• Xgeva is a brand (trade) name for denosumab which may be used to decrease bone breakdown and increase bone density and strength.
• Xgeva (denosumab) is a monoclonal antibody that is used to prevent bone-related events by binding to a protein called RANKL on osteoclasts (the cells that break down bone), inhibiting their formation, function, and survival. This decreases bone breakdown and increases bone density and strength in both the outer layer of bone and the inner spongy layer inside the bone.
• Xgeva belongs to the class of drugs known as monoclonal antibodies.

• Xgeva may be used to prevent bone fractures and other skeletal conditions in people with multiple myeloma and other types of cancer that have spread to the bone.
• May also be used in teenagers whose bone structure is fully mature and in adults to treat giant cell bone tumors.
• Xgeva can lower high blood calcium levels caused by cancer and may be used to do so if other treatments such as pamidronate or zoledronic acid have failed.
• Xgeva is administered by injection under the skin of the upper thigh, abdomen, or upper arm, once every four weeks.
• The dosage of Xgeva does not need to be reduced in people with kidney disease.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Back pain, constipation, muscle pain, pain in the hands or feet, high cholesterol levels, nasal congestion, and bladder infections (in women) are the most common side effects reported with Xgeva.
• Xgeva may exacerbate low calcium levels and has been associated with low energy or low trauma fractures of the femoral shaft. The risk of serious infections may also be increased.
• Skin reactions occur frequently in people receiving Xgeva, and there have been reports of severe incapacitating bone, joint, or muscle pain associated with Xgeva use. Xgeva may suppress bone remodeling.
• Some people being administered Xgeva may require calcium and vitamin D supplements as well.
• Xgeva has been associated with osteonecrosis of the jaw. The risk of osteonecrosis of the jaw is greater in those who have received chemotherapy, radiation, or steroids. A routine oral examination should be completed by a dentist before Xgeva is started.
• Severe allergic reactions have been reported with Xgeva and symptoms have included low blood pressure, shortness of breath, facial and throat tightness, and rash.
• Xgeva may not be suitable for some people including those who are pregnant or with allergic reactions to Xgeva, Prolia, or denosumab.
• Xgeva is only available as an injection; however, people can be taught how to self-administer Xgeva.
• The grey needle cap that fits onto the end of a pre-filled syringe of Xgeva should not be handled by people with latex allergies because it may cause a reaction.
• Xgeva must be stored in the refrigerator until needed for use.
• The risk of fracture, including multiple vertebral fractures, increases when Xgeva is discontinued, and new vertebral fractures have been reported in as little as 7 months following discontinuation. The risk decreases to pretreatment values within 24 months. Bone density returns to pretreatment values within 18 months of the last injection of denosumab. Evaluate the benefits/risks for each patient before starting denosumab. When discontinuing denosumab, consider transitioning to another osteoporosis treatment agent.
• Xgeva is not FDA-approved to treat osteoporosis but another brand of denosumab, called Prolia, is.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Xgeva is usually given every four weeks. Make sure you keep your scheduled appointments with your healthcare provider.
• Extra supplements may need to be taken with Xgeva. Make sure you take your supplements as directed and talk to your doctor or pharmacist if you are unsure about what supplements to take.
• Make sure you have a dental check-up before you start Xgeva. Talk to both your dentist and doctor if you require dental surgery or tooth extraction and you have been administered Xgeva. Keep good oral hygiene and get regular dental check-ups while you are being given Xgeva. Report any oral symptoms such as tooth pain, jaw pain, tooth loosening, or mouth ulcers to your doctor while you are being administered Xgeva.
• Talk to your doctor or seek urgent medical attention (if severe) if you experience symptoms such as dizziness on standing or fainting, shortness of breath, facial and throat tightness, or rash. Report any signs of infection immediately to your doctor.
• Tell your doctor if you experience any thigh or groin pain, muscle cramps or twitches, severe or debilitating muscle pain, or any other adverse effects of concern while you are being administered Xgeva.
• Xgeva should not be administered to women who are pregnant but if you inadvertently become pregnant while being administered Xgeva, tell your doctor immediately.
• Talk to your doctor or pharmacist before taking any other medicines with Xgeva. Prolia also contains denosumab and should not be taken at the same time

• Xgeva concentrations reach a steady level within three to six months.
• Xgeva reduced levels of the bone turnover marker, uNTx/Cr by 82% after one week in patients with breast cancer and bone metastases, and by 75% after five weeks in patients with newly diagnosed multiple myeloma.

Medicines that interact with Xgeva may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Xgeva. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Xgeva include:

• calcimimetic agents such as cinacalcet
• chemotherapy agents, such as cyclophosphamide, methotrexate, or bleomycin
• corticosteroids (such as prednisone or dexamethasone)
• immunosuppressants (such as azathioprine, cyclosporine, or tacrolimus).

Note that this list is not all-inclusive and includes only common medications that may interact with Xgeva. You should refer to the prescribing information for Xgeva for a complete list of interactions.