EVISTA® (raloxifene HCl)

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.

Side Effects

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.

Stop taking your medication and call your healthcare professional right away if you have or have had any of the following signs of blood clots in the veins of the legs, lungs, or eyes:

leg pain or a feeling of warmth in the calves
swelling of the legs, hands, or feet
sudden chest pain, shortness of breath, or coughing up blood
sudden change in your vision, such as loss of vision or blurred vision

Questions or Concerns
These are not all the side effects of EVISTA. Tell your healthcare professional 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 healthcare professional or pharmacist for more information.

For more safety information about EVISTA, and important information for individuals taking EVISTA, see Important Safety Information. For general information about EVISTA, see Frequently Asked Questions.

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.

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

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

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EVISTA^® is a registered trademark of Eli Lilly and Company.
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