12
Rethink Your LUPUS Story 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. Find out how inside

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Page 1: Keep the Conversation Going Rethink Your LUPUS Story be ... · By providing your name, address, email address, and other information, you certify that you are at least 18 years old

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.

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Page 2: Keep the Conversation Going Rethink Your LUPUS Story be ... · By providing your name, address, email address, and other information, you certify that you are at least 18 years old

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

)

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SK g

roup

of

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lice

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. Pr

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t 20

18

Rece

ive

your

fre

e in

form

atio

n ki

tRe

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day

to re

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ur F

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rmat

ion

Kit,

with

tips

, too

ls, a

nd in

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atio

n to

hel

p yo

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arn

mor

e ab

out B

ENLY

STA

(bel

imum

ab).

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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

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.

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ust 2

018

GSK

bel

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s you

r priv

acy

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port

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rovi

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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

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ddre

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ail a

ddre

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any

oth

er p

arty

for t

heir

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ketin

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e. F

or a

dditi

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info

rmat

ion

rega

rdin

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w G

SK h

andl

es y

our

info

rmat

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ple

ase

see

our p

rivac

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atem

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Addr

ess

City

Stat

e

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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

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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.

Page 3: Keep the Conversation Going Rethink Your LUPUS Story be ... · By providing your name, address, email address, and other information, you certify that you are at least 18 years old

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

Page 4: Keep the Conversation Going Rethink Your LUPUS Story be ... · By providing your name, address, email address, and other information, you certify that you are at least 18 years old

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

Page 5: Keep the Conversation Going Rethink Your LUPUS Story be ... · By providing your name, address, email address, and other information, you certify that you are at least 18 years old

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

Page 6: Keep the Conversation Going Rethink Your LUPUS Story be ... · By providing your name, address, email address, and other information, you certify that you are at least 18 years old

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.

Page 7: Keep the Conversation Going Rethink Your LUPUS Story be ... · By providing your name, address, email address, and other information, you certify that you are at least 18 years old

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.

Page 8: Keep the Conversation Going Rethink Your LUPUS Story be ... · By providing your name, address, email address, and other information, you certify that you are at least 18 years old

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.

Page 9: Keep the Conversation Going Rethink Your LUPUS Story be ... · By providing your name, address, email address, and other information, you certify that you are at least 18 years old

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.

Page 10: Keep the Conversation Going Rethink Your LUPUS Story be ... · By providing your name, address, email address, and other information, you certify that you are at least 18 years old

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.

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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.

Page 11: Keep the Conversation Going Rethink Your LUPUS Story be ... · By providing your name, address, email address, and other information, you certify that you are at least 18 years old

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

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ay be pregnant.

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Page 12: Keep the Conversation Going Rethink Your LUPUS Story be ... · By providing your name, address, email address, and other information, you certify that you are at least 18 years old

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