Type of medicine: osteoporosis treatment; monoclonal antibody
Generic and brand names: denosumab, injection; Prolia
This medicine is given by injection (shots) to treat osteoporosis (loss of bone mass) in postmenopausal women (women who no longer have regular monthly periods). This medicine is given if you have a high risk of bone fracture or other osteoporosis medicines do not work well for you.
It may be used for other conditions as determined by your healthcare provider.
Before taking this medicine, tell your healthcare provider if you have ever had:
Tell your provider the date of your last dental exam and if you are scheduled for dental surgery. You may be at risk of a disease called osteonecrosis of the jaw if you have dental surgery while receiving this medicine.
Females of childbearing age: Talk with your health care provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your health care provider's approval.
Read the Medication Guide when you start taking this medicine and each time you receive an injection.
This medicine is given by a healthcare provider once every 6 months. The shots are given just under the skin on your stomach, upper thigh, or upper arm. Keep all appointments.
If you miss a dose, contact your healthcare provider.
You will need to have blood tests and bone density tests regularly to see how this medicine affects you. Keep all appointments.
See a dentist regularly while receiving this medicine. It is important that you practice good mouth care while receiving this medicine. Talk with your healthcare provider or dentist about this.
Follow your healthcare provider's instructions for taking calcium and Vitamin D supplements.
You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.
If you develop hives, an itchy rash, or peeling skin, contact your provider right away.
This medicine may raise your cholesterol. Talk with your healthcare provider about this.
If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are using this medicine.
Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.
Life-threatening (Report these to your healthcare provider right away). If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).
Serious (report these to your healthcare provider right away): Bone, joint, or muscle pain that is severe and continues; nausea, vomiting, constipation, low energy, or muscle weakness that continues; trouble breathing or cough; severe abdominal pain; chest pain; muscle stiffness, twitching, spasms, or cramps; numbness or tingling in your fingers, toes, or around your mouth; fever or chills; burning or frequent urination; severe skin swelling, redness, blisters, or peeling; itching; pain, numbness, or swelling of the jaw, mouth, or teeth; loose teeth; unexplained swelling.
Other: Dizziness; lightheadedness; constipation; heartburn; gas; headache; trouble sleeping; mild back, arm, or leg pain; swelling, or redness at the injection site.
When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:
If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.
This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.
Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.
Keep all medicines out of the reach of children.
Do not share medicines with other people.