EVISTA

Postmenopausal osteoporosis may be diagnosed by history or radiographic documentation of osteoporotic fracture, bone mineral densitometry, or physical signs of vertebral crush fractures (e.g., height loss, dorsal kyphosis).

No single clinical finding or test result can quantify risk of postmenopausal osteoporosis with certainty. However, clinical assessment can help to identify women at increased risk. Widely accepted risk factors include Caucasian or Asian descent, slender body build, early estrogen deficiency, smoking, alcohol consumption, low calcium diet, sedentary lifestyle, and family history of osteoporosis. Evidence of increased bone turnover from serum and urine markers and low bone mass (e.g., at least 1 standard deviation below the mean for healthy, young adult women) as determined by densitometric techniques are also predictive. The greater the number of clinical risk factors, the greater the probability of developing postmenopausal osteoporosis.

WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE
Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA [see Warnings and Precautions (5.1)]. Women with active or past history of venous thromboembolism should not take EVISTA [see Contraindications (4.1)].

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 [see Warnings and Precautions (5.2) and Clinical Studies (14.5)].

These highlights do not include all the information needed to use EVISTA safely and effectively. See full prescribing information for EVISTA. EVISTA (raloxifene hydrochloride) Tablet for Oral use
Initial U.S. Approval: 1997

Possible side effects of raloxifene (Evista)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• chest pain, sudden cough, wheezing, rapid breathing, fast heart rate;
• pain or swelling in one or both legs;
• swelling in your hands or feet;
• fever, chills, sore throat, body aches, flu symptoms;
• unusual vaginal bleeding;
• breast pain, tenderness, or lump;
• pain or burning when you urinate; or
• severe pain in your lower back.

Less serious side effects may include:

• hot flashes;
• headache, dizziness, spinning sensation;
• leg pain;
• joint pain;
• increased sweating;
• nausea, vomiting, stomach pain; or
• runny or stuffy nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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After an assessment of the risk of developing breast cancer, the decision regarding therapy with EVISTA should be based upon an individual assessment of the benefits and risks.

EVISTA does not eliminate the risk of breast cancer. Patients should have breast exams and mammograms before starting EVISTA and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with EVISTA.

Important Limitations of Use for Breast Cancer Risk Reduction

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.