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.

Prolia® is a prescription medicine used to treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least six months and are at high risk for fracture.

Prolia® is a prescription medicine used to treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.

Prolia® is a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.

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Normal
bone

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

Interactive image of bone with a T-score of 0.0, which is what bone looks like without osteoporosis.

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

If you don’t know your T-score, ask your doctor to measure your bone density with a DXA scan

The importance of a DXA scan

Bone density is measured with a DXA scan (sometimes pronounced dexa). This is a fast and pain-free test that determines your T-score, and helps your doctor choose which treatment is right for you.

If you’re on an osteoporosis treatment, the National Osteoporosis Foundation recommends getting a DXA scan every 1 to 2 years. Your doctor may recommend you receive them more frequently depending on your condition and risk of fracture.

Women taking Prolia® for 3 years reduced their risk of new spine fractures by 68%. In a 3-year study, women not treated with Prolia® had more new spine fractures (7.2%) compared to women treated with Prolia® (2.3%). Study consisted of 7393 patients who received either Prolia® or a placebo (a treatment containing no medicine).

Along with treatment, these tips can also help
reduce your risk of falls and fractures

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Assess your
current condition

Talk to your doctor about other health conditions you may have that can cause you to fall.

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Fall-proof
your home

Keep home well lit and walking paths clear. Install handrails and keep kitchen items within reach.

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Reduce your risk
when out and about

Wear shoes with rubber soles, and look out for slippery surfaces, curbs, inclines, or steps.

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Enhance your daily diet

Make calcium-rich recipes to get enough calcium in your diet.

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Get your exercise

Weight-bearing and muscle-strengthening exercises may increase bone density and improve balance.

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Get enough calcium
& vitamin D

Even if you’re on a treatment, continue taking enough calcium and vitamin D daily.

In addition to considering these tips, talk with your doctor to see if Prolia® should be part of your treatment plan

Your bone-strengthening journey starts with these questions

Prolia® is proven to reduce the risk of fracture

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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).
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, skipping or delaying Prolia®. Talk with your doctor before starting Prolia® treatment. After your treatment with Prolia® is stopped, or if you skip or delay taking a dose, 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, skip or delay 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:
  • 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
  • Are taking medicine that can lower your blood calcium levels
  • Plan to have dental surgery or teeth removed
  • Are pregnant or plan to become pregnant
    Females who are able to become pregnant:
    • Your healthcare provider should do a pregnancy test before you start treatment with Prolia®.
    • You should use an effective method of birth control (contraception) during treatment with Prolia® and for at least 5 months after your last dose of Prolia®.
    • Tell your doctor right away if you become pregnant while taking Prolia®.
  • 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® 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).

The most common side effects of Prolia® in patients with corticosteroid-induced osteoporosis are back pain, high blood pressure, lung infection (bronchitis), and headache.

The most common side effects of Prolia® in patients receiving certain treatments for prostate or breast cancer are joint pain, back pain, pain in your arms and legs, and muscle pain. Additionally, in Prolia®-treated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed.

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.

Prolia® is a prescription medicine used to treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least six months and are at high risk for fracture.

Prolia® is a prescription medicine used to treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.

Prolia® is a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.

Please see Prolia® full Prescribing Information and Medication Guide.

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). 
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