licensor. BELBROC200040 March 2020 Produced in USA.
Rethink your lupus story
Keep the Conversation Going
SC Autoinjector (for adults)
SC Prefilled Syringe (for adults)
IV Infusion (for adults and children ≥5 years old)
Find out how inside
DO YOU HAVE LUPUS?(Systemic Lupus Erythematosus)
Return for your FREE Information Kit
Trademarks are owned by or licensed to the GSK group of companies.
Wh
at Is BEN
LYSTA
?BEN
LYSTA
is a prescription medication used to treat adults w
ith active system
ic lupus erythematosus (SLE or lupus) w
ho are receiving other lupus m
edicines.
It is not known if BEN
LYSTA
is safe and effective in people with
severe active lupus nephritis or severe active central nervous system
lupus, and it has not been studied in combination w
ith other biologics or intravenous cyclophospham
ide. Use of BEN
LYSTA
is not recom
mended in these situations.
Do not receive BEN
LYSTA
if you are allergic to belimum
ab or to any of the ingredients in BEN
LYSTA
.
Imp
ortan
t Safety Info
rmatio
n
BENLY
STA can cause serious side effects. Som
e of these side effects m
ay cause death. It is not known if BEN
LYSTA
causes these serious side effects. Tell your healthcare provider right aw
ay if you have any sym
ptoms of infections (such as fever, chills, coughing up
mucus, pain or burning w
ith urination, urinating often, or warm
, red, or painful skin or sores on your body), heart problem
s (such as chest discom
fort or pain, or shortness of breath), allergic reactions (itching, sw
elling of the face, lips, mouth, tongue, or throat, trouble
breathing, anxiousness, low blood pressure, dizziness or fainting,
headache, nausea, or skin rash) or mental health problem
s (such as thoughts of suicide or dying, trouble sleeping (insom
nia), new or
worse anxiety or depression, acting on dangerous im
pulses). Serious allergic reactions can happen on the day of, or in the days after, receiving BEN
LYSTA
and may cause death.
Tell you
r health
care pro
vider if yo
u:
• think you have an infection or have infections that keep com
ing back. You should not receive BEN
LYSTA
if you have an infection unless your healthcare provider tells you to.
• have or have had m
ental health problems such as depression or
thoughts of suicide.
• have recently received a vaccination or if you think you m
ay need a vaccination. If you are receiving BEN
LYSTA
, you should not receive live vaccines.
• are taking other m
edicines, including prescription and over-the-counter m
edicines, vitamins, and herbal supplem
ents.
• are allergic to other m
edicines.
• are receiving other biologic m
edicines, monoclonal antibodies, or
IV infusions of cyclophospham
ide (CY
TOX
AN
).
• have or have had any type of cancer.
• have any other m
edical conditions.
• are pregnant or plan to becom
e pregnant. It is not known
if BENLY
STA w
ill harm your unborn baby. You should talk to
your healthcare provider about whether to prevent pregnancy
while on BEN
LYSTA
. If you choose to prevent pregnancy, you should use an effective m
ethod of birth control while receiving
BENLY
STA and for at least 4 m
onths after the final dose of BEN
LYSTA
. Tell your healthcare provider right aw
ay if you become pregnant
during your treatment w
ith BENLY
STA or if you think you m
ay be pregnant.
Gla
xoS
mith
Klin
eP
O B
OX
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EE
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SIO
N K
S 6
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-994
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SS
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ILU
NIO
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STA
GE
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SS
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YIF
MA
ILE
DIN
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ED
STA
TES
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SIN
ES
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AIL
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O. 5
364
PO
STA
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WIL
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E P
AID
BY
AD
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SE
E
For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597).
2
Important Safety InformationDo not receive BENLYSTA if you are allergic to belimumab or to any of the ingredients in BENLYSTA.
The most important information to know about BENLYSTA
BENLYSTA can cause serious side effects. Some of these side effects may cause death. It is not known if BENLYSTA causes these serious side effects.
Tell your healthcare provider right away if you have any of the symptoms listed below while receiving BENLYSTA
• Infections: fever, chills, pain or burning with urination, urinating often, coughing up mucus, or warm, red, or painful skin or sores on your body.
• Heart problems: chest discomfort or pain, shortness of breath, cold sweats, nausea, dizziness, or discomfort in other areas of the upper body.
Important Safety Information continued on page 3.
lupus story.
For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597).
Please see Important Safety Information on pages 5-6 and accompanying Important Facts About BENLYSTA.
MOISTEN, FOLD, AND MAIL.
MOISTEN, FOLD, AND MAIL.10
What is BENLYSTA?BENLYSTA is a prescription medication used to treat patients with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines. Intravenous dosing of BENLYSTA is approved for adults and children aged 5 years and older. Subcutaneous dosing of BENLYSTA is only approved for adult patients.It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus, and it has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.
The Benefits of BENLYSTAAdult PatientsIn studies used in the approval of BENLYSTA,* when added to other medicines commonly used to treat lupus, compared to other lupus medicines alone, BENLYSTA has demonstrated: Superior reduction in disease activityMainly due to improvements in the immune system, muscles, mouth, joints and skin
Superior reduction in the chance of severe flaresReduction in the chance of severe flares occurred in two of the three studies†
Reduction in steroid dose‡
By 25% or more (to a daily dose of 7.5 mg or less) during Weeks 40-52, in patients receiving 7.5 mg or higher daily doses of steroid at the start of the study
wait to
IMPORTANT SAFETY INFORMATION (cont’d)Possible side effects of BENLYSTA (cont’d)
The most common side effects of BENLYSTA are nausea, diarrhea, fever, stuffy or runny nose and sore throat, cough, trouble sleeping, leg or arm pain, depression, headache, and pain, redness, itching, or swelling at the site of injection (when given subcutaneously). These are not all the possible side effects of BENLYSTA. Call your doctor for medical advice about side effects.
* BLISS-52, BLISS-76, and BLISS-SC.† A superior reduction in the chance of severe flares did not occur in the
BLISS-76 trial.‡ A numerical reduction in daily steroid dose was observed, but this difference
was not big enough for researchers to be sure that BENLYSTA was better than the placebo when added to patients’ current lupus medicine(s).
Your results may vary.
MO
ISTE
N, F
OLD
, AN
D M
AIL
.
• be
com
e pr
egna
nt w
hile
rec
eivi
ng B
ENLY
STA
. Tal
k to
you
r he
alth
care
pro
vide
r ab
out
enro
lling
in t
he B
ENLY
STA
Pre
gnan
cy
Regi
stry
. You
can
enr
oll i
n th
is r
egis
try
by c
allin
g 1-
877-
681-
6296
. The
pur
pose
of
this
reg
istr
y is
to
mon
itor
the
heal
th o
f yo
u an
d yo
ur b
aby.
• ar
e br
east
feed
ing
or p
lan
to b
reas
tfee
d. It
is n
ot k
now
n if
BEN
LYST
A p
asse
s in
to y
our
brea
st m
ilk. Y
ou a
nd y
our
heal
thca
re
prov
ider
sho
uld
talk
abo
ut w
heth
er o
r no
t yo
u sh
ould
rec
eive
BE
NLY
STA
and
bre
astf
eed.
Poss
ible
sid
e ef
fect
s o
f B
ENLY
STA
Prog
ress
ive
mul
tifoc
al le
ukoe
ncep
halo
path
y (P
ML)
is a
ser
ious
and
lif
e-th
reat
enin
g br
ain
infe
ctio
n. P
ML
can
resu
lt in
dea
th o
r se
vere
di
sabi
lity.
Tel
l you
r he
alth
care
pro
vide
r rig
ht a
way
if y
ou n
otic
e an
y ne
w o
r w
orse
ning
med
ical
pro
blem
s: m
emor
y lo
ss, t
roub
le t
hink
ing,
di
zzin
ess
or lo
ss o
f ba
lanc
e, d
ifficu
lty t
alki
ng o
r w
alki
ng, o
r lo
ss o
f vi
sion
.
Med
icin
es t
hat
affe
ct t
he im
mun
e sy
stem
, inc
ludi
ng B
ENLY
STA
, may
in
crea
se y
our
risk
of c
erta
in c
ance
rs.
The
mos
t co
mm
on s
ide
effe
cts
of B
ENLY
STA
are
nau
sea,
dia
rrhe
a,
feve
r, st
uffy
or
runn
y no
se a
nd s
ore
thro
at, c
ough
, tro
uble
sle
epin
g,
leg
or a
rm p
ain,
dep
ress
ion,
hea
dach
e an
d pa
in, r
edne
ss, i
tchi
ng, o
r sw
ellin
g at
the
site
of
inje
ctio
n (w
hen
give
n su
bcut
aneo
usly
). Th
ese
are
not
all t
he p
ossi
ble
side
eff
ects
of
BEN
LYST
A. C
all y
our
doct
or f
or
med
ical
adv
ice
abou
t si
de e
ffec
ts.
Oth
er Im
po
rtan
t In
form
atio
n
In c
linic
al s
tudi
es, t
here
hav
e be
en m
ixed
res
ults
reg
ardi
ng h
ow w
ell
BEN
LYST
A w
orks
in b
lack
/Afr
ican
Am
eric
an p
atie
nts.
The
refo
re,
you
shou
ld c
onsu
lt w
ith y
our
heal
thca
re p
rovi
der
to d
eter
min
e if
BEN
LYST
A is
rig
ht f
or y
ou.
For
mo
re in
form
atio
n, v
isit
ww
w.B
ENLY
STA
.co
m o
r ca
ll 1-
877-
4-B
ENLY
STA
(1-
877-
423-
6597
).
Plea
se s
ee a
cco
mp
anyi
ng
fu
ll Pr
escr
ibin
g In
form
atio
n a
nd
M
edic
atio
n G
uid
e.
Imp
ort
ant
Safe
ty In
form
atio
n (
con
t’d
)
©20
18 G
SK g
roup
of
com
pani
es o
r its
lice
nsor
. Pr
inte
d in
USA
. 100
6821
R0 A
ugus
t 20
18
Rece
ive
your
fre
e in
form
atio
n ki
tRe
gist
er to
day
to re
ceiv
e yo
ur F
REE
Info
rmat
ion
Kit,
with
tips
, too
ls, a
nd in
form
atio
n to
hel
p yo
u le
arn
mor
e ab
out B
ENLY
STA
(bel
imum
ab).
This
use
ful r
esou
rce
can
help
you
wor
k w
ith y
our h
ealth
care
pro
vide
r to
deci
de
if BE
NLY
STA
is ri
ght f
or y
ou. S
impl
y fil
l in
the
info
rmat
ion
belo
w, s
eal,
and
mai
l the
pos
tage
-pai
d ca
rd.
Plea
se n
ote
that
all
info
rmat
ion
is r
equi
red.
Trad
emar
ks a
re o
wne
d by
or l
icen
sed
to th
e G
SK g
roup
of c
ompa
nies
.
©20
18 G
SK g
roup
of c
ompa
nies
or i
ts li
cens
or.
Prin
ted
in U
SA. 1
0068
21R0
Aug
ust 2
018
GSK
bel
ieve
s you
r priv
acy
is im
port
ant.
By p
rovi
ding
you
r nam
e, a
ddre
ss, e
mai
l add
ress
, and
oth
er in
form
atio
n, y
ou c
ertif
y th
at y
ou a
re a
t lea
st 1
8 ye
ars o
ld a
nd th
at
you
are
givi
ng G
SK a
nd c
ompa
nies
wor
king
with
GSK
per
mis
sion
to m
arke
t or a
dver
tise
to y
ou a
cros
s mul
tiple
cha
nnel
s, e
.g.,
mai
l, em
ail,
web
sites
, onl
ine
adve
rtisi
ng,
appl
icat
ions
, and
ser
vice
s, re
gard
ing
the
med
ical
con
ditio
n(s)
in w
hich
you
hav
e ex
pres
sed
an in
tere
st, a
s wel
l as o
ther
hea
lth-r
elat
ed in
form
atio
n fro
m G
SK. G
SK w
ill
not s
ell o
r tra
nsfe
r you
r nam
e, a
ddre
ss, o
r em
ail a
ddre
ss to
any
oth
er p
arty
for t
heir
own
mar
ketin
g us
e. F
or a
dditi
onal
info
rmat
ion
rega
rdin
g ho
w G
SK h
andl
es y
our
info
rmat
ion,
ple
ase
see
our p
rivac
y st
atem
ent.
Nam
e
Addr
ess
City
Stat
e
Z
IP C
ode
Emai
l add
ress
I can’t begin a new chapter in my
Plea
se te
ll us
a li
ttle
mor
e ab
out y
ours
elf s
o w
e ca
n cu
stom
ize
the
mat
eria
ls w
e w
ill b
e se
ndin
g to
you
.
Whi
ch o
f the
fol
low
ing
stat
emen
ts b
est
desc
ribe
s yo
u? I
hav
e be
en d
iagn
osed
with
lupu
s
I
thin
k I m
ay h
ave
lupu
s
(s
yste
mic
lupu
s er
ythe
mat
osus
or S
LE)
I a
m a
fam
ily m
embe
r or f
riend
of s
omeo
ne d
iagn
osed
with
lupu
s
Non
e of
the
abov
e st
atem
ents
des
crib
es m
e
Hav
e yo
u be
en p
resc
ribe
d BE
NLY
STA?
W
hich
form
of B
ENLY
STA
did
you
r N
o
Y
es
rheu
mat
olog
ist p
resc
ribe
?
The
self-
inje
cted
form
T
he in
fuse
d fo
rm
I’m
not
sure
Whe
n di
d yo
u re
ceiv
e yo
ur fi
rst
dose
of B
ENLY
STA?
I
hav
e no
t yet
had
my
first
dos
e of
BEN
LYST
A M
M
Y
Y
Y
Y
Plea
se c
heck
the
box
tha
t be
st d
escr
ibes
how
you
feel
abo
ut t
he fo
llow
ing
stat
emen
t?
“Thi
nkin
g ab
out i
njec
ting
mys
elf w
ith B
ENLY
STA
mak
es m
e ne
rvou
s”
1. S
tron
gly
Dis
agre
e
2. S
omew
hat D
isag
ree
3
. Nei
ther
Agr
ee n
or D
isag
ree
4. S
omew
hat A
gree
5. S
tron
gly
Agr
ee
Cont
inue
STO
Phe
re, c
ompl
ete
addr
ess
info
, and
mai
l
STO
Phe
re, c
ompl
ete
addr
ess
info
, and
mai
l
Cont
inue
Cont
inue
CY
TOX
AN
is o
wne
d by
Bax
ter
Inte
rnat
iona
l Inc
. BEN
LYST
A is
ow
ned
by o
r lic
ense
d to
the
GSK
gro
up o
f co
mpa
nies
.
In a clinical study in black patients, a reduction in disease activity was seen but was not statistically significant. Consult your healthcare provider to see if BENLYSTA is right for you.
In a clinical study in black patients, a reduction in disease activity was seen but was not statistically significant. Consult your healthcare provider to see if BENLYSTA is right for you.
For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597).
2
Important Safety InformationDo not receive BENLYSTA if you are allergic to belimumab or to any of the ingredients in BENLYSTA.
The most important information to know about BENLYSTA
BENLYSTA can cause serious side effects. Some of these side effects may cause death. It is not known if BENLYSTA causes these serious side effects.
Tell your healthcare provider right away if you have any of the symptoms listed below while receiving BENLYSTA
• Infections: fever, chills, pain or burning with urination, urinating often, coughing up mucus, or warm, red, or painful skin or sores on your body.
• Heart problems: chest discomfort or pain, shortness of breath, cold sweats, nausea, dizziness, or discomfort in other areas of the upper body.
Important Safety Information continued on page 3.
lupus story.
For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597).
Please see Important Safety Information on pages 5-6 and accompanying Important Facts About BENLYSTA.
3
Is BENLYSTA right for you?
Ask yourself:
• Have you been diagnosed with systemic lupus erythematosus (SLE)?
• Are you currently taking medications to help treat your lupus?
• Has your lupus continued to be active?
If you answered yes to the above questions, you may benefit from adding BENLYSTA to your treatment. Talk to your doctor.
BENLYSTA works by reducing certain cells in your immune system that can make lupus active.
BENLYSTA offers adult patients the independence of self-injection, after you’ve been trained by your healthcare provider. This subcutaneous injection (under the skin of your abdomen or thigh) can be taken in the privacy of your own home, once a week, on the same day each week at a time that is convenient for you.
BENLYSTA Is available as a self-injection.
IMPORTANT SAFETY INFORMATION (cont’d)
Tell your healthcare provider right away if you have any of the symptoms listed below while receiving BENLYSTA (cont’d)
• Allergic (hypersensitivity) reactions: itching, swelling of the face, lips, mouth, tongue, or throat, trouble breathing, anxiousness, low blood pressure, dizziness or fainting, headache, nausea, or skin rash. Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death.
• Mental health problems and suicide: thoughts of suicide or dying, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety or depression, acting on dangerous impulses, other unusual changes in your behavior or mood, or thoughts of hurting yourself or others.
Important Safety Information continued on page 4.
BENLYSTA reduces disease activity more than other medicines alone, mainly due to improvements in the:
• Immune System
• Muscles
• Mouth
• Joints
• Skin
There’s a choice in how you receive BENLYSTA – as SC self-injection (for adults) or IV infusion
For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597).
Please see Important Safety Information on pages 5-6 and accompanying Important Facts About BENLYSTA.
4
With BENLYSTA, you have a choice
IMPORTANT SAFETY INFORMATION (cont’d)
Before receiving BENLYSTA also discuss with your healthcare provider if you:
• think you have an infection or have infections that keep coming back. You should not receive BENLYSTA if you have an infection unless your healthcare provider tells you to.
• have or have had mental health problems such as depression or thoughts of suicide.
• have recently received a vaccination or if you think you may need a vaccination. If you are receiving BENLYSTA, you should not receive live vaccines.
• are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• are allergic to other medicines.
• are receiving other biologic medicines, monoclonal antibodies, or IV infusions of cyclophosphamide (CYTOXAN).
• have or have had any type of cancer.
• have any other medical conditions.
Important Safety Information continued on page 7.
BENLYSTA comes in a range of options
Options What? Where? When?
Autoinjector (for adults)
Medicine that is automatically injected under the skin
• Self-administered or administered with the help of caregiver
Inject it yourself after you’ve received training
Once a week
Preparation and injection takes about 30 minutes
Prefilled Syringe (for adults)
Medicine that you manually inject under the skin
• Self-administered or administered with the help of caregiver
Inject it yourself after you’ve received training
Once a week
Preparation and injection takes about 30 minutes
Infusion (for adults and children ≥5 years old)
Medicine given by needle into your vein
Taken at your doctor’s office or an infusion center
Every four weeks, after the first three doses that are given at two-week intervals
Infusion takes about an hour
For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597).
Refer to accompanying Important Facts About BENLYSTA.
5
Do not receive BENLYSTA if you are allergic to belimumab or to any of the ingredients in BENLYSTA.
The most important information to know about BENLYSTA
BENLYSTA can cause serious side effects. Some of these side effects may cause death. It is not known if BENLYSTA causes these serious side effects.
Tell your healthcare provider right away if you have any of the symptoms listed below while receiving BENLYSTA
• Infections: fever, chills, pain or burning with urination, urinating often, coughing up mucus, or warm, red, or painful skin or sores on your body.
• Heart problems: chest discomfort or pain, shortness of breath, cold sweats, nausea, dizziness, or discomfort in other areas of the upper body.
• Allergic (hypersensitivity) reactions: itching, swelling of the face, lips, mouth, tongue, or throat, trouble breathing, anxiousness, low blood pressure, dizziness or fainting, headache, nausea, or skin rash. Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death.
• Mental health problems and suicide: thoughts of suicide or dying, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety or depression, acting on dangerous impulses, other unusual changes in your behavior or mood, or thoughts of hurting yourself or others.
Before receiving BENLYSTA also discuss with your healthcare provider if you:
• think you have an infection or have infections that keep coming back. You should not receive BENLYSTA if you have an infection unless your healthcare provider tells you to.
• have or have had mental health problems such as depression or thoughts of suicide.
Before receiving BENLYSTA also discuss with your healthcare provider if you: (cont’d)
• have recently received a vaccination or if you think you may need a vaccination. If you are receiving BENLYSTA, you should not receive live vaccines.
• are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• are allergic to other medicines.
• are receiving other biologic medicines, monoclonal antibodies, or IV infusions of cyclophosphamide (CYTOXAN).
• have or have had any type of cancer.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if BENLYSTA will harm your unborn baby. You should talk to your healthcare provider about whether to prevent pregnancy while on BENLYSTA. If you choose to prevent pregnancy, you should use an effective method of birth control while receiving BENLYSTA and for at least 4 months after the final dose of BENLYSTA. Tell your healthcare provider right away if you become pregnant during your treatment with BENLYSTA or if you think you may be pregnant.
• become pregnant while receiving BENLYSTA. Talk to your healthcare provider about enrolling in the BENLYSTA Pregnancy Registry. You can enroll in this registry by calling 1-877-681-6296. The purpose of this registry is to monitor the health of you and your baby.
• are breastfeeding or plan to breastfeed. It is not known if BENLYSTA passes into your breast milk. You and your healthcare provider should talk about whether or not you should receive BENLYSTA and breastfeed.
Important Safety Information continued on pages 6.
Important Safety Information
For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597).
Refer to accompanying Important Facts About BENLYSTA.
6
Possible side effects of BENLYSTA
• Progressive multifocal leukoencephalopathy (PML). PML is a serious and life-threatening brain infection. PML can result in death or severe disability. Tell your healthcare provider right away if you notice any new or worsening medical problems: memory loss, trouble thinking, dizziness or loss of balance, difficulty talking or walking, or loss of vision.
• Cancer. Medicines that affect the immune system, including BENLYSTA, may increase your risk of certain cancers.
Possible side effects of BENLYSTA (cont’d)
The most common side effects of BENLYSTA are nausea, diarrhea, fever, stuffy or runny nose and sore throat, cough, trouble sleeping, leg or arm pain, depression, headache, and pain, redness, itching, or swelling at the site of injection (when given subcutaneously). These are not all the possible side effects of BENLYSTA. Call your doctor for medical advice about side effects.
Important Safety Information (cont’d)
In a clinical study in black patients, a reduction in disease activity was seen but was not statistically significant. Consult your healthcare provider to see if BENLYSTA is right for you.
For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597).
Please see Important Safety Information on pages 5-6 and accompanying Important Facts About BENLYSTA.
7
Monitor Write down and keep track of all the changes in your symptoms, no matter how big or small the change may seem.
Share Always be open about your feelings, concerns, and any change in your health with your healthcare provider.
List List all your medications and ask your healthcare provider if BENLYSTA works with them.
Ask Ask your healthcare provider if BENLYSTA is right for you, and share any other questions or concerns you may have.
Bring a friend or family member Support from the people who care can make talking about new treatments easier. Bring someone you trust to your appointments; they can help you take notes and record any important information your doctor provides.
Tip: Use the doctor discussion guide on page 8 for a list of specific questions to ask at your next appointment.
Rethink your lupus story by talking to your healthcare provider
IMPORTANT SAFETY INFORMATION (cont’d)
Before receiving BENLYSTA also discuss with your healthcare provider if you: (cont’d)
• are pregnant or plan to become pregnant. It is not known if BENLYSTA will harm your unborn baby. You should talk to your healthcare provider about whether to prevent pregnancy while on BENLYSTA. If you choose to prevent pregnancy, you should use an effective method of birth control while receiving BENLYSTA and for at least 4 months after the final dose of BENLYSTA.
Tell your healthcare provider right away if you become pregnant during your treatment with BENLYSTA or if you think you may be pregnant.
Important Safety Information continued on page 8.
For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597).
Refer to accompanying Important Facts About BENLYSTA.
8
Talking about BENLYSTA
Here are some questions to discuss with your doctor that may help you both decide if it’s time to rethink your lupus story with BENLYSTA.
My lupus stays active while I am taking my current treatments. Is there anything more we can do?
How do I decide if this medicine is best for me?
What are the benefits and risks of adding BENLYSTA?
Which option would best suit my lifestyle?
How long will my treatment take?
What are my payment options?
Who should I contact if I have more questions about BENLYSTA?
When will BENLYSTA begin to work? How long do I need to stay on BENLYSTA?
How does BENLYSTA work to reduce my disease activity?
What are the possible side effects of BENLYSTA?
Please use the following space to write down any notes you may have.
IMPORTANT SAFETY INFORMATION (cont’d)
Before receiving BENLYSTA also discuss with your healthcare provider if you: (cont’d)
• become pregnant while receiving BENLYSTA. Talk to your healthcare provider about enrolling in the BENLYSTA Pregnancy Registry. You can enroll in this registry by calling 1-877-681-6296. The purpose of this registry is to monitor the health of you and your baby.
• are breastfeeding or plan to breastfeed. It is not known if BENLYSTA passes into your breast milk. You and your healthcare provider should talk about whether or not you should receive BENLYSTA and breastfeed.
Important Safety Information continued on page 9.
For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597).
Refer to accompanying Important Facts About BENLYSTA.
9
Have thoughts?
Take Notes:
IMPORTANT SAFETY INFORMATION (cont’d)
Possible side effects of BENLYSTA
• Progressive multifocal leukoencephalopathy (PML). PML is a serious and life-threatening brain infection. PML can result in death or severe disability. Tell your healthcare provider right away if you notice any new or worsening medical problems: memory loss, trouble thinking, dizziness or loss of balance, difficulty talking or walking, or loss of vision.
• Cancer. Medicines that affect the immune system, including BENLYSTA, may increase your risk of certain cancers.
Important Safety Information continued on page 10.
Please see Important Safety Information on pages 5-6 and accompanying Important Facts About BENLYSTA.
Take advantage of all that BENLYSTA Cares has to offer. Call 1-877-4-BENLYSTA (1-877-423-6597) today.
Free resources and support created just for patients like you BENLYSTA Cares offers resources for you – as you start on BENLYSTA and beyond. You can count on BENLYSTA Cares for:
• Refresher Injection Training: Build and strengthen your self-injection skills by phone with our trained nurses†
• Ongoing Injection Support: Nurses available by phone to talk you through your injections
* The BENLYSTA Co-pay Program helps eligible approved patients with their out-of-pocket costs for BENLYSTA up to [$15,000] every 12 months. Medicare-eligible patients, and patients enrolled in government-funded programs, are not eligible for the BENLYSTA Co-pay Program. Patients must submit a Service Request Form so their eligibility can be determined. For full Program Terms & Conditions please visit https://www.gskforyou.com/prescription-resource-assistance/program-terms-and-conditions/.
†Nurses from BENLYSTA Cares do not give medical advice. They are only able to answer questions about BENLYSTA. These may include help with self-injections, guidance for getting BENLYSTA, answers about the co-pay program, and other general information. They will direct you to your healthcare provider for answers to other types of questions.
Injection Support and Training
Access Support and BENLYSTA Co-pay Program
• Benefits Investigation: Help understanding your coverage for BENLYSTA
• BENLYSTA Co-pay Program: If approved, you could pay as little as $0 for BENLYSTA.
• Personalized Communications: Helpful tips, ideas, and info about living with lupus and BENLYSTA
• Nurse Line: Trained nurses to answer your questions about BENLYSTA by phone
• Medicine Storage: Carrying case and sharps disposal containers, free, upon request
Information and Tools
For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597).
Please see Important Safety Information on pages 5-6 and accompanying Important Facts About BENLYSTA.
MOISTEN, FOLD, AND MAIL.
MOISTEN, FOLD, AND MAIL.10
What is BENLYSTA?BENLYSTA is a prescription medication used to treat patients with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines. Intravenous dosing of BENLYSTA is approved for adults and children aged 5 years and older. Subcutaneous dosing of BENLYSTA is only approved for adult patients.It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus, and it has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.
The Benefits of BENLYSTAAdult PatientsIn studies used in the approval of BENLYSTA,* when added to other medicines commonly used to treat lupus, compared to other lupus medicines alone, BENLYSTA has demonstrated: Superior reduction in disease activityMainly due to improvements in the immune system, muscles, mouth, joints and skin
Superior reduction in the chance of severe flaresReduction in the chance of severe flares occurred in two of the three studies†
Reduction in steroid dose‡
By 25% or more (to a daily dose of 7.5 mg or less) during Weeks 40-52, in patients receiving 7.5 mg or higher daily doses of steroid at the start of the study
wait to
IMPORTANT SAFETY INFORMATION (cont’d)Possible side effects of BENLYSTA (cont’d)
The most common side effects of BENLYSTA are nausea, diarrhea, fever, stuffy or runny nose and sore throat, cough, trouble sleeping, leg or arm pain, depression, headache, and pain, redness, itching, or swelling at the site of injection (when given subcutaneously). These are not all the possible side effects of BENLYSTA. Call your doctor for medical advice about side effects.
* BLISS-52, BLISS-76, and BLISS-SC.† A superior reduction in the chance of severe flares did not occur in the
BLISS-76 trial.‡ A numerical reduction in daily steroid dose was observed, but this difference
was not big enough for researchers to be sure that BENLYSTA was better than the placebo when added to patients’ current lupus medicine(s).
Your results may vary.
MO
ISTE
N, F
OLD
, AN
D M
AIL
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• be
com
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egna
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hile
rec
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STA
Pre
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LYST
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In a clinical study in black patients, a reduction in disease activity was seen but was not statistically significant. Consult your healthcare provider to see if BENLYSTA is right for you.
In a clinical study in black patients, a reduction in disease activity was seen but was not statistically significant. Consult your healthcare provider to see if BENLYSTA is right for you.
Rethink Your LUPUS Story
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see Important Safety Information on pages 5-6 and accompanying Important Facts About BENLYSTA.
Ask your doctor about what option might be right for you.
You can also:
• Visit BENLYSTA.com and sign up to receive more information
• Call BENLYSTA Cares at 1-877-4-BENLYSTA (1-877-423-6597) for resources and support created just for patients like you
Important Safety InformationTell your healthcare provider right away if you have any of the symptoms listed below while receiving BENLYSTA
• Infections: fever, chills, pain or burning with urination, urinating often, coughing up mucus, or warm, red, or painful skin or sores on your body.
• Heart problems: chest discomfort or pain, shortness of breath, cold sweats, nausea, dizziness, or discomfort in other areas of the upper body.
• Allergic (hypersensitivity) reactions: itching, swelling of the face, lips, mouth, tongue, or throat, trouble breathing, anxiousness, low blood pressure, dizziness or fainting, headache, nausea, or skin rash. Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death.
In a clinical study in black patients, a reduction in disease activity was seen but was not statistically significant. Consult your healthcare provider to see if BENLYSTA is right for you.
©2020 GSK or licensor. BELBROC200040 March 2020 Produced in USA.
Rethink your lupus story
Keep the Conversation Going
SC Autoinjector (for adults)
SC Prefilled Syringe (for adults)
IV Infusion (for adults and children ≥5 years old)
Find out how inside
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Return for your FREE Information Kit
Trademarks are owned by or licensed to the GSK group of companies.
Wh
at Is BEN
LYSTA
?BEN
LYSTA
is a prescription medication used to treat adults w
ith active system
ic lupus erythematosus (SLE or lupus) w
ho are receiving other lupus m
edicines.
It is not known if BEN
LYSTA
is safe and effective in people with
severe active lupus nephritis or severe active central nervous system
lupus, and it has not been studied in combination w
ith other biologics or intravenous cyclophospham
ide. Use of BEN
LYSTA
is not recom
mended in these situations.
Do not receive BEN
LYSTA
if you are allergic to belimum
ab or to any of the ingredients in BEN
LYSTA
.
Imp
ortan
t Safety Info
rmatio
n
BENLY
STA can cause serious side effects. Som
e of these side effects m
ay cause death. It is not known if BEN
LYSTA
causes these serious side effects. Tell your healthcare provider right aw
ay if you have any sym
ptoms of infections (such as fever, chills, coughing up
mucus, pain or burning w
ith urination, urinating often, or warm
, red, or painful skin or sores on your body), heart problem
s (such as chest discom
fort or pain, or shortness of breath), allergic reactions (itching, sw
elling of the face, lips, mouth, tongue, or throat, trouble
breathing, anxiousness, low blood pressure, dizziness or fainting,
headache, nausea, or skin rash) or mental health problem
s (such as thoughts of suicide or dying, trouble sleeping (insom
nia), new or
worse anxiety or depression, acting on dangerous im
pulses). Serious allergic reactions can happen on the day of, or in the days after, receiving BEN
LYSTA
and may cause death.
Tell you
r health
care pro
vider if yo
u:
• think you have an infection or have infections that keep com
ing back. You should not receive BEN
LYSTA
if you have an infection unless your healthcare provider tells you to.
• have or have had m
ental health problems such as depression or
thoughts of suicide.
• have recently received a vaccination or if you think you m
ay need a vaccination. If you are receiving BEN
LYSTA
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IMPORTANT FACTS ABOUT BENLYSTAThe risk information presented here is not comprehensive. To learn more, talk to your healthcare provider (HCP). Visit www.BENLYSTA.com or call 1-877-423-6597 to get FDA-approved product labeling, including Medication Guide.
What is the most important information I should know about BENLYSTA?
BENLYSTA can cause serious side effects. Some of these side effects may cause death. It is not known if BENLYSTA causes these serious side effects. Tell your HCP right away if you get any of the following signs or symptoms while receiving BENLYSTA:
• Infections. Symptoms can include: fever, chills, pain or burning with urination, urinating often, coughing up mucus, warm, red, or painful skin or sores on your body.
• Heart problems. Symptoms can include: chest discomfort or pain, shortness of breath, cold sweats, nausea, dizziness, discomfort in other areas of the upper body.
• Allergic (hypersensitivity) reactions. Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death. Symptoms can include: itching, swelling of the face, lips, mouth, tongue, or throat, trouble breathing, anxiousness, low blood pressure, dizziness or fainting, headache, nausea, skin rash.
• Mental health problems and suicide. Symptoms can include: thoughts of suicide or dying, attempt to commit suicide, trouble sleeping, new or worse anxiety, new or worse depression, acting on dangerous impulses, other unusual changes in your behavior or mood, thoughts of hurting yourself or others.
What is BENLYSTA?
BENLYSTA is a prescription medicine used to treat patients with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines. Intravenous dosing of BENLYSTA is approved for adults and children aged 5 years and older. Subcutaneous dosing of BENLYSTA is only approved for adult patients.
It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus.
Who should not use BENLYSTA?
Do not use BENLYSTA if you are allergic to belimumab or any of the ingredients in BENLYSTA.
What should I tell my HCP before receiving BENLYSTA?
Before you receive BENLYSTA, tell your HCP about all of your medical conditions, including if you:
• think you have an infection or have infections that keep coming back. You should not receive BENLYSTA if you have an infection unless your HCP tells you to. See “What is the most important information I should know about BENLYSTA?”
• have or have had mental health problems such as depression or thoughts of suicide.
• have recently received a vaccination or if you think you may need a vaccination. If you are receiving BENLYSTA, you should not receive live vaccines.
• are allergic to other medicines.
• are receiving other biologic medicines, monoclonal antibodies, or IV infusions of cyclophosphamide (CYTOXAN).
• have or have had any type of cancer.
• are pregnant or plan to become pregnant. It is not known if BENLYSTA will harm your unborn baby. You should talk to your HCP about whether to prevent pregnancy while on BENLYSTA. If you choose to prevent pregnancy, you should use an effective method of birth control while receiving BENLYSTA and for at least 4 months after the final dose of BENLYSTA. Tell your healthcare provider right away if you become pregnant during your treatment with BENLYSTA or if you think you may be pregnant.
• are breastfeeding or plan to breastfeed. It is not known if BENLYSTA passes into your breast milk. You and your HCP should talk about whether or not you should receive BENLYSTA and breastfeed.
Tell your HCP about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of BENLYSTA?
BENLYSTA can cause serious side effects including:
• Progressive multifocal leukoencephalopathy (PML). PML is a serious and life-threatening brain infection. Your chance of getting PML may be higher if you are treated with medicines that weaken your immune system, including BENLYSTA. PML can result in death or severe disability. Tell your HCP right away if you notice any new or worsening medical problems such as: memory loss, trouble thinking, dizziness or loss of balance, difficulty talking or walking, loss of vision.
• Cancer. BENLYSTA may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.
The most common side effects of BENLYSTA include: nausea, diarrhea, fever, stuffy or runny nose and sore throat, cough, trouble sleeping, leg or arm pain, depression, headache, and pain, redness, itching, or swelling at the site of injection.
These are not all the possible side effects of BENLYSTA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Keep BENLYSTA and all medicines out of reach of children.CYTOXAN is owned by Baxter International Inc. BENLYSTA is owned by or licensed to the GSK group of companies.
GlaxoSmithKline Research Triangle Park, NC 27709
©2019 GSK or licensor.BELBRFS190001 May 2019Produced in USA. 0002-0001-91