Important Safety Information
Before starting treatment with Prolia®, tell your doctor about any medications you’re taking. Your doctor will also need to know your medical history, including if you:
- Have low blood calcium levels
- Plan to have dental surgery
- Cannot take calcium or vitamin D supplements
- Have kidney problems
- Are pregnant or planning to become pregnant
- Had thyroid surgery
- Have been told your intestines do not absorb minerals
What is the most important information I should know about Prolia®?
If you are undergoing treatment with Prolia®, you should not receive XGEVA (which also contains denosumab), zoledronic acid, Forteo, Boniva, or Actonel while taking Prolia. You should talk to your doctor before making an appointment to receive Prolia®.
Prolia® Side Effects
As with any prescription medication, Prolia® has a risk of side effects. The most common include infections, back pain, bone, joint or muscle pain, jaw bone problems, low blood calcium, thigh bone fractures, and broken bones on the spine after stopping treatments.
Low Blood Calcium
Do not take Prolia® if you have low blood calcium — since Prolia® may lower the calcium levels in your blood. Avoid treatment if you are pregnant or are planning on becoming pregnant — as the medication may harm the fetus.
Severe Jaw Bone Problems
Since Prolia® may cause osteonecrosis of the jaw, it is crucial to visit the dentist prior to starting treatment. You’ll need a thorough examination and recommendations for good mouth care. Prior to any future dental appointments, you are encouraged to notify your dentist you received Prolia.
Serious Allergic Reactions
It is also possible to experience a serious allergic reaction from Prolia®. Seek emergency medical care if you experience trouble breathing, throat tightness, a rash, itching, hives, or swelling of your face, lips, or tongue.
Thigh Bone Fractures
Prolia® may cause patients to experience unusual fractures in their femurs. Symptoms include pain along the thighs that may radiate to the hip and/or groin.
Prolia® may cause infections of the skin, ear, abdomen, or bladder. It is also possible for the medication to cause inflammation of the inner lining of the heart. Prolia® may also affect the body’s ability to fight infections.
Risk of Fractures
Prolia® may cause an increased risk of fractures on patients who have previously experienced fractures. It’s also possible for individuals to fracture their spine after stopping treatment.
Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.
Females Who Are Able To Become Pregnant
- Your healthcare provider should do a pregnancy test before you start treatment with Prolia®.
- You should use an effective method of birth control (contraception) during treatment with Prolia® and for at least 5 months after your last dose of Prolia®.
- Tell your doctor right away if you become pregnant while taking Prolia®.
- Tell your doctor if you are breastfeeding or plan to breast-feed.
Prolia® is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medications did not work well.
Prolia® is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture. Prolia® is a prescription medicine used to treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least six months and are at high risk for fracture.
Prolia® is a prescription medicine used to treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body. It’s also a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.