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Brand Names: Xgeva

Generic Name: denosumab (Xgeva) (Pronunciation: den OH sue mab)

• What is denosumab (Xgeva) (Xgeva)?
• What are the possible side effects of Xgeva (Xgeva)?
• What is the most important information I should know about Xgeva (Xgeva)?
• What should I discuss with my healthcare provider before receiving Xgeva (Xgeva)?
• How is Xgeva given (Xgeva)?
• What happens if I miss a dose (Xgeva)?
• What happens if I overdose (Xgeva)?
• What should I avoid while receiving Xgeva (Xgeva)?
• What other drugs will affect Xgeva (Xgeva)?
• Where can I get more information?

What is denosumab (Xgeva) (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 not for use in people with multiple myeloma (bone marrow cancer).

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 are the possible side effects of Xgeva (Xgeva)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• numbness or tingly feeling around your mouth or in your fingers or toes, fast or slow heart rate, muscle cramps or contraction, overactive reflexes; or
• trouble breathing.

Less serious side effects may include:

• feeling weak or tired;
• diarrhea, nausea; or
• headache.

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 is the most important information I should know about Xgeva (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.

You should not receive denosumab if you are allergic to it, or if you have low levels of calcium in your blood (hypocalcemia).

Before you receive this medication, tell your doctor if you have kidney disease or if you are on dialysis.

Some people using denosumab have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving denosumab. You may need to stop using the medicine for a short time.

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