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

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Know Your Fracture Risk

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For many, the first sign of postmenopausal osteoporosis is a fracture. A major step toward helping to strengthen your bones is determining your fracture risk and if you are at high risk for fracture.

Are you at high risk for fracture?

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

  • Being female
  • Being over the age of 50
  • Menopause
  • Family history of osteoporosis
  • Very low body weight
  • Small, thin body frame
  • Previous broken bone as an adult
  • Height loss
  • Cigarette smoking
  • Drinking too much alcohol or caffeine
  • Eating too much protein or sodium (salt)
  • Inactive lifestyle
  • Losing weight
  • Not getting enough calcium and vitamin D
  • Not eating enough fruits and vegetables
  • Certain medications and diseases (talk to your doctor about your medical history)

* According to the National Osteoporosis Foundation

1 in 2 women over age 50 will have a fracture due to osteoporosis in her lifetime.

1 in 2 women over age 50 will have a future fracture due to osteoporosis.

Learn More

Measuring bone density

Bone density and fracture risk are closely related. The most common way to measure bone density is with a DXA (dual-energy x-ray absorptiometry) scan. If you are a postmenopausal woman taking an osteoporosis medication, the National Osteoporosis Foundation recommends bone density to be repeated every 2 years (or more frequently, as recommended by your doctor).

Routine testing of your bone density is very important—even if you know you have postmenopausal osteoporosis and are taking steps to manage it with prescription medication, along with calcium and vitamin D, diet, and exercise. Such tests help your doctor understand how your bone density is changing over time. Your doctor can use your results to assess your postmenopausal osteoporosis management plan.

Stories From Women Like You—Karen

It took a fractured wrist for Karen to realize she may need medication

Learn about a medication for postmenopausal osteoporosis

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

  Read Text Version

Last year I fractured my wrist.

It was my left wrist. I should be glad it wasn't my right.

The moment I fell—I've played that moment over so many times in my head… if I had stepped here instead of there… I wouldn't have stumbled… I felt so clumsy.

My doctor said, Karen, you didn't get a fracture from being clumsy, you got a fracture from having weak bones.

Oh.

What do you mean I have weak bones?

He explained that my bone density T‑score was minus 2.9, and that meant I had postmenopausal osteoporosis.

Told me all about it—how common it is among women after menopause, how your bones lose their density and can become brittle or weak, the risk of fractures, all of that. And what I could do to help strengthen my bones.

Well, I'm an active person. I teach. And I want to keep teaching. I have some good years left in me! So I'm doing everything my doctor told me to do to help strengthen my bones.

My doctor prescribed Prolia®, also known as denosumab. He said it's approved for women with postmenopausal osteoporosis who have a high risk for fracture.

That's me.

We looked at the Medication Guide together, and he explained the side effects I might experience.

He also explained how Prolia® works—that it helps stop the development of bone-removing cells before they cause bone loss.

It's not a pill, it's a shot every six months. That part—one shot every six months—I like that and it works for me.

And I'm doing everything else my doctor said. Vitamin D every day. Calcium supplements. Exercising.

I have had my first Prolia® shot, and I have my second one scheduled. And I know I'm doing what I can to help protect my bones against fracture.

I tell my students that every setback is an opportunity—but it's up to you to take advantage of it.

Well, for me, fracturing my wrist was a wake-up call. It was an opportunity to pay attention and start doing all I can to help strengthen my bones.

The end-result is, I'm trying to take much better care of my bones than I was a year ago.

Here's some Important Safety Information you should know about Prolia®.

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.

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.

Please see Prescribing Information and Medication Guide for complete details about Prolia®.

KAREN:
One thing I did get out of all of this is, it's good to talk to your doctor! Ask your doctor what you should be doing about your bones. Ask your doctor if Prolia® might be right for you.

Make a Plan to Help Manage Postmenopausal Osteoporosis

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. Ask your doctor about:

  • Bone density testing
  • Other risk factors for fracture
  • Your fracture risk and if you are at high risk for fracture

Need help talking to your doctor?

Prepare for your next appointment with this helpful questionnaire

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
See More

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: