Brand Name

Xgeva {Amgen}

Generic Name

denosumab, pronounced den OH sue mab

What is Xgeva?

Xgeva helps to prevent bone fractures, as well as other skeletal conditions in people with tumors that have spread to the bone. You should not use Xgeva is if you have multiple myeloma, or bone marrow cancer. As a monoclonal antibody, Xgeva works to target and destroy only certain cells in your body, which helps to protect the healthy cells from damage.

Xgeva may also be used for purposes not indicated in this medication guide.

Key Facts About Xgeva

Some patients who have used medications similar to Xgeva have reported bone loss in their jaw, which is also called osteonecrosis of the jaw. The symptoms of this condition can include jaw pain, swelling, numbness, loose teeth, gum infections or a slow healing after injury or surgery involving your gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer, have been treated with chemotherapy, radiation or steroids, have a blood clotting disorder, anemia or a pre-existing dental problem.

You may need to have a dental exam before taking Xgeva and receive preventative tooth and gum care, especially if you are undergoing chemotherapy, taking steroids or have poor dental health.

You should try and avoid any type of dental surgery while you are being treated with Xgeva, as this medication may cause you to take longer to heal.

Tell your doctor if you are pregnant or plan to become pregnant. Xgeva is in FDA pregnancy category X. Xgeva is known to harm an unborn baby. If you are breastfeeding you should ask your doctor about taking Xgeva. Xgeva may affect a breastfeeding baby as it is not known to pass into breast milk, but is known to slow a nursing mother’s production of breast milk.

Before You Take Xgeva

If you are allergic todenosumab you should not take Xgeva.

You should not take Xgeva if you are pregnant or breast-feeding, have severe kidney disease or have low levels of calcium in your blood.

Xgeva is a brand of denosumab. Prolia is another brand of denosumab used to treat osteoporosis in postmenopausal women who have high risk of bone fracture. This medication guide is only for Xgeva. Tell your doctor if you are taking Prolia before taking Xgeva.

Xgeva Drug Interactions

There are no specific drug interactions known at this time for Xgeva. However, other drugs you take that are not listed may interact with Xgeva. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

Directions for Taking Xgeva

Xgeva is administered by subcutaneous injection and injected in your abdominal wall, thigh, upper arm, or buttocks. A healthcare provider will administer this injection about every four (4) weeks.

You may be prescribed calcium and vitamin D supplements while you are being treated with Xgeva. Take care to follow your doctor’s instructions regarding these supplements.

Xgeva Side Effects

If you experience any of the following adverse effects you should stop taking Xgeva and seek emergency medical help immediately:

• allergic reaction symptoms like breathing difficulties, hives, and swelling of your face, lips, throat or tongue
• heart rate that is too fast or too slow
• muscle spasms, muscle cramps and a numb or tingly feeling, especially around your mouth, fingers or toes
• trouble breathing

Less serious side effects of Xgeva may include:

• diarrhea
• headache
• nausea
• weakness or feeling tired

It should be noted that this is not a complete list of possible side effects of Xgeva. You should contact your physician for a complete list and medical advice regarding these effects.

Xgeva Description and Dosing

Xgeva is recommended as a 120 mg dose, administered as a subcutaneous injection every 4 weeks in the upper arm, upper thigh, or abdomen. Xgeva is available as a 120 mg/1.7 mL (70 mg/mL) single-use vial.

If you suspect that you have overdosed with Xgeva you should seek emergency help immediately.

Ingredients in Xgeva

Xgeva contains the active ingredient denosumab. Other inactive ingredients include sorbitol, acetate, Water for Injection (USP), and sodium hydroxide to a pH of 5.2.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

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