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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See how Prolia® works in people with osteoporosis by moving the below bar 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 bone-slider shows how Prolia® works with your body to help stop the development of bone-removing cells.
Interactive bone-slider shows how osteoporosis causes an excess of bone-removing cells in your body, which makes you lose bone faster than your body can rebuild it. This can put you at risk for fracture.
See why doctors have been prescribing Prolia® to help men with osteoporosis at high risk for fracture since 2012
Prolia® significantly reduces fractures, helps increase bone density, and makes bones stronger.
Prolia® significantly reduces fractures, helps increase bone density, and makes bones stronger.
Helps increase
bone density
Helps 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, your risk for breaking bones, including bones in your spine, is increased. Do not stop 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
Icon

Prolia® injections administered by a healthcare professional

 

Once every 6 months

Icon

Oral bisphosphonate tablets

 

Once daily

Once weekly

Icon

Self-administered injections

 

Once daily

Icon

Intravenous infusion

 

Once yearly

Osteoporosis treatment

Icon Prolia® injections administered by a healthcare professional
Icon Oral bisphosphonate tablets
Icon Self-administered injections
Icon Intravenous infusion

Frequency of dosing

Once every 6 months

Once daily

Once weekly

Once daily
Once yearly

Your bone-strengthening journey starts here

Stay informed with the Prolia® Patient Support Program

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

Taking corticosteroids, like prednisone, for over 3 months can reduce bone mineral density (BMD) and may increase your risk of fracture

In fact, compared to those not on an osteoporosis treatment, men and women who continuously used corticosteroids for at least 3 months had up to a

SPINE
FRACTURES*
17X
RISK INCREASE
HIP
FRACTURES*
7X
RISK INCREASE

*Based on a study of adults using corticosteroids >10 mg/day for more than 90 days.

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.

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

Without
treatment

For people with corticosteroid-induced osteoporosis, there is a decrease in bone-forming cells and an excess of bone-removing cells, causing bones to become weak and brittle.

With
Prolia®

Prolia® works by stopping the development of bone-removing cells in the body, before they can reach and damage the bone.

Interactive bone-slider shows how Prolia® works with your body to help stop the development of bone-removing cells.
Interactive bone-slider shows how osteoporosis causes an excess of bone-removing cells in your body, which makes you lose bone faster than your body can rebuild it. This can put you at risk for fracture.
1 year safety study
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 or chronic obstructive pulmonary disease (COPD).

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.

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 were the most common side effects experienced by people taking Prolia®
Most Common Side Effects
Prolia®
(n=394)
Back pain
18 people out of 394
High blood pressure
15 people out of 394
Bronchitis
15 people out of 394
Headache
14 people out of 394
Prolia® requires fewer doses than most other treatments for corticosteroid-induced osteoporosis
Osteoporosis treatment
Frequency of dosing
Icon

Prolia® injections administered by a healthcare professional

 

Once every 6 months

Icon

Oral bisphosphonate tablets

 

Once daily

Icon

Self-administered injections

 

Once daily

Icon

Intravenous infusion

 

Once yearly

Osteoporosis treatment

Icon Prolia® injections administered by a healthcare professional
Icon Oral bisphosphonate tablets
Icon Self-administered injections
Icon Intravenous infusion

Frequency of dosing

Once every 6 months
Once daily
Once daily
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, your risk for breaking bones, including bones in your spine, is increased. Do not stop taking Prolia® without first talking with your doctor.

Find out why bone health is important

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

Prolia® is proven to help
Women with breast cancer

Increase bone mass in women at high risk for fracture receiving hormone blocking therapy (known as an aromatase inhibitor) for breast cancer that has not spread to other parts of the body

Increase bone density
*Bone mineral density (BMD) of lumbar spine. In other locations, BMD also increased.
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.
In women with breast cancer, Prolia® was shown to increase bone density by 5.5% after 1 year.

Prolia® is proven to help
Men with prostate cancer

Increase bone mass 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

Increase bone density

Lower risk of vertebral fracture
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.
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.
In men with prostate cancer, Prolia® was shown to reduce the risk of new vertebral fractures by 62%.

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, your risk for breaking bones, including bones in your spine, is increased. Do not stop taking Prolia® without first talking with your doctor.

Experience the Prolia® difference

See if you are eligible for financial assistance

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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 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:
  • 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
    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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