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How Prolia® Works

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It's time women with postmenopausal osteoporosis at high risk for fracture learned about Prolia® (denosumab).

Prolia® is the first and only postmenopausal osteoporosis treatment given as a shot 2 times a year.

Prolia® is the first and only prescription therapy for postmenopausal osteoporosis treatment given as a shot 2 times a year in your doctor's office, taken along with calcium and vitamin D.

Learn More

To understand how Prolia® works, it's helpful to understand how postmenopausal osteoporosis affects your bones.

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 does Prolia® work?

Hear Dr. Schneider explain how Prolia® works

How do you take Prolia®?

Hear Dr. Schneider tell how Prolia® is given

  Read Text Version

How does Prolia® work?

In our bodies, we all have cells that remove bone.

When you have postmenopausal osteoporosis, the number of cells that remove bone is increased, causing you to lose bone at a rate that is too fast.

This leads to the thinning and weakening of your bones, so that they are more likely to break.

Prolia® helps stop the development of bone-removing cells before they can cause bone loss.

Prolia® is the first and only treatment for postmenopausal women with osteoporosis at high risk for fracture that is given as shot, just under the skin, two times a year in your doctor's office.

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®.

Prolia® can cause serious side effects, including serious allergic reactions, low blood calcium, severe jaw bone problems, unusual thigh bone fractures, serious infections, skin problems, and severe bone, joint, or muscle pain.

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

Ask your doctor if Prolia® might be right for you.

  Read Text Version

How do I take Prolia® (denosumab)?

Prolia® is a shot under the skin, given once every 6 months in your doctor's office.

Since it is an injection, and not a pill, Prolia® does not go down your esophagus or through your stomach.

If you're being treated with Prolia®, it is also important that you take daily calcium and vitamin D as directed.

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®.

Prolia® can cause serious side effects, including serious allergic reactions, low blood calcium, severe jaw bone problems, unusual thigh bone fractures, serious infections, skin problems, and severe bone, joint, or muscle pain.

Discuss these and other risks included in the Medication Guide with your doctor.

How To 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.

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:

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.

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® 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.

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.

Indication 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
Full Safety Information and Indication

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®?

Important safety information & Indication