Evista

The active ingredient in Evista is raloxifene hydrochloride. Evista is an estrogen agonist and antagonist (selective estrogen receptor modulator [SERM]), which is known to stop the effects of the hormone estrogen on cells. Evista operates by strengthening bones as it binds to estrogen receptors and mimics estrogen, which decreases bone loss and increases bone mineral density. Additionally, it can lower your risk of developing breast cancer by blocking the estrogen hormone’s effects on breast tissue.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Evista. However, the following is a synopsis of the general guidelines for the use of Evista:

• Take this medication orally as directed by your physician. It is typically taken once a day.
• Adequate calcium and vitamin D supplements should be taken while taking this medication.
• If you need major surgery or will be on long-term bed rest, you will need to stop taking Evista at least 3 days ahead of time.

The most common side effects of Evista seen in clinical trials as compared to placebo include:

• Hot flashes/flushes.
• Joint pain.
• Leg cramps.
• Sweating.
• Swelling of the ankles, hands, or feet.
• Cough.
• Headache.
• Nausea.

Some individuals may experience serious side effects while using Evista. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Allergic reactions - skin rash, itching, hives, swelling.
• Increased risk of blood clots - pain, swelling, or warmth in the leg, shortness of breath, chest pain.
• Stroke - sudden numbness, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision.
• Vaginal bleeding after menopause.
• Breast pain.

These are not all of the possible side effects of Evista. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Evista, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have a personal or family history of:

• Blood clots.
• Cancer.
• Heart disease (atrial fibrillation).
• Heart attack.
• High levels of triglycerides (blood fat) in the blood.
• Stroke.
• Kidney disease.
• Transient ischemic attack (TIA).
• Liver disease.
• Premenopausal.
• Smoke tobacco.
• Allergic reaction to raloxifene.
• Pregnant.
• Breastfeeding.

Boxed Warning

• Increased incidence of deep vein thrombosis and pulmonary embolism have been reported with taking Evista.
• Increased risk of death due to stroke occurred in postmenopausal women with documented coronary heart disease.

• Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
• A pregnant woman.

Research has shown that Evista significantly and consistently suppressed bone turnover within three months.

When Evista is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Medications to lower cholesterol (cholestyramine).
• Blood thinning medications (warfarin).
• Highly protein-bound drugs.

Evista comes as a 60 mg oral tablet.

Store at room temperature and keep out of reach of children.

Eli Lilly and Company is the pharmaceutical company that manufactures the brand name Evista.

There are lower-cost generics available for the brand name Evista.

Do not stop or adjust your use of this medication without first consulting with your doctor.

Evista should not be taken while pregnant. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Evista should not be taken while breastfeeding. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.