Prolia

Learn About Prolia

2 shots of Prolia (denosumab) a year are 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. Talk to your doctor to see if Prolia is right for you.

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 of fracture. With the ProliaPlus Patient Support Program, you can receive treatment reminders and helpful tips for living with postmenopausal osteoporosis.

Benefits of Prolia

If you have postmenopausal osteoporosis and are at high risk for fracture—you'll want to learn more about the benefits of Prolia (denosumab).

Prolia is proven to:

  • Protect bone from fracture
  • Increase bone density
  • Make bones stronger

In the largest clinical trial of its kind, Prolia (denosumab) was proven to significantly reduce fractures of the spine, hip, and other bones.*

Patients received either Prolia or a placebo (a treatment containing no medicine).

Prolia facts:

  • Prolia is the first and only prescription therapy for postmenopausal osteoporosis that is given as a shot two times a year in your doctor's office.
  • It's not a pill, so it doesn't go through your stomach.
  • You should take calcium and vitamin D as your doctor tells you to while you receive Prolia.

How Prolia Works

It's time women everywhere learned about Prolia (denosumab).

In the 1990s, scientists reported a discovery that led to a better understanding of how bones work to stay strong. This understanding led to the development of Prolia. To understand how Prolia works, it's helpful to know a little about how postmenopausal osteoporosis affects your bones.

  • There are cells in your body that remove old bone, and other cells that rebuild bone.
  • This ongoing process is part of what keeps your bones strong.
  • After menopause, bone removing cells cause you to lose bone at a rate that is too fast.
  • This can leave you with thinner, weaker bones and put you at risk for breaking a bone.

Prolia helps stop the development of bone-removing cells before they can reach the bones and cause damage.

Ask your doctor about your bone strength and if Prolia is right for you.

How do I take Prolia?

You will receive an injection just under the skin (subcutaneous) two times a year. Your doctor may give you Prolia in your upper arm, your upper thigh, or your abdomen (stomach area).

You should take calcium and vitamin D as your doctor tells you to while you receive Prolia.

It’s important to receive your dose of Prolia on schedule, every 6 months. Join the ProliaPlus Patient Support Program to receive helpful information and reminders to keep you on schedule for your next treatment.

Safety Information and Side Effects

Indication  Prolia (denosumab) 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

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 (denosumab) can cause serious side effects:

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.

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 your immune system. 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.

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.

Before taking Prolia (denosumab), 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 are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.

These are not all the possible side effects of Prolia. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.