Information for Patients About
E V I S T A ®
(raloxifene hydrochloride tablets)
Tablets for Oral Use
Please read the information carefully that comes with EVISTA
before you start taking it and each time you refill your prescription.
The information
may have changed. This information does not
take the
place of talking with your doctor about your medical
condition
or treatm ent.
Talk w ith
your doctor about
EVISTA
when you start taking it and at regular checkups.
What is the most important
information I should know about EVISTA?
Serious and life-threatening side effects can occur while taking
EVISTA. These include blood clots and dying from stroke:
• Increased risk of blood clots in the legs (deep vein thrombosis)
and
lungs (pulm onary em bolism)
have
been
reported with
EVISTA.
Women who
have or have
had
blood
clots
in the
legs, lungs, or eyes should not take EVISTA.
•W om en
who
have
had
a
heart attack or are at
risk for a
heart attack
may
have
an
increased
risk
of
dying
from
stroke when taking EVISTA.
1. Before
starting
EVISTA, tell your doctor if you
have
had
b lo o d
c lo ts
in
y o u r
legs,
lu n g s ,
o r
eyes,
a
s tro k e ,
m in i-s tro k e
(tra n s ie n t
isch e m ic
a tta ck),
o r
have
an
irregular heartbeat.
2. Stop taking EVISTA and call your doctor if you have:
• leg pain or a feeling of warm th in the lower leg (calf).
• swelling of the legs, hands, or feet.
•su d d e n
chest
pain,
shortness
of
breath,
or coughing
up blood.
• sudden
change in your vision,
such as loss of vision
or
blurred vision.
3. Being still for a long tim e (such as sitting still during a long
car
or airplane trip
or
being
in
bed
after surgery)
can
increase
your
risk
of
blood
clots.
(See
“What should
I avoid if I am taking EVISTA?”)
What is EVISTA?
EVISTA is a type of prescription
medicine called a Selective
Estrogen
Receptor
M odulator
(SERM).
EVISTA
is fo r women
after menopause, and has more than one use:
• Osteoporosis:
EVISTA treats and
prevents osteoporosis by
helping make your bones stronger and less likely to break.
• Invasive Breast Cancer:
If you have osteoporosis or are at
high
risk for
breast cancer,
EVISTA can
be
used to
lower
your chance of getting
invasive
breast cancer.
EVISTA will
not totally get rid of your chance of getting
breast cancer.
Your doctor can
estim ate your
risk
of
breast
cancer
by
asking you about risk factors, including:
•yo u ra g e (getting older).
•fa m ily
history
of
breast cancer
in
your
m other,
sister,
or daughter.
• a history of any breast biopsy, especially an abnormal biopsy.
EVISTA® (raloxifene hydrochloride tablets)
PV 3125 AMP
You and your doctor should talk about whether the possible
benefit of EVISTA in lowering your chance of getting invasive
breast cancer is greater than its possible risks.
EVISTA is
not for use
in
premenopausal women
(women who
have not passed menopause).
Who should not take EVISTA?
Do not take EVISTA if you:
•have or have had
blood
clots in your legs,
lungs,
or eyes.
Taking EVISTA may increase the risk of getting blood clots.
•a re
pregnant
or could
become
pregnant.
EVISTA could
harm your unborn child.
•a re
nursing a
baby.
It
is
not known
if
EVISTA passes
into
breast m ilk or what effect it m ight have on the baby.
What should I tell my doctor before taking EVISTA?
EVISTA may not be right for you.
Before taking
EVISTA, tell
your doctor about all your medical conditions, including if you:
• have had blood clots in your legs, lungs, or eyes, a stroke,
m ini-stroke
(TIA/transient
ischem ic
attack),
or a type
of
irregular heartbeat (atrial fibrillation).
• have had
breast cancer.
EVISTA has not been fully studied
in women who have a history of breast cancer.
• have liver or kidney problems.
• have taken estrogen in the past and had a high increase of
triglycerides (a kind of fat in the blood).
•are pregnant, planning to become pregnant, or breast-feeding
(see
“Who should not take EVISTA?”).
Tell
your
doctor about all
m edicines you
take,
including
prescription
and
non-prescription
m edicines,
vitam ins,
and
herbal supplements.
Know the
medicines you take.
Keep a list
of them and show it to your doctor and
pharmacist each time
you get a new medicine. Especially tell your doctor if you take*:
•w arfarin (Coumadin®, Jantoven®)
If you are taking warfarin or other coumarin blood thinners,
your doctor
may
need to
do a
blood test when you first
start or if you need to stop taking EVISTA.
Names for this
test
include
“ prothrom bin
tim e ,”
“ p ro -tim e ,”
or
“ INR.”
Your doctor may need to adjust the dose of your warfarin
or other coumarin blood thinner.
• cholestyramine
• estrogens
EVISTA should not be taken with cholestyramine or estrogens.
How should I take EVISTA?
• Take EVISTA exactly how your doctor tells you to.
• Keep taking EVISTA for as long as your doctor prescribes it for
you. It is not known how long you should keep taking EVISTA
to lower your chance of getting invasive breast cancers.
• It is im portant to get your refills on tim e so you do not run
out of the medicine.
• Take one EVISTA tablet each day.
• Take EVISTA at any tim e of the day, with or w ithout food.
•T o
help you
remember to take
EVISTA,
it
may
be
best to
take it at about the same tim e each day.
EVISTA® (raloxifene hydrochloride tablets)
PV 3125 AMP
