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EVISTA is an osteoporosis medicine for women past menopause that is also shown to help reduce the risk of invasive breast cancer.
EVISTA is a type of prescription medicine called an estrogen agonist/antagonist, commonly called a Selective Estrogen Receptor Modulator (SERM). This means it works 2 ways in your body. EVISTA acts like estrogen in some tissues, and blocks the effect of estrogen in other tissues:
- in your bones, EVISTA appears to mimic the effect of estrogen
- in your breasts, EVISTA blocks the effect of estrogen
Helps Protect Your Breasts
In clinical studies of women past menopause with osteoporosis, EVISTA was shown to reduce the risk of invasive breast cancer by 71% (absolute risk reduction 1.1%) after 4 years and by 56% (absolute risk reduction 0.9%) during an additional 4 years of observation, in women past menopause with osteoporosis.
In a subset of 2,641 women who participated in the above 2 trials and were followed for up to 8 years, EVISTA reduced the risk of invasive breast cancer by 60% and 1.5% absolute risk reduction.
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.
Helps Protect Your Bones
EVISTA has been prescribed by healthcare professionals for more than 10 years to:
- Help make bones stronger
- Help stop thinning of the bone
- Increase bone mineral density
- Reduce the risk of spine fractures
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Indication for EVISTA® (raloxifene HCI tablets)
EVISTA treats osteoporosis in women past menopause and lowers the chance of getting invasive breast cancer. EVISTA will not totally get rid of your chance of getting breast cancer.
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.
EVISTA can be taken with calcium and vitamin D.
Indication for EVISTA® (raloxifene HCI tablets)
EVISTA treats and prevents osteoporosis in women past menopause.
Indication for EVISTA® (raloxifene HCI tablets)
EVISTA can be used to lower your chance of getting invasive breast cancer in women past menopause at high risk for 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.
Indications for EVISTA® (raloxifene HCI 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. 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)
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
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