Generic Name: Raloxifene (reh-LOCKS-eh-feen)
Trade Name: Evista®
For which conditions is this drug approved? Raloxifene is FDA approved for the prevention and treatment of osteoporosis in postmenopausal women. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Raloxifene is classified as a selective estrogen receptor modulator (SERM). Raloxifene produces its effects by binding to estrogen receptors and stimulating some of the biological effects normally achieved by estrogen.
How is raloxifene typically given (administered)? Raloxifene is given orally, in the form of a tablet
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with raloxifene. Patients may undergo physical examinations, scans or other measures to assess side effects and response to therapy.
In addition, patients may have their hormone levels monitored. Patients may also be monitored for deep vein thrombosis, or blood clots. Patients experiencing sudden difficulty in breathing or chest pain, sudden headache with visual disturbances or changes in vision, or swelling, redness or pain of one extremity and not the other.
What are the common side effects that occur in patients treated with raloxifene?
• Hot flashes
• Leg cramps
• Joint pain
• Runny nose
• Flu-like symptoms
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Raloxifene should be taken with water.
• Patients should wear cool clothing and remain in a cool environment if possible if they are experiencing hot flashes.
Are there any special precautions patients should be aware of before starting treatment?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients taking warfarin may require extra monitoring when starting or stopping therapy with raloxifene.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• If an oral dose is missed, do not double up on doses. Patients should contact their doctor in this event.
• Keep tablets out of reach of children and return to the pharmacy for safe disposal if treatment is terminated.
When should patients notify their physician?
• Chest pain, jaw pain, difficulty breathing, noticeable changes in heart rate or rhythm
• Swelling, tenderness, redness in one extremity and not the other
• Severe or prolonged headache
• Sudden difficulty breathing
• Sudden headache with vision changes or difficulty in speech
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
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