Approved Uses

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.

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. Read Less

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For women with osteoporosis after menopause at high risk for fracture

Prolia® isn't just for women with postmenopausal osteoporosis— it's also an approved treatment for these conditions

Discover what else Prolia® treatment can help with.

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Benefits of Prolia® for men with osteoporosis

Benefits of Prolia® for corticosteroid-induced osteoporosis

Benefits of Prolia® for cancer treatment-induced bone loss

Benefits of Prolia® for men with osteoporosis

Benefits of Prolia® for men with osteoporosis

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

Prolia® is a bone-strengthening treatment that has your back

Men, don't wait for back pain, height loss, or even a fracture to get serious about male osteoporosis. Ask your doctor if Prolia® can help.

When it comes to osteoporosis, there are specific risk factors for men

According to the Bone Health & Osteoporosis Foundation, there are several factors that may lead to osteoporosis in men:

  • Low bone density
  • Parental history of fractures
  • Certain medication or certain medical conditions that can cause bone loss
  • Advanced age
  • Alcohol consumption
  • Prior fracture in men 50 years or older
  • Glucocorticoid use
  • Low testosterone or estrogen levels

Men are less likely to get evaluated and/or treated for osteoporosis than women

Assessment of risk for osteoporosis primarily occurs after a fracture. However, the best way of identifying men at high risk for osteoporosis is to measure bone mineral density (BMD)

See how Prolia® works in people with osteoporosis by moving the bar below from side to side

Without
treatment

An excess of bone-removing cells in your body makes you lose bone faster than your body can rebuild it, putting you at risk for fracture.

With
Prolia®

Prolia® is an injection that works with your body to help stop the development of bone-removing cells.

Interactive slider image showing bone-removing cells impacting your bone without treatment and with Prolia® (denosumab)
Interactive slider image showing bone-removing cells impacting your bone without treatment and with Prolia® (denosumab)

Doctors have been prescribing Prolia® to help men with osteoporosis at high risk for fracture since 2012

Increases bone densityHelps increase bone density
Prolia® (denosumab) is one shot, every 6 monthsHelps make bones stronger with 1 shot every 6 months

You should take calcium and vitamin D as your doctor tells you to while you receive Prolia®. 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. Do not stop, skip or delay taking Prolia® without first talking with your doctor.

Help maintain the effects of Prolia® by continuing to take Prolia® once every 6 months as directed by your doctor
Prolia® requires fewer doses than most other osteoporosis treatments indicated for men
Osteoporosis treatment
Frequency of dosing
Prolia

Prolia® injections administered by a healthcare professional

 

Once every 6 months

Oral bisphosphate tablets

Oral bisphosphonate tablets

 

Once daily

Once weekly

Once monthly

Self-administered injections

Self-administered injections

 

Once daily

Intravenous infusion

Intravenous infusion

 

Once yearly

Osteoporosis treatment

Frequency of dosing
Prolia® injections administered by a healthcare professional Once every
6 months
Other injections administered by a healthcare professional Once monthly
Oral bisphosphonate tablets

Once daily

Once weekly

Once monthly
Self-administered injections

Once daily
Intravenous infusion

Once yearly

Osteoporosis treatment

Frequency of dosing
Prolia® injections administered by a healthcare professional Once every
6 months
Oral bisphosphonate tablets

Once daily

Once weekly

Once monthly
Self-administered injections

Once daily
Intravenous infusion

Once yearly
A woman taking a photo

Learn how Prolia® works

Find out how the targeted treatment Prolia® stops the development of bone-removing cells.

DISCOVER HOW

Cost support for Prolia®

What you pay for Prolia® depends on your insurance plan.

SEE INSURANCE TYPES
A man looking at his smartphone

Benefits of Prolia® for corticosteroid-induced osteoporosis

Benefits of Prolia® for corticosteroid-induced osteoporosis

Prolia® is a treatment for adults taking corticosteroids for at least 6 months and who are at high risk for fracture

Your corticosteroid medicine could increase your risk of fracture

If you are being treated with a corticosteroid medicine, such as prednisone, and have been for at least 6 months, for conditions including rheumatoid arthritis (RA) or chronic obstructive pulmonary disease (COPD), your bones are more likely to become thin, brittle, and at risk of fracturing.

Talk to your doctor to see if Prolia® is right for you

See how Prolia® works in people with osteoporosis by moving the bar below from side to side

Without
treatment

An excess of bone-removing cells in your body makes you lose bone faster than your body can rebuild it, putting you at risk for fracture.

With
Prolia®

Prolia® is an injection that works with your body to help stop the development of bone-removing cells.

Interactive slider image showing bone-removing cells impacting your bone without treatment and with Prolia® (denosumab)
Interactive slider image showing bone-removing cells impacting your bone without treatment and with Prolia® (denosumab)

This 1-year study included people on a corticosteroid treatment, such as prednisone, at the same time, for certain inflammatory conditions such as rheumatoid arthritis (RA) or chronic obstructive pulmonary disease (COPD).

Increase bone strength in 12 months Increase bone strength in 12 months

People who took Prolia® saw a SIGNIFICANT INCREASE in the bone density of their spine and hip at 12 MONTHS, compared to those taking risedronate.*

*Risedronate is a common osteoporosis treatment.

These side effects occurred in at least 2% of people taking Prolia® and more frequently than with Risedronate

Most Common Side Effects Prolia® (n=394) Risedronate (n=384)
Back pain 18 people out of 394 17 people out of 384
High blood pressure 15 people out of 394 13 people out of 384
Bronchitis 15 people out of 394 11 people out of 384
Headache 14 people out of 394 7 people out of 384

Prolia® requires fewer doses than most other treatments

for corticosteroid-induced osteoporosis

Osteoporosis treatment
Frequency of dosing
Prolia

Prolia® injections administered by a healthcare professional

 

Once every 6 months

Oral bisphosphate tablets

Oral bisphosphonate tablets

 

Once daily

Once weekly

Once monthly

Self-administered injections

Self-administered injections

 

Once daily

Intravenous infusion

Intravenous infusion

 

Once yearly

Osteoporosis treatment

Frequency of dosing
Prolia® injections administered by a healthcare professional Once every
6 months
Oral bisphosphonate tablets

Once daily

Once weekly

Once monthly
Self-administered injections

Once daily
Intravenous infusion

Once yearly

Help maintain the effects of Prolia® by continuing to take Prolia® once every 6 months as directed by your doctor

You should take calcium and vitamin D as your doctor tells you to while you receive Prolia®.

In females who are able to become pregnant, your healthcare provider should do a pregnancy test before you start Prolia®. 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®.

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. Do not stop, skip or delay taking Prolia® without first talking with your doctor.

A woman taking a photo

Learn how Prolia® works

Find out how the targeted treatment Prolia® stops the development of bone-removing cells.

DISCOVER HOW

Cost support for Prolia®

What you pay for Prolia® depends on your insurance plan.

SEE INSURANCE TYPES
A man looking at his smartphone

Benefits of Prolia® for cancer treatment-induced bone loss

Benefits of Prolia® for cancer treatment-induced bone loss

Prolia® is a treatment for people at high risk for fracture receiving certain treatments for cancer

Hormone-blocking therapy for breast or prostate cancer

could result in bone loss and a high risk for fracture

For people at high risk for fracture receiving certain treatments for cancer, hormone-blocking therapy for cancers of the breast and prostate can result in bone loss in women and men

Talk to your doctor to see if Prolia® is right for you

Prolia® is a prescription medicine approved by the FDA for cancer treatment-induced bone loss

Women with breast cancer

A clinical study measured the lumbar spine bone density in over 250 women with breast cancer on an aromatase inhibitor (AI) therapy taking either Prolia® or a placebo.

Prolia® is proven to help:

Increase bone density in women at high risk for fracture receiving hormone-blocking therapy (known as an aromatase inhibitor) for breast cancer
In women with breast cancer, Prolia<sup>®</sup> was shown to increase bone density by 5.5% after 1 year.
 

After 1 year, Prolia® increased bone density by 5.5%*

*Bone mineral density (BMD) of lumbar spine.

In other locations, BMD also increased.

Men with prostate cancer

A separate 3-year clinical study compared Prolia® to a placebo in over 1300 men with prostate cancer receiving androgen-deprivation therapy (ADT). It evaluated the change in bone density at 2 years of treatment and the rate of fractures at 3 years of treatment.

Prolia® is proven to help:

Increase bone density in men at high risk for fracture receiving hormone-blocking therapy (known as an androgen-deprivation therapy) for prostate cancer that has not spread to other parts of the body
Lower risk of vertebral fracture
In men with prostate cancer, Prolia<sup>®</sup> was shown to reduce the risk of new vertebral fractures by 62%.
 

Prolia® reduced the risk of new vertebral fractures by 62%†

†Relative risk reduction at 3 years. Absolute risk reduction was 2.4% lower incidence of fractures in the people treated with Prolia®, compared to those on placebo.

Prolia® is an injection given at your doctor's office once every 6 months

You should take calcium and vitamin D as your doctor tells you to while you receive Prolia®.

In females who are able to become pregnant, your healthcare provider should do a pregnancy test before you start Prolia®. 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®.

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. Do not stop, skip or delay taking Prolia® without first talking with your doctor.

A woman taking a photo

Learn how Prolia® works

Find out how the targeted treatment Prolia® stops the development of bone-removing cells.

DISCOVER HOW

Cost support for Prolia®

What you pay for Prolia® depends on your insurance plan.

SEE INSURANCE TYPES
A man looking at his smartphone
Close

Important Safety Information

What is the most important information I should know about Prolia®?
If you receive Prolia, you should not receive XGEVA® (denosumab). Prolia contains the same medicine as XGEVA®.
Prolia® can cause serious side effects (including):
Increased risk of severe low calcium levels in your blood (hypocalcemia). Prolia may lower the calcium levels in your blood. If you have low blood calcium before you start receiving Prolia, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia. Talk to your doctor before starting Prolia. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Prolia. Take calcium and vitamin D as your doctor tells you to.
If you have advanced chronic kidney disease (may or may not be on kidney dialysis), Prolia may increase your risk for severe low calcium levels in your blood, which could result in hospitalization, life-threatening events and death. A mineral and bone disorder associated with kidney disease called chronic kidney disease mineral bone disorder (CKD-MBD) may increase your risk for severe low calcium levels in blood. Before you start PROLIA and during treatment, your doctor may need to do certain blood tests to check for CKD-MBD.
Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
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.
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.
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®.
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).

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. 

Please see Prolia® full Prescribing Information and Medication Guide.

Important Safety Information

What is the most important information I should know about Prolia®?
If you receive Prolia, you should not receive XGEVA® (denosumab). Prolia contains the same medicine as XGEVA®.
Prolia® can cause serious side effects (including):
Increased risk of severe low calcium levels in your blood (hypocalcemia). Prolia may lower the calcium levels in  
Read More