Denosumab, Injection for Osteoporosis

________________________________________________________________________

KEY POINTS

• This medicine is given by injection to treat osteoporosis. This medicine may also be given to prevent bone problems in people being treated for certain kinds of cancer.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may raise your cholesterol, increase your risk for thigh bone fractures, or cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: osteoporosis treatment; monoclonal antibody

Generic and brand names: denosumab, injection; Prolia

What is this medicine used for?

This medicine is given by injection (shots) to treat osteoporosis (loss of bone mass) in men and postmenopausal women (women who no longer have regular monthly periods). This medicine may also be given to prevent bone problems in people being treated for certain kinds of cancer. This medicine is given if you have a high risk of bone fracture or other osteoporosis medicines do not work well for you.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to latex
• A weakened immune system
• Kidney problems
• Low levels of calcium, magnesium, phosphorus in your blood
• Surgery on your thyroid, parathyroid, or intestines
• Trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)

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: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnancy and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I use it?

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.

What if I miss a dose?

If you miss a dose, contact your healthcare provider.

What should I watch out for?

This medicine may increase your risk for a rare, but severe thigh bone fracture. Contact your healthcare provider right away if you have any new or unusual thigh or hip pain. Talk with your healthcare provider about this.

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, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

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 stomach pain; fast or irregular heartbeat; 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.

What products might interact with this medicine?

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:

• Cancer medicines such as bevacizumab (Avastin), everolimus (Afinitor, Zortress), pazopanib (Votrient), sorafenib (Nexavar), and sunitinib (Sutent)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Denosumab (Xgeva)
• Immunosuppressants such as azathioprine (Azasan, Imuran), basiliximab (Simulect), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)

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.