Indications  

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

Prolia® is a prescription medicine used to increase bone mass in men with osteoporosis who:

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One shot of Prolia® (denosumab) every six months is proven to help women with postmenopausal osteoporosis at high risk for fracture strengthen their bones.

Prolia® is a prescription medicine used to treat osteoporosis (thinning and weakening of bone) in women after menopause who:

  • are at high risk for fracture, meaning women who have had a fracture related to osteoporosis, or who have multiple risk factors 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; 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®. 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.

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

Download a brochure about Prolia®

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

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

MALE OSTEOPOROSIS

Did you know men can suffer from osteoporosis?

Learn how Prolia® may help

Already Taking Prolia®?

If you’re already taking Prolia®, it’s important to receive your dose on schedule, every 6 months, to help strengthen your bones and reduce your risk for fracture. By joining the Prolia® Patient Support Program, you will receive a FREE kit with tips for managing your condition and treatment reminders to help you stay on track. Yes, I want my FREE kit. 

Benefits of Prolia®

Prolia® significantly reduces fractures of the spine, hip, and other bones

How Prolia® Works

Only Prolia® helps strengthen bones with 1 shot every 6 months*

Stay on Track

Join the Prolia® Patient Support Program to get the support you need

Eligible patients may pay as low as $25 or less for 1 shot of Prolia®

Learn about co-pay, insurance, and financial support

*Taken with calcium and vitamin D.

Important Safety Information Close

Do not take Prolia® (denosumab) 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 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
  • 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 who are 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, meaning women who have had a fracture related to osteoporosis, or who have multiple risk factors for fracture
  • 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, meaning men who have had a fracture related to osteoporosis, or who have multiple risk factors for fracture
  • cannot use another osteoporosis medicine or other osteoporosis medicines did not work well
See More
Important Safety Information Do not take Prolia® (denosumab) 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: