Raloxifene (patient information)

Why is this medication prescribed

Raloxifene is used to prevent and treat osteoporosis, a disease common in women past menopause, which results in bones that break easily. Raloxifene is in a class of medications called selective estrogen receptor modulators (SERMs). It works by acting similar to estrogen, a female hormone produced by the body. Like estrogen, raloxifene increases the density of bone.

How should this medicine be used

Raloxifene comes as a tablet to take by mouth. It is usually taken once a day at any time, with or without food. To help you remember to take raloxifene, take it 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.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. There is interest in possible beneficial effects of raloxifene on breast cancer risk in women.

What special precautions should I follow

Before taking raloxifene:

• tell your doctor and pharmacist if you are allergic to raloxifene or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin), cholestyramine (Questran) or colestipol (Colestid), diazepam (Valium, Valrelease, Zetran), diazoxide (Proglycem), and estrogen or hormone replacement therapy (ERT or HRT). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have cancer and if you have or have ever had breast lumps or cancer, high blood cholesterol or triglycerides, blood clots (e.g., in the legs, lung, or eye), phlebitis in the leg, heart failure, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking raloxifene, call your doctor immediately. Raloxifene may harm the fetus.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking raloxifene.
• you should know that raloxifene increases the risk of blood clots. Because being inactive also increases the risk of blood clots, you should stop taking raloxifene 72 hours before a long period of lying down (for example, when recovering from surgery or when on bedrest). Resume taking raloxifene once you become active again. During long trips, make sure to get up and walk around every once in a while.
• 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 uterine lining. However, tell your doctor if you develop unexplained vaginal bleeding or spotting.
• you should know that raloxifene has not been found to cause breast tenderness or swelling nor to increase the risk of breast cancer. However, tell your doctor if you notice any changes in your breasts.

What special dietary instructions should I follow

Follow all dietary and exercise recommendations, including those regarding calcium and vitamin D supplements.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Mild side effects

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

Severe side effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• sudden chest pain or chest heaviness
• difficulty breathing or coughing up blood
• pain, swelling, or warmth in the calves, legs, hands, or feet
• sudden change in your vision such as vision loss or blurring

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/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know

Keep all appointments with your doctor and the laboratory. You should have a complete physical examination, including blood pressure measurements, breast and pelvic exams, and a Pap test at least yearly. Follow your doctor's directions for examining your breasts; report any lumps immediately. Your doctor may order certain lab tests to check your body's response to raloxifene.

Before you have any laboratory tests, tell the person doing the test that you take raloxifene, as this medication may interfere with some lab tests.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Evista®

Other names

• Keoxifene