EVISTA® (raloxifene HCl) | Frequently Asked Questions

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.

Frequently Asked Questions

You may have many questions about EVISTA, such as how it works, how and when to take it, interactions with other drugs, and more.

1. What is EVISTA?
EVISTA is a type of prescription medicine called an estrogen agonist/antagonist, commonly called a Selective Estrogen Receptor Modulator (SERM). EVISTA is for women after menopause, and has more than one use: EVISTA treats osteoporosis by helping make your bones stronger and less likely to break; and if you have osteoporosis or are at high risk for invasive 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 spinal fractures or invasive breast cancer.

2. Is EVISTA an estrogen or hormone?
EVISTA is NOT a hormone, like estrogen. It's called an estrogen agonist/antagonist, which means it works 2 ways in your body. EVISTA acts like estrogen in some tissue, and has the opposite effect of estrogen in other tissues.

In your bones, EVISTA appears to mimic the effect of estrogen
In your breasts, EVISTA appears to block the effect of estrogen

3. Can EVISTA treat osteoporosis?
EVISTA treats osteoporosis in women after menopause by helping to make bones stronger and less likely to break.

4. Can EVISTA reduce the risk of invasive breast cancer?
If you have osteoporosis, EVISTA can be used to lower your chance of getting invasive breast cancer. EVISTA will not totally get rid of your chance of getting invasive breast cancer. Your doctor can estimate your risk of invasive breast cancer by assessing your personal risk factors. 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.

5. What are the side effects of 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.

The most common side effects are hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating. Hot flashes are more common during the first 6 months after starting treatment. In clinical trials, side effects were usually mild enough that most women did not stop taking EVISTA.

6. How do I take EVISTA?
Take one EVISTA tablet each day. You can take EVISTA any time of day, with or without food (it may be taken along with a calcium supplement, and/or vitamin D), as your healthcare professional prescribes.

7. Can EVISTA be taken with estrogen?
In clinical trials, EVISTA has not been studied in combination with any form of estrogen that comes in a pill, patch, or injection. EVISTA should not be taken with any of these forms of estrogen.

8. Can EVISTA be taken with aspirin or ibuprofen?
There are no data regarding taking EVISTA in combination with aspirin or ibuprofen. You should discuss all medications you are taking, including over-the-counter and herbal medications, with your healthcare professional.

9. How many women have been in clinical trials with EVISTA?
EVISTA has been studied extensively with more than 37,000 women involved in various clinical studies.

10. How many prescriptions have been filled for EVISTA?
Over 64 million prescriptions for EVISTA have been filled since the FDA initially approved it in 1997.

If you have additional questions about EVISTA, or would like more information,
please feel free to call:

1-800-LillyRx (1-800-545-5979)