Raloxifene

Conditions Treated

Raloxifene is used to prevent and treat osteoporosis (condition in which the bones become thin and weak and break easily) in women who have undergone menopause (change of life; end of menstrual periods). Raloxifene is also used to decrease the risk of developing invasive breast cancer (breast cancer that has spread outside of the milk ducts or lobules into the surrounding breast tissue) in women who are at high risk of developing this type of cancer or who have osteoporosis. Raloxifene cannot be used to treat invasive breast cancer or to prevent invasive breast cancer from coming back in women who have already had the condition. Raloxifene also cannot be used to decrease the risk of developing non-invasive breast cancer. Raloxifene is in a class of medications called selective estrogen receptor modulators (SERMs). Raloxifene prevents and treats osteoporosis by mimicking the effects of estrogen (a female hormone produced by the body) to increase the density (thickness) of bone. Raloxifene decreases the risk of developing invasive breast cancer by blocking the effects of estrogen on breast tissue. This may stop the development of tumors that need estrogen to grow.

Possible Side Effects

What Side Effects Can This Cause?

Raloxifene may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• hot flashes (more common in the first 6 months of raloxifene therapy)
• leg cramps
• swelling of the hands, feet, ankles, or lower legs
• flu-like syndrome
• joint pain
• sweating
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of the symptoms mentioned in the IMPORTANT WARNING section, call your doctor immediately.Raloxifene may cause other side effects. Call your doctor if you experience any unusual symptoms while you are taking this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Raloxifene comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take raloxifene at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take raloxifene exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Continue to take raloxifene even if you feel well. Do not stop taking raloxifene without talking to your doctor.

What Dietary Instructions Should I Follow

You should eat and drink plenty of foods and drinks that are rich in calcium and vitamin D while you are taking raloxifene. Your doctor will tell you which foods and drinks are good sources of these nutrients and how many servings you need each day. If you find it difficult to eat enough of these foods or if you have a condition that makes it difficult for your body to absorb the nutrients that you eat, tell your doctor. In that case, your doctor can prescribe or recommend a supplement.

Are There Any Special Instructions

Before taking raloxifene, tell your doctor and pharmacist if you are allergic to raloxifene or any other medications. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin), cholestyramine (Questran), colestipol (Colestid), diazepam (Valium), diazoxide (Proglycem), medications that contain estrogen such as hormone replacement therapy (ERT or HRT), and lidocaine (Lidoderm, Xylocaine). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you have any type of cancer and if you have or have ever had breast lumps or breast cancer; heart failure; kidney disease; or liver disease. If you have ever taken estrogen, tell your doctor if your triglycerides increased during your treatment. you should know that raloxifene has not been found to cause spotting or menstrual-like bleeding nor to increase the risk of cancer of the lining of the uterus. Tell your doctor if you develop vaginal bleeding or spotting. Your doctor will need to examine you or order tests to find the cause of the bleeding. you should know that although raloxifene decreases the chance that you will develop invasive breast cancer, there is still a risk that you will develop this condition. You will still need regularly scheduled breast exams and mammograms before you start taking raloxifene and during your treatment with raloxifene. Call your doctor if you notice tenderness, enlargement, lumps, or any other changes in your breasts. if you are taking raloxifene to treat osteoporosis, talk to your doctor about other things you can do to prevent osteoporosis from developing or worsening. Your doctor will probably tell you to avoid smoking and drinking large amounts of alcohol and to follow a regular program of weight-bearing exercise.