XGEVA (Denosumab)

What is this medication?

Xgeva 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 multiple myeloma, and 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.

Prolia is another brand of denosumab used to treat osteoporosis in postmenopausal women who have high risk of bone fracture

How should I use this medication?

Xgeva 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 Xgeva. You may need to stop using the medicine for a short time.

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 this medicine. Follow your doctor's instructions.

What if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Xgeva injection.

How should I store this medication?

Keep the vial in the outer carton in order to protect from light. The vial may be left outside the refrigerator to reach room temperature (up to 25°C) before injection. This will make the injection more comfortable. Once your vial has been left to reach room temperature (up to 25°C), it must be used within 30 days.

What are the possible side effects of using this medication?

Get emergency medical help if you have any signs of an allergic reaction to Xgeva:

• itching,
• rash,
• hives;
• difficulty breathing;
• feeling like you might pass out;
• swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• 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; or
• 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.

After you stop using this medicine, tell your doctor if you have symptoms of high calcium levels (hypercalcemia) such as nausea, vomiting, headache, confusion, lack of energy, or tiredness.

Common Xgeva 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 each of your health care providers about all medicines you use now and any medicine you start or stop using.