Indications for EVISTA® (raloxifene HCl tablets)
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 strong and less likely to break. EVISTA can be taken with calcium and vitamin D
as recommended by your healthcare provider.
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, such as: your age (getting older); family history of breast cancer in your mother, sister, or daughter; a history
of any breast biopsy, especially an abnormal biopsy. 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.
If you already have or have had breast cancer, EVISTA does not treat it or prevent
its return, and it does not reduce the risk of all forms of breast cancer.
Important Safety Information about EVISTA® (raloxifene HCl tablets)
What is the most important information I should know about EVISTA?
You should not take EVISTA if you have had or are at risk for getting blood clots in the legs, lungs or eyes,
as it may increase the risk of blood clots. Stop taking EVISTA and call your doctor if you have leg pain or warmth,
swelling of the legs, hands or feet, chest pain, shortness of breath or a sudden vision change, as these may be signs
of a blood clot. Being unable to move around for long periods may increase this risk. If you will need to be still for a
long time, talk to your doctor about ways to reduce the risk of blood clots.
EVISTA does not increase the risk of a heart attack or stroke in women who have had or are at risk for a heart attack;
however; EVISTA increases the likelihood of dying from stroke in these women, should one occur. Before taking EVISTA tell
your doctor if you have had a stroke, a mini-stroke, irregular heartbeat, high blood pressure, heart attack, history of smoking,
or believe you have other risk factors for stroke or a heart attack.
EVISTA is not right for everyone. Do not take EVISTA if you:
- have had blood clots in your legs, lungs or eyes.
- are pregnant, nursing or may become pregnant, as EVISTA may cause fetal harm.
What should I tell my doctor before taking EVISTA?
Talk to your doctor about all your medical conditions including:
- If you have had blood clots in your legs, lungs or eyes.
- If you have had a stroke, mini-stroke, irregular heartbeat, high blood pressure, heart attack, history of smoking, or think you have other risk factors for stroke or heart attack.
- EVISTA should not be used for prevention of heart disease.
- If you are premenopausal. Only take prescription EVISTA if you are past menopause.
- If you have liver or kidney disease. Women with liver or kidney disease should use EVISTA with caution.
- EVISTA should not be taken with estrogens in the form of pills, patches or injections.
- If you have taken estrogen in the past and had a high increase of triglycerides (a kind of fat in the blood).
What are the possible side effects of EVISTA?
- Side effects may include hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088.
What are the possible drug interactions with EVISTA?
- If you take warfarin (Coumadin®, Jantoven®) or other coumarin blood thinners, you may need to do a blood
test (prothrombin time, pro-time or INR) when you first start or if you need to stop taking EVISTA. Your doctor may need to adjust the
dose of your warfarin or other coumarin blood thinners.
- EVISTA should not be taken with cholestyramine or estrogens.
See Full Prescribing Information and Medication Guide, including Boxed Warning for increased risk of blood clots and death from stroke.
RA ISI CON 28Sept2011