Prolia may cause serious side effects.

See “What is the most important information I should know about Prolia?”
Long-term effects on bone: It is not known if the use of Prolia over a long period of time may cause slow healing of broken bones or unusual fractures.
The most common side effects of Prolia are:

Back pain
Pain in your arms and legs
High cholesterol
Muscle pain
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 may report side effects to FDA at 1-800-FDA-1088.

How should I handle Prolia if I need to pick it up from a pharmacy?

Keep Prolia in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton.
Do not freeze Prolia.
When you remove Prolia from the refrigerator, Prolia must be kept at room temperature [up to 77°F (25°C)] in the original carton and must be used within 14 days.
Do not keep Prolia at temperatures above 77°F (25°C). Warm temperatures will affect how Prolia works.
Do not shake Prolia.
Keep Prolia in the original carton to protect from light.
Keep Prolia and all medicines out of reach of children.

General information about Prolia

Do not give Prolia to other people even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Prolia. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Prolia that is written for health professionals.

For more information, go to www.Prolia.com or call Amgen at 1-800-772-6436.

What are the ingredients in Prolia?

Active ingredient:  denosumab

Inactive ingredients: sorbitol, acetate, polysorbate 20 (prefilled syringe only), Water for Injection (USP), and sodium hydroxide

What is osteoporosis?

Osteoporosis is a disease in which the bones become thin and weak, increasing the chance of having a broken bone. Osteoporosis usually causes no symptoms until a fracture happens. The most common fractures are in the spine (backbone). They can shorten height, even without causing pain. Over time, the spine can become curved or deformed and the body bent over. Fractures from osteoporosis can also happen in almost any bone in the body, for example: the wrist, rib, or hip. Once you have had a fracture, the chance for more fractures greatly increases.

The following risk factors increase your chance of getting fractures from osteoporosis:

Past broken bones from osteoporosis
Very low bone mineral density (BMD)
Frequent falls
Limited movement, such as using a wheelchair
Medical conditions likely to cause bone loss, such as some kinds of arthritis
Taking steroid medicines called glucocorticoids, such as prednisone
Other medicines that may cause bone loss, for example: seizure medicines (such as phenytoin), blood thinners (such as heparin), high doses of vitamin A
What can I do to treat osteoporosis?

There are many steps you can take to treat osteoporosis. Taking Prolia, along with calcium and vitamin D, may be one option for you.

Amgen Manufacturing Limited, a subsidiary of Amgen