Generic Name: raloxifene (oral) (ra LOX i feen)
Brand Name: Evista

What is raloxifene?

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

Raloxifene is used to treat or prevent osteoporosis in postmenopausal women. Raloxifene 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.

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

Raloxifene may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about raloxifene?

Taking raloxifene 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.

Raloxifene 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 menopause, diabetes, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or if you have had a hysterectomy).

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Do not take raloxifene if you are pregnant or may become pregnant.

Do not breast-feed while taking raloxifene.

What should I discuss with my healthcare provider before taking raloxifene?

Taking raloxifene 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.

You also should not use raloxifene if you are allergic to it, if you are pregnant or breast-feeding.

Raloxifene 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 menopause, diabetes, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or if you have had a hysterectomy).

To make sure raloxifene is safe for you, tell your doctor if you have:

  • coronary artery disease (atherosclerosis);

  • heart disease, high blood pressure;

  • a history of stroke (including "mini-stroke");

  • liver or kidney disease;

  • high triglycerides (usually occurs with high cholesterol);

  • if you have not gone through menopause;

  • if you have had breast cancer in the past; or

  • if you take a blood thinner (warfarin, Coumadin), cholesterol medication, or estrogen hormone replacement therapy.

FDA pregnancy category X. Although it is not likely that a postmenopausal woman would be pregnant, raloxifene can cause birth defects. Do not take this medicine if you are pregnant or may become pregnant. Tell your doctor right away if you become pregnant during treatment.

It is not known whether raloxifene passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Raloxifene is not for use in men.

How should I take raloxifene?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Raloxifene can be taken with or without food. You may take raloxifene at any time of the day, but try to take it at the same time each day.

If your raloxifene tablets are packaged on blister cards, take the medication as follows:

  • Each blister card contains 15 tablets labeled with a different day of the week. The first tablet you use should be labeled with the day of the week your doctor has instructed you to start taking raloxifene.

  • If you have refilled your prescription and are starting a new blister pack, take the tablet that is labeled one day after you took your last dose.

  • Keep taking the medication one tablet per day, unless your doctor has told you otherwise.

  • Try to take the medication at the same time each day.

  • The tablet in the center of the blister card should be the last tablet you take before starting a new card.

If you need to have any type of surgery or will be on bed rest, you will need to stop taking raloxifene for at least 72 hours before your surgery or before you plan to be immobile. Any doctor or surgeon who treats you should know that you are taking raloxifene.

Raloxifene is only part of a complete program of treatment that may also include diet, exercise, calcium or vitamin D supplements, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking raloxifene?

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 raloxifene.

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up 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.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Raloxifene side effects

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

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

  • lumps or other changes in the breast;

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

  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common 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.

See also: Side effects (in more detail)

What other drugs will affect raloxifene?

Other drugs may interact with raloxifene, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about raloxifene.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.01. Revision Date: 2013-11-06, 5:23:47 PM.

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