denosumab (Xgeva)

What is the most important information I should know about Xgeva?

This medication guide provides information about the Xgeva brand of denosumab. Prolia is another brand of denosumab used to treat osteoporosis in postmenopausal women who have high risk of bone fracture.

What is denosumab (Xgeva)?

Denosumab is a monoclonal antibody. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

The Xgeva brand of denosumab is used to prevent bone fractures and other skeletal conditions in people with tumors that have spread to the bone.

Xgeva is also used to treat giant cell bone tumor in adults and teenagers with fully matured bone structure.

Xgeva is also used to treat high blood levels of calcium caused by cancer, when other medicines such as pamidronate or zoledronic acid (Zometa) have been used without success.

This medication guide provides information about the Xgeva brand of denosumab. Prolia is another brand of denosumab used to treat osteoporosis in postmenopausal women who have high risk of bone fracture.

Denosumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving Xgeva?

While you are receiving Xgeva, you should not use Prolia, another brand of denosumab.

Tell your doctor if you have kidney disease (or if you are on dialysis).

Denosumab may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

How is Xgeva given?

Denosumab is injected under the skin of your stomach, upper thigh, or upper arm. A healthcare provider will give you this injection.

Xgeva is usually given once every 4 weeks.

Your doctor may have you take extra calcium and vitamin D while you are being treated with denosumab. Take only the amount of calcium and vitamin D that your doctor has prescribed.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving denosumab.

Pay special attention to your dental hygiene. Brush and floss your teeth regularly while receiving this medication. You may need to have a dental exam before you begin treatment with Xgeva. Follow your doctor's instructions.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving Xgeva?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of Xgeva?

• new or unusual pain in your thigh, hip, or groin;
• trouble breathing;
• low red blood cells (anemia) --pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; o
• low levels of calcium in your blood (hypocalcemia) --numbness or tingly feeling around your mouth or in your fingers or toes, muscle tightness or contraction, overactive reflexes.

Common side effects may include:

• feeling weak or tired;
• nausea, vomiting, loss of appetite;
• diarrhea, constipation;
• headache, back pain; or
• pain or swelling in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Xgeva?

Other drugs may interact with denosumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about denosumab (Xgeva).

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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