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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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Your corticosteroid medicine could increase your risk of fracture

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

In fact, compared to those not on a corticosteroid 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.

Keep your bone strength in check before a break happens

Even though you can’t feel it or see it, you may be walking around with osteoporosis as a result of your corticosteroid treatment. It’s important to take care of your bones.

Get a DXA scan to know your T-score

Your T-score defines your bone mineral density (BMD), which lets you and your doctor know how healthy your bones are. Bone mineral density is measured with a DXA scan (sometimes pronounced dexa). This is a fast and pain-free test that determines your T-score.

See how osteoporosis affects your T-score

Talk to your doctor about treatment options

You may need a prescription medicine to help strengthen your bones. Work with your doctor to find the right fit for your lifestyle.

Prolia® is a proven bone-strengthening option

Prolia® is a proven bone-strengthening option

Give your bones a fighting chance

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

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

For women with breast cancer

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

  • Bone loss is a possible side effect of hormone therapy with an AI
  • Bone loss can put women at high risk for fractures
  • Places where bone loss can occur include:
    • Icon Lower back
    • Icon Hip bones
    • Icon Upper thigh bones

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

For men with prostate cancer

A clinical study of men with prostate cancer receiving androgen-deprivation therapy (ADT) measured the change in bone density in those taking Prolia® or placebo.

  • Bone loss is a possible side effect of hormone therapy, or ADT
  • Bone loss can put men at high risk for fractures
  • Places where bone loss can occur include:
    • Icon Lower back
    • Icon Hip bones
    • Icon Upper thigh bones

Prolia® is a proven bone-strengthening option

Strengthening bones starts with the right conversation

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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