Prolia® is a prescription medicine used to treat osteoporosis (thinning and weakening of bone) in women after menopause who:
Have an increased risk for fractures (broken bones).
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 been told by your doctor that your blood calcium level is too low. You should take calcium and vitamin D as your doctor tells you to while you receive 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:
Low calcium levels in your blood (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®.
Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood. Take calcium and vitamin D as your doctor tells you to.
Serious infections. 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. Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.
Severe jaw bone problems (osteonecrosis). Severe jaw bone problems 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®
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 or unusual fractures. 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.