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

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Strengthening Bones

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If you are a woman with postmenopausal osteoporosis at high risk for fracture, a prescription medication may already be a key part of your postmenopausal osteoporosis treatment plan, but it shouldn’t be the only part. Like all women, you still need to maintain a healthy lifestyle to help strengthen your bones.

Prolia® helps lower the risk for spine and hip fractures.

Prolia® has been proven to reduce fractures of the spine, hip, and other bones.

Next Learn More

Some forms of exercise can help build bone density.

Weight-bearing exercise—like walking—may help build bone density.

Learn More

Here are a few of the most important things you can do for your bones, as recommended by the National Osteoporosis Foundation (NOF) or the Office of the Surgeon General:

  • Limit alcohol. Heavy drinking can reduce bone formation. It can also increase your risk of falling and fracturing a bone.
  • Stop smoking. The chemicals in cigarettes can harm your bone cells. Smoking can also make it harder for your bones to absorb calcium.

Stories From Women Like You—Elizabeth

Elizabeth asked her doctor how she could strengthen her bones

  Read Text Version

Elizabeth

It really had not crossed my mind that I could have postmenopausal osteoporosis.

I'm a very active person. I volunteer a lot. I'm on my feet; I may not be as young as I used to be, but I feel strong.

My doctor said I should get tested, because: I'm over 65; I'm past menopause; and my mom broke her hip when she was 68. My doctor said that those are all factors that would raise my risk of having osteoporosis.

So I got tested—I had my bone density scan. Well, my results were really not good. My T-score was very low. My bones are weak. And it turns out my Vitamin D level is low too. My doctor said, you do have postmenopausal osteoporosis, and you need to know you're at high risk for fracture.

When I heard that, my first thought was, am I going to have to stop doing the things I'm doing? Ushering at the theater—I love that! And I'm on my feet, I'm walking stairs. Am I going to break something?

My doctor said, to reduce my risk of breaking a bone, we needed to talk about a management plan for helping to strengthen my bones. Okay then. Tell me how! We talked about finding the right treatment for me, finding a treatment that would help protect my bones from fracture, help to strengthen them, and fit with my lifestyle.

She said it wasn't enough to stop my bones from getting weaker. We're going to work on helping to make them stronger. I liked that. "Stronger bones."

My doctor prescribed Prolia®, also known as denosumab. She said it's for women like me with postmenopausal osteoporosis at high risk for fracture and explained how it works—that it helps stop the development of bone removing cells before they can weaken your bones.

We talked about the things I might experience while taking Prolia®—both the benefits and the side effects.

And another thing is—it's a shot under the skin, given once every 6 months in my doctor's office. That kind of schedule is a big plus for me.

So now I'm trying to do the things I need to do. I'm eating the right foods. I make sure I get my calcium, my Vitamin D that my doctor recommended, and I walk every day.

I'm proud of myself for that.

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®.

ELIZABETH: The thought that I could help strengthen my bones is so encouraging. I would recommend to anyone concerned about their postmenopausal osteoporosis, talk to your doctor. Find out what you should be doing as a part of your management plan.

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: