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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Prescribing Information | Medication Guide
Important Safety Information | Indications

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® For Postmenopausal Osteoporosis

For women with postmenopausal osteoporosis at high risk for fracture:

Prolia® is proven to:

  • Significantly reduce the risk of fractures of the spine, hip and other bones
  • Help increase bone density
  • Help 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.

Women Women C

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

  • are at high risk for fracture
  • cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.

Prolia® isn't right for everyone. Do not take Prolia® if you: have low blood calcium; are pregnant or plan to become pregnant, as Prolia® may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia®.

Prolia® has been used to treat women with postmenopausal osteoporosis since 2010.

Prolia® Facts

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%).
Reduced Fractures arrow

*Study consisted of 7393 patients who received either Prolia® or placebo (a treatment containing no medicine).

Are you ready to help strengthen your bones?
Talk with your doctor to see if Prolia® is right for you.

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Learn More About
POSTMENOPAUSAL OSTEOPOROSIS AND HOW PROLIA® CAN HELP

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How PROLIA® IS DIFFERENT From Oral Pills

Prolia® is not a pill, so it doesn't go down your esophagus or through your stomach. Prolia® may be an option for patients who cannot tolerate oral osteoporosis pills, or for patients with whom the oral pills do not work well.

Prolia® is the first and only prescription medicine for postmenopausal osteoporosis given as 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.

Questions To Ask Your Doctor

Questions
  • What more can I do to strengthen and protect my bones?
  • What was the result of my last bone density scan?
  • What does the result of my bone density scan or T-score mean?
  • Are my bones getting stronger with my current therapy?
  • After I take my medication, my throat often burns, or I get a sour taste in my mouth. Is there another option?
  • Could Prolia® be right for me?

Are you ready to help strengthen your bones? Talk to your doctor to see if Prolia® is right for you.

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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:

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 Prolia® full Prescribing Information and Medication Guide.