PROLIA- denosumab injection
Injection, for subcutaneous use
Read the Medication Guide that comes with Prolia before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about 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 including:
Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Prolia. Take calcium and vitamin D as your doctor tells you to.
Serious allergic reactions.
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 reactions. Symptoms of a serious allergic reaction may include:
low blood pressure (hypotension)
swelling of your face, lips, or tongue
Call your doctor right away if you have any of these side effects.
What is Prolia?
Prolia is a prescription medicine used to:
It is not known if Prolia is safe and effective in children.
Who should not take Prolia?
Do not take Prolia if you:
What should I tell my doctor before taking Prolia?
Before taking Prolia, tell your doctor if you:
If you are a man and you receive Prolia: Small amounts of Prolia may be in semen. If your sexual partner is pregnant, some Prolia from your semen may reach the unborn baby. While the risk is likely to be low, it is important to talk to your doctor if your partner becomes pregnant while you are taking Prolia.
Tell your doctor about all the medicines you take, including prescription and nonprescription drugs, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of medicines with you to show to your doctor or pharmacist when you get a new medicine.
How will I receive Prolia?
What are the possible side effects of Prolia?
Prolia may cause serious side effects.
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:
The most common side effects of Prolia in men with osteoporosis are:
The most common side effects of Prolia in patients receiving certain treatments for prostate or breast cancer are:
Tell your doctor if you have any side effect that bothers you or that does not go away.
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 store Prolia if I need to pick it up from a pharmacy?
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
Amgen Manufacturing Limited, a subsidiary of Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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