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Your bones are living, growing tissue. Your bones provide structural support, protect vital organs, and store the calcium essential for normal body functions. In order to understand how osteoporosis occurs, it is important to become familiar with the living, growing nature of bone tissue.
About Osteoporosis
Osteoporosis Risk
Bone Turn-Over Rate
Stages of Bone Loss
Spine Fracture Risk
About Osteoporosis
Osteoporosis is a bone condition that means "porous bone." The structure of healthy bone is similar to honeycomb. With osteoporosis, the holes and spaces in the honeycomb become larger, which means they have lost density or mass. Because of this, the bones become weak and may break more easily.
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Osteoporosis Risk
Here are some of the risk factors for osteoporosis:
- Female gender
- Advancing age – past menopause
- Family history
- A slender body build
- A personal history of smoking
- A personal history of drinking excess alcohol
This is not a complete list of the risk factors for osteoporosis in women past menopause. Only take prescription EVISTA if you are past menopause.
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Bone Turn Over
Bone undergoes a continuous cycle of resorption and formation. Old bone is routinely "resorbed," or carried away, by your body as part of its normal function.
At the same time, new bone is formed in your skeleton. The rate of old bone resorption and new bone formation changes over time.
After menopause, more bone is carried away than is formed. This results in overall bone loss, which can continue as you age.
When bone resorption happens too quickly, or new bone grows too slowly, a person may reach the point of developing osteoporosis.
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Stages of Bone Loss
- Decreased Estrogen Causes Bone Loss: Since the hormone estrogen helps protect against bone loss, less estrogen in your body results in more bone loss. That's why the years after menopause—when a woman's ovaries stop producing estrogen—is the time of life when bone loss is most rapid. In fact, women can lose up to 20% of their bone mass in the 5 to 7 years following menopause.
- Low Bone Density Can Lead to Osteoporosis: In people with low bone density, the chance of getting osteoporosis is greater.
- Osteoporotic Bones Can Break More Easily: Women past menopause with osteoporosis are more likely to break a bone in the hip, spine, and wrist. Other bones can break, too.
EVISTA should not be taken with estrogens in the form of pills, patches or injections.
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Spine Fracture Risk Women past menopause with osteoporosis may be more likely to experience a spine fracture.
And after a first spine fracture occurs, postmenopausal women are at a substantial risk for another spine fracture within the next 1-2 years.
If you are a woman past menopause with osteoporosis, it is important to talk to your doctor about ways you can help reduce your risk of spine fracture.
Your doctor may recommend ways to help make your bones stronger, including taking EVISTA once daily. EVISTA can be taken with calcium and vitamin D.
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Indication for EVISTA® (raloxifene HCI tablets)
EVISTA treats osteoporosis in women past menopause and lowers the chance of getting invasive breast cancer. EVISTA will not totally get rid of your chance of getting breast cancer.
If you already have or have had breast cancer, EVISTA does not treat it or prevent its return, and it does not reduce the risk of all forms of breast cancer.
EVISTA can be taken with calcium and vitamin D.
Indication for EVISTA® (raloxifene HCI tablets)
EVISTA treats and prevents osteoporosis in women past menopause.
Indication for EVISTA® (raloxifene HCI tablets)
EVISTA can be used to lower your chance of getting invasive breast cancer in women past menopause at high risk for invasive breast cancer. EVISTA will not totally get rid of your chance of getting breast cancer. Your doctor can estimate your risk of breast cancer by asking you about risk factors, such as:
- your age (getting older).
- family history of breast cancer in your mother, sister, or daughter.
- a history of any breast biopsy, especially an abnormal biopsy.
You and your doctor should talk about whether the possible benefit of EVISTA in lowering your chance of getting invasive breast cancer is greater than its possible risks.
If you already have or have had breast cancer, EVISTA does not treat it or prevent its return, and it does not reduce the risk of all forms of breast cancer.
Indications for EVISTA® (raloxifene HCI tablets)
EVISTA is a type of prescription medicine called a Selective Estrogen Receptor Modulator (SERM). EVISTA is for women after menopause,
and has more than one use: Osteoporosis: EVISTA treats and prevents osteoporosis by helping make your bones strong and less likely to break.
EVISTA can be taken with calcium and vitamin D. Invasive Breast Cancer: If you have osteoporosis or are at high risk for breast cancer,
EVISTA can be used to lower your chance of getting invasive breast cancer. EVISTA will not totally get rid of your chance of getting
breast cancer. Your doctor can estimate your risk of breast cancer by asking you about risk factors, such as: your age (getting older);
family history of breast cancer in your mother, sister, or daughter; a history of any breast biopsy, especially an abnormal biopsy.
You and your doctor should talk about whether the possible benefit of EVISTA in lowering your chance of getting invasive breast cancer
is greater than its possible risks.
If you already have or have had breast cancer, EVISTA does not treat it or prevent its return, and it does not reduce the risk of all forms of breast cancer.
Important Safety Information About EVISTA® (raloxifene HCl tablets)
You should not take EVISTA if you have had or are at risk for getting blood clots
in the legs, lungs or eyes, as it may increase the risk of blood clots. Stop taking
EVISTA and call your doctor if you have leg pain or warmth, swelling of the legs,
hands or feet, chest pain, shortness of breath or a sudden vision change, as these
may be signs of a blood clot. Being unable to move around for long periods may increase
this risk. If you will need to be still for a long time, talk to your doctor about
ways to reduce the risk of blood clots.
EVISTA does not increase the risk of a heart attack or stroke in women who have
had or are at risk for a heart attack; however; EVISTA increases the likelihood
of dying from stroke in these women, should one occur. Before taking EVISTA tell
your doctor if you have had a stroke, a mini-stroke, irregular heartbeat, high blood
pressure, heart attack, history of smoking, or believe you have other risk factors
for stroke or a heart attack.
EVISTA is not right for everyone. Do not take EVISTA if you:
- have had blood clots in your legs, lungs or eyes.
- are pregnant, nursing or may become pregnant, as EVISTA may cause fetal harm.
What should I tell my doctor before taking EVISTA?
Talk to your doctor about all your medical conditions including:
- If you have had blood clots in your legs, lungs or eyes.
- If you have had a stroke, mini-stroke, irregular heartbeat, high blood pressure, heart attack, history of smoking, or think you have other risk factors for stroke or heart attack.
- EVISTA should not be used for prevention of heart disease.
- If you are premenopausal. Only take prescription EVISTA if you are past menopause.
- If you have liver or kidney disease. Women with liver or kidney disease should use EVISTA with caution.
- EVISTA should not be taken with estrogens in the form of pills, patches or injections.
- If you have taken estrogen in the past and had a high increase of triglycerides (a kind of fat in the blood).
What are the possible side effects of EVISTA?
- Side effects may include hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088.
What are the possible drug interactions with EVISTA?
- If you take warfarin (Coumadin®, Jantoven®) or other coumarin blood thinners, you may need to do a blood test (prothrombin time, pro-time or INR) when you first start or if you need to stop taking EVISTA. Your doctor may need to adjust the dose of your warfarin or other coumarin blood thinners.
- EVISTA should not be taken with cholestyramine or estrogens.
See Full Prescribing Information and Medication Guide, including Boxed Warning for increased risk of blood clots and death from stroke.
RA ISI CON 28Sept2011
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