Evista

What is the most important information I should know about Evista (Raloxifene)?

You should not use this medication if you are allergic Blue Diamond to raloxifene, if you are pregnant or breast-feeding, or if you have ever had a blood clot.

Although it is not likely that a postmenopausal woman would be pregnant, raloxifene can cause birth defects and should not be used during pregnancy. Tell your doctor right away if you become pregnant during treatment.

Before taking raloxifene, tell your doctor if you smoke or if you have coronary artery disease, heart disease, high blood pressure, liver or kidney disease, a history of stroke or TIA, high triglycerides, if you have not gone through menopause, or if you have had breast cancer in the past.

If you need to have any type of surgery or will be on bed rest, you will need to stop taking raloxifene for at least 72 hours before your surgery or before you plan to be immobile. Any doctor or surgeon who treats you should know that you are taking raloxifene.

Avoid sitting still for long periods of time during travel while you are taking raloxifene.

What should I discuss with my healthcare provider before taking Evista (Raloxifene)?

You should not use this medication if you are allergic to raloxifene, if you are pregnant or breast-feeding, or if you have ever had a blood clot.

Before taking this medication, tell your doctor if you smoke or if you have:

• coronary artery disease (atherosclerosis)
• heart disease
• high blood pressure
• liver or kidney disease
• a history of stroke or TIA ("mini-stroke")
• high triglycerides (often occurs with high cholesterol)
• if you have not gone through menopause; or
• if you have had breast cancer in the past

If you have any of these conditions, you may need a dose adjustment or special tests to safely take raloxifene.

FDA pregnancy category X. Although it is not likely that a postmenopausal woman would be pregnant, raloxifene can cause birth defects and should not be used during pregnancy. Tell your doctor right away if you become pregnant during treatment.

It is not known whether raloxifene passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

What are the possible side effects of Evista (Raloxifene)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness, especially on one side of the body
• sudden headache, confusion, problems with vision, speech, or balance
• chest pain, sudden cough, wheezing, rapid breathing, fast heart rate
• pain or swelling in one or both legs
• swelling in your hands or feet
• fever, chills, sore throat, body aches, flu symptoms
• unusual vaginal bleeding
• breast pain, tenderness, or lump
• pain or burning when you urinate; or
• severe pain in your lower back

Less serious side effects may include:

• hot flashes
• headache, dizziness, spinning sensation
• leg pain
• joint pain
• increased sweating
• nausea, vomiting, stomach pain; or
• runny or stuffy nose

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Evista Drug Description

EVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:

The chemical designation is methanone Siagra, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl) has the empirical formula C₂₈H₂₇NO₄S•HCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl is an off-white to pale-yellow solid that is very slightly soluble in water.

EVISTA (raloxifene) is supplied in a tablet dosage form for oral administration. Each EVISTA tablet contains 60 mg of raloxifene HCl, which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include anhydrous lactose, carnauba wax, crospovidone, FD&C Blue No. 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, modified pharmaceutical glaze, polyethylene glycol, polysorbate 80, povidone, propylene glycol, and titanium dioxide.

SIDE EFFECTS:Hot flashes, sweating, or leg cramps may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Raloxifene may infrequently cause stroke or serious blood clots to form in the legs, lungs, or eyes. Seek immediate medical attention if any of these unlikely but serious side effects occur: leg swelling/pain, trouble breathing, chest pain, sudden vision changes, severe headache, weakness on one side of the body, confusion.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS:See also Warning section.

Before taking raloxifene, tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active or past history of blood clots (e.g., deep venous thrombosis, pulmonary embolism, retinal vein thrombosis).

Lack of movement may increase the risk for blood clots. Your doctor will instruct you to stop taking this medication at least 3 days before surgery or during long periods of inactivity (e.g., bedrest). Do not start taking raloxifene until you are routinely and actively moving again. During long periods of travel, walk or move periodically to keep the blood flowing through your body.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, high blood pressure, smoking, heart/blood vessel disease (e.g., congestive heart failure, atrial fibrillation, stroke, transient ischemic attack), cancer, high blood cholesterol levels, history of high blood fat (triglyceride) levels due to estrogen treatment.

This medication must not be used during pregnancy because it may cause harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately.

It is not known whether this drug passes into breast milk. Breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.