I n f o r m a t io n f o r P a t ie n f s A b o u t
EVISTA®
(raloxifene hydrochloride)
T a b le t s f o r Oral Use
P lease read th e in fo rm a tio n c a re fu lly th a t c o m e s w ith E V IS T A
before you start taking it and each tim e you refill your prescription.
T h e in fo rm a tio n m a y h ave c h a n g e d . T h is in fo rm a tio n d o e s n o t
ta k e th e p lace o f ta lk in g w ith y o u r d o c to r a b o u t y o u r m e d ic a l
condition o r treatm en t. Talk w ith y o u r d octor about E V IS TA w h e n
y o u s ta rt ta k in g it a n d at re g u la r c h e c k u p s .
W h a t is th e m o s t im p o rta n t
in fo rm a tio n I s h o u ld k n o w a b o u t E V IS TA ?
S e rio u s a n d life -th r e a te n in g s id e e ffe c ts can o c c u r w h ile
ta k in g E V IS T A . T h e s e in c lu d e b lo o d clo ts a n d dying fr o m stroke:
•
In c r e a s e d
ris k o f b lo o d c lo ts in th e le g s ( d e e p v e in
th ro m b o s is ) a n d lu n g s (p u lm o n a ry e m b o lis m ) have been
reported w ith E VIS TA . W o m e n w h o have or have had blood
clots in th e leg s, lu n g s, o r ey e s s h o u ld n o t ta k e E V IS T A .
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W o m e n w h o h a v e h ad a h e a rt a tta c k o r are at risk fo r a
h e a rt a tta c k m a y h a v e a n in c re a s e d risk o f d y in g fr o m
stroke w h e n taking E V IS T A .
1
. B efo re s ta rtin g E V IS T A . tell y o u r d o c to r if y o u h a v e had
blood clots in y o u r legs, lungs, o r eyes, a stroke, m in i-s tro k e
(tra n s ie n t is c h e m ic a tta c k ), o r h ave an irre g u la r h e a rtb e a t.
2
. S to p ta k in g E V IS T A a n d call y o u r d o c to r if you have:
• leg pain o r a feelin g o f w a r m th in th e lo w e r leg (calf).
• sw ellin g o f th e legs, h a n d s , o r feet.
• s u d d e n c h e s t p a in , s h o r tn e s s o f b re a th , o r c o u g h in g
u p b lo o d .
•s u d d e n c h a n g e in y o u r visio n , s u c h as loss of v isio n o r
blurred visio n .
3
. Being still fo r a lo n g tim e (s u c h as sitting still d u rin g a long
c a r o r a ir p la n e tr ip o r b e in g in b e d a fte r s u r g e r y ) c a n
in c re a s e y o u r ris k o f b lo o d c lo ts .
(S e e “ W h a t s h o u ld
I a v o id if I a m ta k in g E V IS T A ? ” )
W h a t is E V IS T A ?
E V IS T A is a ty p e of p re s c rip tio n m e d ic in e called a S elective
E s tro g e n R e c e p to r M o d u la to r (S E R M ). E V IS T A is fo r w o m e n
a fte r m e n o p a u s e , a n d h a s m o re th a n o n e use:
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O s te o p o ro s is : E V IS T A tre a ts an d p re v e n ts o s te o p o ro s is by
h elping m a k e y o u r b o n e s s tro n g e r a n d less likely to b reak.
•
In v a s iv e B re a s t C a n c e r: If y o u h ave o s te o p o ro s is o r a re at
high risk fo r b re a s t cancer, E V IS T A c a n be used to lo w e r
y o u r c h a n c e of g e ttin g in vasive b re a s t cancer. E V IS T A w ill
n o t to ta lly g e t rid of y o u r c h a n c e o f g etting b re a s t cancer.
Y o u r d o c to r c a n e s tim a te y o u r ris k o f b re a s t c a n c e r b y
askin g y o u a b o u t risk fa c to rs , includ ing :
• y o u r a g e (g e ttin g o ld e r).
• f a m ily h is to ry o f b re a s t c a n c e r in y o u r m o th e r, sister,
o r d aug h ter.
• a h is to ry o f a n y b re a s t b io p s y , e s p e c ia lly an a b n o rm a l
biopsy.
E V IS T A ® (ra lo x ife n e h y d ro c h lo rid e )
P V
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A M P
Y o u an d y o u r d o c to r s h o u ld ta lk a b o u t w h e th e r th e p ossib le
b e n e fit of E V IS T A in lo w e rin g y o u r c h a n c e o f g e ttin g invasive
b re a s t c a n c e r is g re a te r th a n its p o s s ib le risks.
E V IS T A is n o t fo r use in p re m e n o p a u s a l w o m e n (w o m e n w h o
h ave n o t p a s s e d m e n o p a u s e ).
W h o s h o u ld n o t ta k e E V IS T A ?
D o n o t take E V IS T A if you:
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h ave o r h a v e had b lo o d clo ts in y o u r legs, lu n g s , o r eyes.
Takin g E V IS T A m a y in c re a s e th e risk o f g e ttin g b lo o d clots.
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a re p r e g n a n t o r c o u ld b e c o m e p re g n a n t. E V IS T A c o u ld
h a rm y o u r u n b o rn child.
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a re n u rs in g a baby. It is n o t k n o w n if E V IS T A p asses into
b re a s t m ilk o r w h a t e ffe c t it m ig h t h ave o n th e baby.
W h a t s h o u ld I te ll m y d o c to r b e fo re ta k in g E V IS T A ?
E V IS T A m a y n o t be rig h t fo r y o u . B e fo re ta k in g E V IS T A . tell
y o u r d o c to r a b o u t all y o u r m e d ic a l c o n d itio n s , in c lu d in g if you:
•
h ave had blood clo ts in y o u r legs, lu n g s, o r eyes, a stroke,
m in i-s tr o k e (T IA /tra n s ie n t is c h e m ic a tta c k ), o r a ty p e o f
irre g u la r h e a rtb e a t (atrial fib rilla tio n ).
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h ave had b reast cancer. E V IS T A has n o t b een fu lly studied
in w o m e n w h o h ave a h is to ry o f b re a s t cancer.
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h ave liver o r kid n ey p ro b le m s .
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h ave ta k e n e s tro g e n in th e p a s t a n d had a h ig h increase
of trig ly c e rid e s (a kind of fat in th e b lo o d ).
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a re p re g n a n t, p la n n in g to b e c o m e p re g n a n t, o r b re a s t-
fe e d in g (s e e “ W h o s h o u ld n o t ta k e E V IS T A ? ” ).
Tell y o u r d o c to r a b o u t all m e d ic in e s y o u ta k e , in c lu d in g
p re s c rip tio n a n d n o n -p r e s c r ip tio n m e d ic in e s , v ita m in s , a n d
h erb al s u p p le m e n ts . K n o w th e m e d ic in e s y o u take. K eep a list
of th e m an d s h o w it to y o u r d o c to r a n d p h a rm a c is t each tim e
y o u g e t a n e w m e d ic in e . E sp ecially tell y o u r d o c to r if y o u ta k e *:
•
w a rfa rin (C o u m a d in ® , J a n to v e n ® )
If you are taking w a rfa rin o r o th er c o u m a rin blood thinners,
y o u r d o c to r m a y need to d o a b lo o d te s t w h e n you firs t
s ta rt o r if y o u n e e d to s to p ta k in g E V IS T A . N a m e s for th is
te s t in c lu d e “p r o th r o m b in t i m e ,” “ p r o - t im e ,” o r “IN R .”
Y o u r d o c to r m a y n e e d to a d ju s t th e d o s e o f y o u r w a rfa rin
o r o th e r c o u m a rin b lo o d th in n er.
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c h o le s ty ra m in e
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e s tro g e n s
E V IS T A sh ould not be taken w ith c h o le s ty ra m in e o r estrogens.
H o w s h o u ld I ta k e E V IS T A ?
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Take E V IS T A exactly h o w y o u r d o c to r tells y o u to.
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K eep ta k in g E V IS T A fo r as lo n g as y o u r d o c to r p rescrib es
it f o r y o u . It is n o t k n o w n h o w lo n g y o u s h o u ld k e e p
ta k in g E V IS T A to lo w e r y o u r c h a n c e o f g e ttin g in v a s iv e
b re a s t can cers.
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It is im p o rta n t to g e t y o u r refills on tim e so y o u d o not run
o u t o f th e m e d ic in e .
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Take o n e E V IS T A ta b le t each day.
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Take E V IS T A at a n y tim e o f th e day, w ith o r w ith o u t food.
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To help y o u re m e m b e r to ta k e E V IS T A , it m a y be best to
ta k e it at a b o u t th e s a m e tim e each day.
E V IS T A ® (ra lo x ife n e h y d ro c h lo rid e )
P V
3 1 2 4
A M P