Pronunciation:

ral-OX-i-feen

Brand Names:

• Evista

Dosage Forms:

• Tablet

Warnings:

Increased risk of deep vein thrombosis and pulmonary embolism have been reported. Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride. Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Selective Estrogen Receptor Modulator

Uses of This Medicine:

Raloxifene is used to help prevent and treat thinning of the bones (osteoporosis) only in postmenopausal women.

It works like an estrogen to stop the bone loss that can develop in women after menopause, but it does not increase the bone density as much as daily 0.625 mg doses of conjugated estrogens. Raloxifene will not treat hot flashes of menopause and may cause hot flashes to occur. Also, raloxifene does not stimulate the breast or uterus as estrogen does.

Raloxifene lowers the blood concentrations of total and low-density lipoprotein (LDL) cholesterol, the bad cholesterols, but it does not increase concentrations of high-density lipoprotein (HDL) cholesterol, the good cholesterol, in your blood.

Raloxifene is also used to lower chances of having invasive breast cancer in postmenopausal women with osteoporosis or at high risk of having invasive breast cancer .

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Older adults—

This medicine has been tested only in women past menopause and has not been shown to cause different side effects or problems in elderly people than it does in adults who have just gone through menopause.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clot formation, active or history of, including deep vein thrombosis, pulmonary embolism, and retinal embolism—Raloxifene may slightly increase the chances of these conditions and, if they are already present, cause them to worsen. This medicine should not be used in patients with these conditions .

• Cancer or tumors or
• Congestive heart failure or
• Heart rhythm problems (e.g., atrial fibrillation) or
• High blood pressure or
• Stroke, history of or
• Transient ischemic attack (TIA), history of or
• Any other condition that increases the risk of blood clots—Taking raloxifene while having one of these conditions may worsen the chance that blood clots can form .

• Kidney disease or
• Liver disease—These conditions may cause higher concentrations of raloxifene in the blood .

Proper Use of This Medicine:

A paper with information for the patient will be given to you with your filled prescription, and will provide many details concerning the use of raloxifene. Read this paper carefully and ask your health care professional if you need additional information or explanation.

Many patients trying to prevent or treat bone loss will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For preventing bone loss:
    • Adults—60 mg once a day, with or without meals.
  • For treating bone loss:
    • Adults—60 mg once a day, with or without meals.
  • For preventing invasive breast cancer:
    • Adults—60 mg once a day, with or without meals .

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that you keep your appointments with your doctor even if you feel well.

Before you have any kind of surgery, tell the medical doctor in charge that you are using this medicine. Discuss discontinuing use of raloxifene 3 days before you think you will have a long period of inactivity, sitting, or bed rest, such as after having surgery or going on a long trip. The doctor may have you start the medicine again after you are back on your feet and fully mobile. If you are going on a trip and stay on raloxifene, you should walk regularly or move about when possible. Remaining still for long periods may cause blood clots for some people, and raloxifene may rarely worsen their condition.

If you are able to become pregnant, stop using the medicine immediately if you think you have become pregnant and check with your doctor. Raloxifene is recommended for women who are past menopause.

Raloxifene does not act like an estrogen to stimulate the uterus or breast. If you experience vaginal bleeding, breast pain or enlargement, or swelling of hands or feet while on raloxifene, you should report it to your doctor.

Other ways that may be used with raloxifene to help prevent or treat bone loss are taking calcium plus vitamin D supplements and getting weight-bearing exercise. You may want to discuss these options with your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

Coughing blood

headache or migraine headache

loss of or change in speech, coordination, or vision

pain or numbness in chest, arm, or leg

shortness of breath (unexplained)

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Bloody or cloudy urine

chest pain

difficult, burning, or painful urination

fever

frequent urge to urinate

infection, including body aches or pain, congestion in throat, cough, dryness or soreness of throat, runny nose, and loss of voice

leg cramping

skin rash

swelling of hands, ankles, or feet

vaginal itching

Less common

Abdominal pain (severe)

aching body pains

congestion in lungs

decreased vision or other changes in vision

diarrhea

difficulty in breathing

hoarseness

loss of appetite

nausea

trouble in swallowing

weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Hot flashes, including sudden sweating and feelings of warmth (especially common during the first 6 months of treatment)

increased white vaginal discharge

joint or muscle pain

mental depression

problems of stomach or intestines, including passing of gas, upset stomach, or vomiting

swollen joints

trouble in sleeping

weight gain (unexplained)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.