Indications

Prolia® is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well. Read More

Prolia® is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture. Read Less

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Prescribing Information | Medication Guide
Important Safety Information | Indications

Important Safety Information

Do not take Prolia® 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).

Postmenopausal Osteoporosis

Postmenopausal osteoporosis is a bone disease that weakens bones over time, making them thinner, more brittle, and more likely to break.

The Importance Of STRONG BONES


Postmenopausal osteoporosis is a silent, chronic disease. It is not just a normal part of aging. It needs to be taken seriously.

The importance of treating now
Woman Osteoporosis

Left untreated, your bones will only become weaker and more brittle. This could lead to a change in your posture.

Weak bones also fracture more easily. A fracture can make it difficult to get around and do things on your own. What would a fracture mean for you?

DID YOU KNOW?

You can lose up to 20%
of your bone mass in the 5 to 7 years after menopause. This puts you at increased risk for fracture.

Pie Chart 20%
Figures icon

Half of all women over 50
will have a fracture due to osteoporosis in their lifetime.

You don't have to accept weak bones as your new reality. Talk to your doctor about finding a treatment plan that works for you.

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Learn About
A TREATMENT OPTION FOR POSTMENOPAUSAL OSTEOPOROSIS

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Risk Factors For Bone Fractures

Whether you've suffered a fracture or not, if you are a postmenopausal woman, there are many factors that may place you at high risk for fracture:*

  • Over the age of 65
  • Low bone mineral density
  • Increased risk of falling
  • History of hip fracture in a parent
  • Small, thin body frame
  • Previous broken bone as an adult
  • Cigarette smoking
  • Inactive lifestyle
  • Not getting enough calcium or vitamin D

* According to the National Osteoporosis Foundation.

How To Measure YOUR BONE DENSITY

The most common bone density test is called DXA (sometimes pronounced "D-EXA"). A DXA scan is usually done at the hip and spine to measure bone mineral density. But osteoporosis is not limited to just one part of the body. It affects all the bones.

The results of this scan are reported as a T-Score, which compares your bone density to that of a healthy 30-year-old woman.

DXA scan

Patient undergoing a DXA scan

T-Score

Bone images courtesy of David W. Dempster, Ph.D., 2000.
Reproduced with permission.

T-Score

The most common way to measure bone density is with a DXA (dual-energy x-ray absorptiometry) scan.

A DXA scan test (sometimes said as "dexa" scan) is fast, accurate, pain-free, and uses very little radiation. A DXA scan provides the doctor with a T-Score that helps determine your risk for fracture.

A T-Score of -2.5 or lower is defined as osteoporosis. The lower the score, the weaker your bones are, and the greater your risk of fracture.

Who Should Get A DXA Scan?

The National Osteoporosis Foundation recommends women to get a DXA scan IF:

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You are 65 or older

50+ icon

You are a woman going through menopause early or are 50+, and have risk factors such as prior fracture as an adult, prone to falling, family history of bone fractures, low calcium intake, low body weight, or low physical activity.

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You are a woman of any age, and you are taking a medication or have a condition that makes your bones weak



If you are currently taking osteoporosis medications, you should have a DXA scan every 2 years to measure your bone strength

Take charge of your bone health and know your T-Score!

Important Safety Information Close

Do not take Prolia® 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.

Increased risk of broken bones, including broken bones in the spine, after stopping Prolia®. After your treatment with Prolia® is stopped, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop taking Prolia® without first talking with your doctor. If your Prolia® treatment is stopped, talk to your doctor about other medicine that you can take.

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 about all of your medical conditions, including if you:

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® in women being treated for osteoporosis after menopause are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection. The most common side effects of Prolia® in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat).

These are not all the possible side effects of Prolia®. 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.

Indications

Prolia® is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.

Prolia® is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture.

Please see Prolia® full Prescribing Information and Medication Guide.