Trade Name:  Evista^®

Drug Type:

Raloxifene is a hormone therapy. Raloxifene is classified as a Selective Estrogen Receptor Modulator (SERM) (for more detail, see "How Raloxifene Works" section below).

What Raloxifene Is Used For:

• This medicine is given to prevent or treat osteoporosis (bone thinning) in women who have stopped having their periods (postmenopausal).
• Raloxifen has been approved for reduction in risk of breast cancer in postmenopausal women who have osteoporosis and for postmenopausal women at high risk for breast cancer.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Raloxifene Is Given:

• Raloxifene is given to you in a pill form. There is no intravenous (IV) preparation available. Take this medicine with a full glass of water, at the same time each day. If you miss a dose, do not take a double dose the next day. This medicine is to be taken once a day.
• In addition to Raloxifene, your healthcare provider may recommend that you take a calcium supplement with vitamin D (Vitamin D helps the calcium be absorbed better).
• The amount of Raloxifene that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and length of time you will take Raloxifene.

Side Effects:

Important things to remember about the side effects of Raloxifene:

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset and duration.
• Side effects are almost always reversible and will go away after treatment is complete.
• There are many options to help minimize or prevent side effects.
• There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

The following side effects are common (occurring in greater than 30%) for patients taking Raloxifene:

Note:  There are no common side effects of Raloxifene

These side effects are less common side effects (occurring in about 10-29%) of patients receiving Raloxifene:

• Hot flashes (see sexuality)
• Flu-like syndrome
• Joint pain
• Rhinitis (see cold symptoms)

A rare, but serious side effect of Raloxifene is blood clots, including deep vein thrombosis (DVT) and pulmonary embolus. You should seek emergency help and notify your health care provider immediately if you develop sudden chest pain and shortness of breath. Notify your health care provider within 24 hours if you notice that one leg is swollen, red, painful and/or warm to touch and the other is not.

Your fertility, meaning your ability to conceive or father a child, may be affected by Raloxifene. Please discuss this issue with your health care provider.

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Seek emergency help immediately and notify your health care provider, it you experience the following symptoms:

• Sudden shortness of breath and/or chest pain

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Swelling, redness and/or pain in one leg or arm and not the other
• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Pain that is unrelieved with prescribed medication

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting Raloxifene treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, or products containing aspirin unless your doctor specifically permits this.
• This medicine may increase your risk for developing blood clots. Tell your doctor or health care provider if you have ever had a blood clot in your legs, lungs or if you have ever had a stroke. If you are having surgery, or will be in bed for long periods of time, your doctor may temporarily tell you to stop taking the medication, until you recover.
• Tell your doctor if you have a history of liver or kidney disease.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category X (Raloxifene may cause fetal harm when given to a pregnant woman. Raloxifene must not be given to a pregnant woman or a woman who intends to become pregnant. If a woman becomes pregnant while taking Raloxifene, the medication must be stopped immediately and the woman given appropriate counseling).
• For both men and women: Do not conceive a child (get pregnant) while taking Raloxifene. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking Raloxifene.

Self-Care Tips:

• If you are experiencing hot flashes, wearing light clothing, staying in a cool environment, and putting cool cloths on your head may reduce symptoms. Consult your health care provider if these worsen, or become intolerable.
• For flu-like symptoms, keep warm with blankets and drink plenty of liquids. There are medications that can help reduce the discomfort caused by chills.
• Acetaminophen or ibuprofen may help relieve discomfort from fever, headache and/or generalized aches and pains. However, be sure to talk with your doctor before taking it.
• Raloxifene causes little nausea. But if you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also help.
• Make sure you exercise as often as possible. Light walking 4-5 times per week, for 20-30 minutes at a time will increase your energy level, decrease your chance of developing blood clots, and help strengthen your bones.
• Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

• Your health care provider will want to do blood tests to see how well you are responding to Raloxifene. Keep all appointments for tests, and office visits.
• Women will need a gynecologic (GYN) examination before therapy, and during therapy, at regular intervals. Discuss the appropriate schedule with your healthcare provider.
• Bone mineral density (BMD) should be done periodically to determine how strong your bones are. You may need this at least every 2 years, or sooner if your healthcare provider suggests.
• Your doctor may also monitor other types of blood work, to see if the medication is affecting other parts of your body.

How Raloxifene Works:

Hormones are chemical substances that are produced by glands in the body, which enter the bloodstream and cause effects in other tissues. For example, the hormone testosterone, made in the testicles and is responsible for male characteristics such as deepening voice and increased body hair. The use of hormone therapy to treat cancer is based on the observation that receptors for specific hormones that are needed for cell growth are on the surface of some tumor cells. Hormone therapy can work by stopping the production of a certain hormone, blocking hormone receptors, or substituting chemically similar agents for the active hormone, which cannot be used by the tumor cell. The different types of hormone therapies are categorized by their function and/or the type of hormone that is affected.

Selective Estrogen Receptor Modulator: [Raloxifene] SERM (Selective Estrogen Receptor Modulator) describes drugs that act like estrogen in some organs and as an anti-estrogen in others.

Raloxifene acts like estrogen to prevent bone loss and improve lipid profiles (decreases total and LDL cholesterol but does not raise triglycerides), but it has the potential to block some estrogen effects such as those that lead to breast cancer and uterine cancer.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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