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. Read More

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

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Benefits of Prolia®

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What to expect with Prolia®

Prolia® (denosumab) has been approved since 2010 and is proven to help increase bone density and protect bones from fracture.

Prolia® helps strengthen bones by stopping cells that damage them.

Click here to see how Prolia® works

Why Prolia®?

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 7,393 patients who received either Prolia® or a placebo (a treatment containing no medicine).

Prolia® helps strengthen bones with 1 shot every 6 months in your doctor’s office

  • 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.

Download a brochure about Prolia®

Read about postmenopausal osteoporosis and how Prolia® (denosumab) can help

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If you do not have Adobe® Reader®, you can download it for free.

Safety considerations:

  • Prolia® can cause serious side effects.
  • Possible serious side effects include serious allergic reactions, low blood calcium, severe jaw bone problems, unusual thigh bone fractures, increased risk of broken bones, including broken bones in the spine, after stopping Prolia®, serious infections, skin problems, and severe bone, joint, or muscle pain.
Need help talking to your doctor?

Prepare for your next appointment with this helpful questionnaire

"Every year, my doctor tells me that my scans are showing improvement in my bone density score."
– Anita, actual Prolia® patient since 2011
Important Safety Information Close

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).

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

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

See More
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: