In the U.S.—

• Estrogen receptor modulator, selective
• osteoporosis prophylactic

Raloxifene ( ral-OX-i-feen) 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.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Tablets (U.S.)

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 raloxifene, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to raloxifene. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Raloxifene is not recommended during pregnancy. Presently, raloxifene is to be used in postmenopausal women only. It has been shown to cause serious birth defects or other problems in animals. Be sure you have discussed this with your doctor.

Breast-feeding—It is not known whether raloxifene passes into breast milk. However, raloxifene is not recommended during breast-feeding because it may cause unwanted effects in nursing babies. Presently, raloxifene is to be used in postmenopausal women only.

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.

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. When you are taking raloxifene, it is especially important that your health care professional know if you are taking any of the following:

• Cholestyramine (e.g., Questran)—Cholestyramine can significantly reduce the absorption of raloxifene

• Estrogens, injection (e.g., Premarin) or
• Estrogens, oral (e.g., Premarin, Estrace, Estratab) or
• Estrogens, transdermal (e.g., Climara, Estrace, Vivelle)—Raloxifene should not be used with estrogens

• Warfarin (e.g., Coumadin)—Raloxifene may decrease the effect of warfarin, and the dose of warfarin may need to be adjusted when adding or stopping raloxifene

• 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

• Cancer or tumors or
• Congestive heart failure 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

• Liver disease—This condition may cause higher concentrations of raloxifene in the blood

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

• 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.

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. If you have any questions about this, check with your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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.

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 side 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, and loss of voice;  runny nose ;  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 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• 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 above may also occur in some patients. If you notice any other effects, check with your doctor.