EVISTA® (raloxifene HCl) | Healthy Living

EVISTA is indicated for the prevention and treatment of osteoporosis in postmenopausal women and for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer.

Important limitations of use for breast cancer risk reduction are as follows: There are no data available regarding the effect of EVISTA on invasive breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of EVISTA. EVISTA is not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence. EVISTA is not indicated for the reduction in the risk of noninvasive breast cancer.

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Important Safety Information for EVISTA^® (raloxifene HCl tablets)

WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE
Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA. Women with active or past history of venous thromboembolism should not take EVISTA. Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke.

Contraindications

EVISTA is contraindicated in nursing women and in women who are or may become pregnant, as it may cause fetal harm. EVISTA is also contraindicated in women with active or past venous thromboembolic events (VTEs), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.

Warnings and Precautions

In a study of postmenopausal women at high risk for cardiovascular disease taking EVISTA, there was no increase in the incidence of stroke; however, there was an increase in death due to stroke. EVISTA also did not increase or decrease the incidence of overall mortality, cardiovascular mortality, or heart attack. The risk-benefit balance should be considered in women at risk for stroke, such as those with prior stroke or transient ischemic attack (TIA), atrial fibrillation, hypertension, or cigarette smoking.
EVISTA should be used with caution in patients with hepatic impairment or moderate/ severe renal impairment since safety and efficacy have not been established in these patients.
The safety of concomitant use of EVISTA with systemic estrogens has not been established and its use is not recommended.

Adverse Reactions

The common adverse reactions considered to be drug related:

Adverse reactions occurring in the clinical trials at a frequency ≥2.0% in either group and in more EVISTA-treated women than in placebo-treated women include:

The majority of adverse reactions occurring during the osteoporosis prevention and treatment studies were mild and generally did not require discontinuation of therapy.

For additional information, please see the full Prescribing Information and Medication Guide.

EVISTA is a once-daily 60-mg tablet. Supplemental calcium and/or vitamin D should be added to diet if daily intake is inadequate.

EVISTA is indicated for the treatment of osteoporosis and for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.

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.

Please read the safety information provided on this page. To enter the EVISTA Web site, click the button below.

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. You should only take prescription EVISTA if you are past menopause. Before taking EVISTA, talk to your doctor about all your medical conditions. If you are pregnant, nursing or may become pregnant, do not take EVISTA, as it may cause fetal harm. 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. 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 www.fda.gov/medwatch, or call 1-800-FDA-1088.

For more safety information, please see the Medication Guide and full Prescribing Information.

Healthy Living

By making a few basic lifestyle changes, you may help reduce your risk for osteoporosis and invasive breast cancer. One step alone isn't enough, but taken together these recommended lifestyle changes may make a significant difference for your health.

Nutrition: Get daily recommended amounts of calcium and vitamin D
Exercise: Engage in regular weight-bearing exercise
Healthy Habits: Avoid smoking and excessive alcohol
Medications: Avoid or substitute medications that may cause bone loss

Nutrition
Thinking about the way you eat is important, and now is the time to review your diet and eating habits. By choosing a variety of foods from each of the basic food groups, you can not only maintain a healthy weight, you can be sure your body is getting the nutrients it needs at this stage of your life to help keep your bones strong. According to the American Cancer Society, eating a diet of five or more servings of fruits and vegetables each day can help keep you healthy.

Calcium: Research shows that not getting enough calcium is associated with low bone mass, rapid bone loss, and high fracture rates. Over the age of 50, women should get at least 1,200 mg of calcium every day. Foods that are relatively high in calcium include:

low-fat dairy products, such as milk, yogurt, cheese, and ice cream
dark green, leafy vegetables, such as broccoli, collard greens, bok choy, and spinach
fish, such as sardines and salmon
foods fortified with calcium, such as orange juice, cereals, and breads
tofu
almonds

If you don't get enough calcium each day from your food, you may need to take a calcium supplement.

Vitamin D: Vitamin D helps your body absorb calcium. Your body makes vitamin D in response to sunlight. Adequate levels of vitamin D may be lower in the elderly, the housebound, and in some people during the winter (such as in cloudy, northern climates). A daily intake of 800-1000 IU per day of vitamin D for women over 50 is recommended. Good sources of vitamin D include:

vitamin D-fortified dairy products and cereals
egg yolks
saltwater fish
liver

If you do not get enough of these nutrients in your diet, many calcium and vitamin D supplements are available. They are best taken in a split dose with food to aid absorption.

Exercise
Exercise for weight control is an important risk reduction tool as you age.

Weight-bearing exercise, such as walking, may help protect your bones and provide other health benefits. Exercise also helps maintain flexibility and balance, reducing your risk of falls and fractures. Other types of weight-bearing exercise include anything that gets your heart rate up, such as jogging, low-impact aerobics, stair-climbing, tennis, and dancing
Resistance exercise (weight training) can help build muscle to protect bones from fractures

Before beginning any new exercise program, check with your healthcare professional, particularly if you have osteoporosis.

Healthy Habits

Quit Smoking: Smoking is not only bad for your heart and lung health, but bad for your bone health as well. Research shows that smokers also may absorb less calcium from their diets. If you smoke and have thought about quitting, now is the time to take charge.

Reduce Alcohol: Research has shown that more than 2 drinks each day of alcohol may lead to greater bone loss. Those who drink heavily are also more prone to fractures due to both poor nutrition and an increased risk of falling. Women who have 2 to 5 drinks daily have about 1½ times the breast cancer risk of women who drink no alcohol.

Talk with your healthcare professional to better understand health risks related to alcohol consumption.

Certain Medications
Certain medications when taken for a long time may lead to bone loss and possible fractures. These medications include:

Glucocorticoids, which are prescribed for diseases like arthritis, asthma, Crohn's disease, lupus, and other diseases of the lungs, kidneys, and liver
Certain antiseizure drugs, such as phenytoin (Dilantin^®*) and other barbiturates
Gonadotropin-releasing hormone (GnRH) analogs used to treat endometriosis
Excessive aluminum-containing antacids
Certain cancer treatments (ask your healthcare professional)
Excessive thyroid hormone

If you are taking or think you may by taking these drugs, please discuss the implications for your bone health with your healthcare professional. Do not stop or alter your medication dose on your own. Make sure to tell your healthcare professional about all the drugs you are taking.

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