Evista affects the cycle of bone formation and breakdown in the body, and reduces loss of bone tissue.

Evista is used to treat or prevent osteoporosis in postmenopausal women. Evista is also used to reduce the risk of invasive breast cancer in postmenopausal women who have osteoporosis or who are otherwise at risk of invasive breast cancer.

Evista is not a cancer medication and will not treat breast cancer.

Taking Evista may increase your risk of a blood clot in your leg, your lung, or your eye. You should not take this medicine if you have ever had a blood clot.

Evista can also increase your risk of a stroke, which can be fatal. This risk is highest if you have coronary heart disease or certain risk factors (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol, or having a family history of coronary artery disease).

Although this medicine is for use only in postmenopausal women, you should not take Evista if you are pregnant or breastfeeding.

Take Evista exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take the medicine at the same time each day, with or without food.

If you need major surgery or will be on long-term bed rest, you will need to stop taking Evista at least 3 days ahead of time. You may not be able to restart the medicine until you are active again. Tell any doctor or surgeon who treats you that you take this medicine.

Evista is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin D supplements. Follow your doctor's instructions very closely.

Your doctor should check your progress on a regular basis. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Osteoporosis:

60 mg orally per day

Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

Usual Adult Dose for Prevention of Osteoporosis:

60 mg orally per day

Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

Usual Adult Dose for Prevention of Breast Cancer:

60 mg orally per day

Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

This medicine may increase your risk of a blood clot in your leg, your lung, or your eye. You should not take Evista if you have ever had this type of blood clot.

This medicine is for use only in women who can no longer get pregnant. Raloxifene can harm an unborn baby. Do not use if you are pregnant or may become pregnant.

Do not breastfeed while taking Evista.

Raloxifene can increase your risk of a stroke, which can be fatal. Tell your doctor if you have ever had:

• heart problems, irregular heartbeats;

• a heart attack or stroke, including "mini-stroke";

• high blood pressure;

• cancer; or

• if you smoke.

To make sure Evista is safe for you, tell your doctor if you have ever had:

• a blood clot;

• high triglycerides caused by using estrogen;

• liver or kidney disease;

• endometriosis;

• abnormal vaginal bleeding; or

• if you have not gone through menopause.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

If you take calcium supplements, do not take more than your doctor has prescribed. Taking more calcium than recommended will not provide extra protection for your bones, and may cause serious side effects including kidney stones.

Avoid sitting still for long periods of time during travel while you are taking Evista.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Evista: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• swelling, tenderness, or other changes in your breasts;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), slurred speech, vision problems;

• signs of a blood clot in the lung - chest pain, trouble breathing, coughing up blood; or

• signs of a blood clot deep in the body - swelling, warmth, or redness in an arm or leg.

Common Evista side effects may include:

• hot flashes;

• leg cramps;

• swelling in your hands, feet, or ankles;

• joint pain;

• flu symptoms; or

• increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• cholestyramine;

• warfarin (Coumadin, Jantoven); or

• birth control pills or hormone replacement therapy.

This list is not complete. Other drugs may interact with raloxifene, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.