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.
Xgeva is used to prevent bone fractures and other skeletal conditions in people with tumors that have spread to the bone. It is not for use in people with multiple myeloma (bone marrow cancer).
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.
Important information
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.
Do not use Xgeva if you are pregnant. It could harm the unborn baby.
You should not receive Xgeva if you are allergic to denosumab, or if you have low levels of calcium in your blood (hypocalcemia).
Before you receive this medicine, tell your doctor if you have kidney disease or if you are on dialysis.
Some people using Xgeva 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 Xgeva. You may need to stop using the medicine for a short time.
Before receiving Xgeva
You should not receive Xgeva if you are allergic to denosumab or if you have low levels of calcium in your blood (hypocalcemia).
While you are receiving Xgeva, you should not use Prolia, another brand of denosumab.
To make sure you can safely use this medicine, tell your doctor if you have kidney disease (or if you are on dialysis).
Xgeva may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, gum infection, 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.
FDA pregnancy category D. Do not use Xgeva if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.
See also: Pregnancy and breastfeeding warnings (in more detail)
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Xgeva on the baby.
It is not known whether denosumab passes into breast milk or if it could harm a nursing baby. However, this medication may slow the production of breast milk. You should not breast-feed while receiving Xgeva.
How is Xgeva given?
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. Follow your doctor"s instructions.
Your doctor may have you take extra calcium and vitamin D while you are being treated with Xgeva. 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 happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Xgeva injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid?
Follow your doctor"s instructions about any restrictions on food, beverages, or activity.
Xgeva side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Xgeva: itching, rash, hives; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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new or unusual pain in your thigh, hip, or groin;
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fast or slow heart rate, trouble breathing;
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low red blood cells (anemia)- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
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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 Xgeva side effects may include:
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feeling weak or tired;
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nausea, vomiting, loss of appetite;
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diarrhea, constipation;
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headache, back pain; or
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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.
See also: Side effects (in more detail)
What other drugs will affect Xgeva?
Other drugs may interact with Xgeva, 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.
