Information for Patients About
EVISTA®
(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 treatment. Talk with 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 (pulmonary embolism) have been reported with
EVISTA. Women who have or have had blood clots in the
legs, lungs, or eyes should not take EVISTA.
•Women 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
blood clots in your legs, lungs, or eyes, a stroke,
m ini-stroke (transient ischemic attack), or have an
irregular heartbeat.
2. Stop taking EVISTA and call your doctor if you have:
• leg pain or a feeling of warmth in the lower leg (calf).
• swelling of the legs, hands, or feet.
•sudden 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 time (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 Modulator (SERM). EVISTA is for 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 estimate your risk of breast cancer by
asking you about risk factors, including:
•yourage (getting older).
•fam ily history of breast cancer in your mother, 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.
•are pregnant or could become pregnant. EVISTA could
harm your unborn child.
•are nursing a baby. It is not known if EVISTA passes into
breast milk or what effect it might 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,
mini-stroke (TIA/transient ischemic 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 medicines you take, including
prescription and non-prescription medicines, vitamins, 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*:
•warfarin (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 “prothrombin time,” “pro-time,” 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 important to get your refills on time so you do not run
out of the medicine.
• Take one EVISTA tablet each day.
• Take EVISTA at any time of the day, with or without food.
•To help you remember to take EVISTA, it may be best to
take it at about the same time each day.
EVISTA® (raloxifene hydrochloride tablets)
PV 3125 AMP
