Indication  
Prolia® is a prescription medicine used to treat osteoporosis in women after menopause who:

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A Deeper Look at Postmenopausal Osteoporosis

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Osteoporosis is a disease that weakens bones over time. Because of this, it puts you at risk for breaking a bone. Postmenopausal osteoporosis is the most common form of osteoporosis. It affects many women after menopause, leaving some women at high risk for fracture.

Postmenopausal osteoporosis is a progressive disease—you need to monitor it over time.

T-scores from regular DXA scans can help your doctor monitor your bone density over time.

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Women taking a postmenopausal osteoporosis medication should get a bone density scan every 2 years.

According to the National Osteoporosis Foundation, they should get a scan every 2 years. (In some cases, a doctor may recommend more frequent testing.)

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How does postmenopausal osteoporosis develop?

  • Everyone has cells that remove old bone and other cells that rebuild new bone. This ongoing process is part of what keeps your bones strong. When you have postmenopausal osteoporosis, bone-removing cells cause you to lose bone at a rate that is too fast.
  • The result is thinner, weaker bones that can break more easily.
  • In women, bone loss increases after menopause. In the 5 to 7 years after menopause, you can lose up to 20 percent of your bone mass—leaving you at risk for fracture.

What is postmenopausal osteoporosis?

Hear Dr. Schneider explain postmenopausal osteoporosis

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Postmenopausal osteoporosis can occur in women after menopause when estrogen levels drop. It is a disease that makes your bones thinner and weaker—so that they are more likely to fracture or break. In fact, 1 in 2 women over age 50 will have a fracture due to osteoporosis in their lifetime.

Postmenopausal osteoporosis is often called a "silent disease." This is because it can develop without you knowing it. You don't feel your bones getting weaker, nor can you see them getting weaker. Many women have no idea they have postmenopausal osteoporosis until the day a bone breaks.

Talk to your doctor about ways you can find out whether you have postmenopausal osteoporosis. The most commonly used test is called a DXA scan. It's a test your doctor can arrange for you.

A silent but serious disease

Every woman past menopause should make strengthening her bones a priority. Here's why:

Postmenopausal osteoporosis is a silent disease…

  • You can't feel it.
  • You can't see it.
  • It usually has no symptoms until a fracture happens.
  • After age 50, 1 in 2 women will have a future fracture related to osteoporosis.
  • Once you have a fracture, your chance of another is much higher.

Learn about a medication for postmenopausal osteoporosis

2 shots a year can help strengthen bones and reduce your risk for fracture

Once you develop postmenopausal osteoporosis, it can be treated—but there is no "cure." If your doctor tells you that you are at high risk for fracture, then you can come up with a treatment plan together, which may include diet, calcium and vitamin D supplements, exercise, and medication.

Important Safety Information Close

Do not take Prolia® (denosumab) if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia® may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia®.

What is the most important information I should know about Prolia®?

If you receive Prolia®, you should not receive XGEVA®. Prolia® contains the same medicine as XGEVA® (denosumab).

Prolia® can cause serious side effects:

Serious allergic reactions have happened in people who take Prolia®. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives.

Low blood calcium (hypocalcemia). Prolia® may lower the calcium levels in your blood. If you have low blood calcium, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia®.

Take calcium and vitamin D as your doctor tells you to help prevent low blood calcium.

Severe jaw bone problems (osteonecrosis) may occur. Your doctor should examine your mouth before you start Prolia® and may tell you to see your dentist. It is important for you to practice good mouth care during treatment with Prolia®.

Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take Prolia®. You may need to go to the hospital for treatment.

Prolia® is a medicine that may affect the ability of your body to fight infections. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections.

Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.

Bone, joint, or muscle pain. Some people who take Prolia® develop severe bone, joint, or muscle pain.

Before taking Prolia®, tell your doctor if you:

  • Take the medicine XGEVA® (denosumab)
  • Have low blood calcium
  • Cannot take daily calcium and vitamin D
  • Had parathyroid or thyroid surgery (glands located in your neck)
  • Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
  • Have kidney problems or are on kidney dialysis
  • Plan to have dental surgery or teeth removed
  • Are pregnant or plan to become pregnant
  • Are breast-feeding or plan to breast-feed

What are the possible side effects of Prolia®?

It is not known if the use of Prolia® over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia® are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.

These are not all the possible side effects of Prolia®. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indication Prolia® is a prescription medicine used to treat osteoporosis in women after menopause who:

  • are at high risk for fracture, meaning women who have had a fracture related to osteoporosis, or who have multiple risk factors for fracture
  • cannot use another osteoporosis medicine or other osteoporosis medicines did not work well
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Important Safety Information

 Do not take Prolia® (denosumab) if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia® may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia®.

What is the most important information I should know about Prolia®?

If you receive Prolia®, you should not receive XGEVA®. Prolia® contains the same medicine as XGEVA® (denosumab).

Prolia® can cause serious side effects: