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EVISTA is not right for everyone. 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.
- Before starting EVISTA, tell your doctor if you have had blood clots in your legs, lungs, or eyes, a stroke, mini-stroke (transient ischemic attack), have an irregular heartbeat, high blood pressure, or smoke cigarettes.
Common Side Effects of EVISTA
Signs of Blood Clots
Questions or Concerns
Common Side Effects of EVISTA
Hot flashes, leg cramps, swelling of the feet, ankles, and legs, flu syndrome, joint pain, and sweating are common side effects
that have been reported by women past menopause taking EVISTA. Hot flashes are more common during the first 6 months after starting treatment.
Signs of Blood Clots
Stop taking EVISTA and call your doctor and/or seek emergency medical treatments if you have or have had any of these symptoms, which may be signs of a blood clot:
- Leg pain or warmth in the lower leg (calf)
- Swelling of the legs, hands or feet
- Sudden chest pain
- Shortness of breath or coughing up blood
- Sudden vision change, such as loss or blurred vision
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 when taking EVISTA.
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Questions or Concerns
These are not all the side effects of EVISTA. Tell your doctor about any side effect that bothers you or that does not go away.
If you have any problems or questions that concern you while taking EVISTA, ask your doctor or pharmacist for more information.
Stop taking EVISTA at least 3 days before a planned surgery or before you plan on being still for a long time.
EVISTA has not been found to cause breast tenderness or enlargement. If you notice any changes in your breasts, call your doctor to
find out the cause. Before starting and while taking EVISTA you should have breast exams and mammograms, as directed by your doctor.
Because EVISTA does not eliminate the chance of developing breast cancers, you need these examinations to find any breast cancers as
early as possible.
EVISTA should not cause spotting or menstrual-type bleeding. If you have any vaginal bleeding, call your doctor to find out the cause.
EVISTA has not been found to increase the risk for cancer of the lining of the uterus.
For more safety information about EVISTA, and important information for individuals taking EVISTA, see the
Medication Guide and
full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
,
or call 1-800-FDA-1088.
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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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