M E D IC A T IO N G U ID E
V Y V A N S E ™
(lis d e x a m fe ta m in e d im e s y la te )
C ll
Read the M edication Guide th a t com es w ith Vyvanse before you or your child starts
taking it and each tim e you get a refill. There m ay be new in fo rm a tio n. This
M edication Guide does not take the place o f talking to y o u r doctor about you or yo u r
c h ild ’s treatm ent w ith Vyvanse.
W hat is the m o st im p o rta n t in fo rm a tio n I should kn o w about V yvanse?
Vyvanse is a s tim u la n t m e d ic in e . The fo llo w in g have been re p o rte d w ith use
of s tim u la n t m e d ic in e s .
1 .
H e a rt-re la te d p ro b le m s :
•
sudden death in p a tie n ts w ho have h e a rt p ro b le m s or h e a rt defects
•
stroke and h e a rt a tta ck in a d u lts
•
increased blood p ressure and heart rate
Tell your d o cto r if you o r yo u r ch ild have any heart problem s, heart defects, high
blood pressure, or a fa m ily h isto ry o f these problem s.
Y our d o c to r should check you o r y o u r child carefully fo r heart p roblem s before
starting Vyvanse.
Y our d o cto r should check you o r y o u r ch ild 's blood pressure and heart rate
regularly d uring treatm ent w ith Vyvanse.
C all your d o cto r rig h t aw ay if you or your c h ild has any signs of h e a rt p ro b le m s
such as chest p a in , sh o rtn e ss of b reath, or fa in tin g w h ile ta k in g V yvanse.
2 .
M ental (Psy c h ia tric ) p ro b le m s :
A ll P atients
•
new or w orse b e h a vio r and th o u g h t p ro b le m s
•
new or w orse b ip o la r illn e s s
•
new or w orse a g g re ssive b e h a v io r or h o s tility
C hildren and Teenagers
•
new p sych o tic sym p to m s (such as h e a rin g v o ice s, b e lie v in g th in g s that
are not tru e , a re su s p ic io u s ) or new m a n ic sym ptom s
Tell your d o cto r about any m ental problem s you or yo u r child have, or a b out a
fa m ily h isto ry o f suicide, b ip o la r illness, o r depression.
C all your d o cto r rig h t aw a y it you or yo u r c h ild have any new o r w o rse n in g
m ental s ym p to m s or p ro b le m s w h ile ta k in g V yvanse, e s p e c ia lly seeing or
hearing th in g s th a t are n o t re a l, b e lie v in g th in g s th a t are not re a l, or are
su sp icio u s.
W h a t Is Vyvanse?
Vyvanse is a central nervous system stim u la n t pre scrip tio n m edicine. It is used fo r
the tre a tm e n t o f A tte n tio n -D e fic it H y p e ra c tiv ity D iso rd e r (A D H D ). Vyvanse m ay
help increase attention and decrease im pulsiveness and hype a ctivity in patients w ith
ADHD.
Vyvanse should be used as a part o f a total treatm ent program fo r ADHD that m ay
include counseling or o th e r therapies.
Vyvanse is a fe d e ra lly c o n tro lle d substance (C ll) because it can be abused or
lead to d e p e n d e n ce . Keep V yvanse in a sa fe place to p re ve n t m isu se and
abuse. S e llin g or g iv in g aw ay V yvanse m ay harm others, and is a g a in s t the
law .
Tell your d o cto r if you o r yo u r child have (or have a fam ily history of) ever abused
o r been dependent on alcohol, prescription m edicines or street drugs.
W ho should not take Vyvanse?
Vyvanse sh o u ld not be taken if you or your c h ild :
•
have heart disease or hardening o f the arteries
•
have m oderate to severe high blood pressure
•
have h yperthyroidism
•
have an eye problem called glaucom a
•
are very anxious, tense, or agitated
•
have a h isto ry uf drug abuse
•
are taking or have taken w ith in the past 14 days an anti-depression m edicine
called a m onoam ine oxidase in h ib ito r o r M AOI.
•
is sensitive to. allergic to, or had a reaction to other stim ulant m edicines
Vyvanse has not been studied in children less than 6 years old.
Vyvanse is not
recom m ended fo r use in children less than 3 years old.
Vyvanse m ay not be rig h t to r you or yo u r c h ild . B efore sta rtin g V yvanse te ll your
or your c h ild ’s d o cto r a b out a ll h e a lth co n d itio n s (o r a fa m ily h is to ry o f) in c lu d in g :
•
heart pro b le m s, heart defects, high blood pressure
•
mental problem s inclu d in g psychosis, m ania, bipolar illness, o r depression
•
tics o r Tourette’s syndrom e
•
liver o r kidney problem s
•
thyroid problem s
•
seizures o r have had an abnorm al brain w ave test (EEG)
Tell your d o c to r if you o r y o u r child is pregnant, planning to becom e pregnant, or
breastfeeding.
Can V yvanse be ta ke n w ith o th e r m e d icin e s?
T ell y o u r d o cto r a b out a ll o f the m e d ic in e s th a t you or yo u r c h ild take in c lu d in g
p re s c rip tio n and n o n p re scrip tio n m e d ic in e s , v ita m in s , and h erbal s u p p le m e n ts.
Vyvanse and som e m edicines m ay interact w ith each other and cause serious side
effects. S om etim es the doses of o th e r m edicines w ill need to be adjusted w hile
taking Vyvanse.
Y our d o cto r w ill decide v/hether Vyvanse can be taken w ith other m edicines.
E sp e cia lly te ll y o u r doctor if you o r yo u r c h ild takes:
•
anti-depression m edicines including M AOIs
•
a n ti-p sych o tic m edicines
•
lith iu m
•
blood pressure m edicines
•
seizure m edicines
•
narcotic pain m edicines
K now the m edicines th a t you or yo u r child takes. Keep a list o f y o u r m edicines w ith
you to sh o w yo u r d o c to r and pharm acist.
Do not s ta rt any new m e d icin e w h ile ta kin g V yvanse w ith o u t ta lk in g to your
d o c to r firs t.
H ow sh o u ld V yvanse be taken?
•
Take V yvanse e xa ctly as p re s c rib e d . Vyvanse com es in 6 d iffe re n t strength
capsules. Your d o cto r may adjust the dose until it is rig h t fo r you o r yo u r child.
•
Take Vyvanse once a day in the m orning.
•
Vyvanse can he taken w ith o r w ith o u t food.
•
From tim e to tim e , y o u ' d o c to r m ay stop Vyvanse tre a tm e n t fo r a w hile to check
ADHD sym ptom s.
•
Your do cto r m ay do regular checks of the blood, heart, and blood pressure w hile
taking Vyvanse. C hildren should have th e ir height and w e ig h t checked often w hile
taking Vyvanse. Vyvanse tre a tm e n t m ay be stopped if a problem is fo und d uring
these check-ups.
•
If you o r yo u r c h ild takes too m uch V yvanse or o ve rd o se s, c a ll y o u r d o c to r or
poison co n tro l ce n te r rig h t aw ay, or get em e rg e ncy tre a tm e n t.
W h a t a re p o s s ib le sid e effects o f Vyvanse?
See “ W h a t is the m ost im p o rta n t in fo rm a tio n I should know a b o u t V yvanse?”
to r in fo rm a tio n on reported heart and m ental problem s.
O ther s e rio u s sid e e ffects in clu d e :
•
slo w in g o f g ro w th (height and w eight) in children
•
seizures, m ainly in patients w ith a h is to ry o f seizures
•
eyesight changes o r blurred vision
C om m on sid e e ffe cts include:
•
upper belly pain
• nausea
• d ry m outh
•
dizziness
• w e ig h t loss
• tro u b le sleeping
•
irrita b ility
• decreased appetite
• vo m itin g
Vyvanse m ay affect yo u r o r y o u r c h ild ’s a b ility to drive or do other dangerous
activities.
Talk to yo u r d o c to r if you or yo u r child has side effects th a t are bothersom e o r do not
go away.
T his is not a com plete list o f possible side effects. Ask y o u r do cto r or p harm acist fo r
m ore in fo rm a tio n.
H ow sh o u ld I store Vyvanse?
•
S tore Vyvanse in a safe place at room tem perature, 59 to 86° F (15 to 3 0 ° C).
P rotect fro m light.
•
Keep V yvanse and a ll m e d icin e s out of th e reach of c h ild re n .
G eneral in fo rm a tio n about Vyvanse
M edicines are som etim es prescribed (or purposes other than those listed in a
M edication
Guide. Do not use Vyvanse fo r a co n d itio n fo r w h ich it w as not
prescribed. Do not give Vyvanse to o th e r people, even if th e y have the sam e
co n d ition . It m ay harm them and it is against the law.
T his M edication Guide sum m arizes the m o st im p o rta n t info rm a tio n about Vyvanse. If
you w ould like m ore inform ation, talk w ith yo u r doctor. You can ask y o u r d o c to r or
p h a rm a c is t
fo r
in fo rm a tio n
a b o u t
V yvanse
th a t
w as
w ritte n
fo r
healthcare
professionals. For m ore inform ation about Vyvanse. please contact Shire US Inc. at
1-800-828-2088.
W h a t a re the in g re d ie n ts in Vyvanse?
A ctive In g re d ie n t: lisdexam fetam ine dim esylate
In a c tiv e
In g re d ie n ts :
m ic ro c ry s ta llin e
ce llu lo se ,
cro sca rm e llo se
s o d iu m ,
and
m agnesium stearate. The capsule shells contain gelatin, tita n iu m dioxide, and one or
m ore o f the fo llo w in g :
D&C
Red #28. D&C Yellow #10. FD&C Blue #1. FD&C Green
#3. and FD&C Red #40.
T h is
M e d ic a tio n
G uide h as
been
a p p ro v e d
by th e
U .S .
Food
and
D rug
A d m in is tra tio n .
© 2 0 0 8 S hire US Inc.
Last M odified: 0 4 /23/2008
LDXM G3
04/08
«-'Shire
