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Learn about the importance of preventing bone problems with XGEVA® in patients with bone metastases from solid tumors
- XGEVA® (denosumab) is a prescription medicine used in patients with bone metastases from solid tumors to prevent bone problems that are broken bones (fractures), surgery to prevent or repair broken bones, radiation treatments to bone, and pressure on the spinal cord (spinal cord compression)
- XGEVA® (denosumab) is given as a single shot under the skin (subcutaneous), once every 4 weeks
- XGEVA® (denosumab) does not involve the use of an infusion through a vein
XGEVA® is a prescription medicine used to
prevent fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with bone metastases from solid
XGEVA® is not used to prevent these bone problems in patients with multiple myeloma.
Important Safety Information
Do not take XGEVA® if you have low blood calcium (hypocalcemia). XGEVA® can significantly lower the calcium levels in your blood and some deaths have been reported. Your low blood calcium must be treated before you receive XGEVA®. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take XGEVA®. Take calcium and vitamin D as your doctor tells you to. Tell your doctor right away if you experience spasms, twitches, cramps, or stiffness in your muscles or numbness or tingling in your fingers, toes, or around your mouth.
Do not take XGEVA® if you are allergic to denosumab or any of the ingredients of XGEVA®. Serious allergic reactions have happened in people who take XGEVA®. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of the face, lips, or tongue, rash; itching; or hives.
What is the most important information you should know about XGEVA®?
XGEVA® contains the same medicine as Prolia® (denosumab). If you are taking XGEVA® do not take Prolia®.
Severe jaw bone problems (osteonecrosis)
- Severe jaw bone problems may happen when you take XGEVA®. Your doctor should examine your mouth before you start, and while you are taking XGEVA®. Tell your dentist that you are taking XGEVA®. It is important for you to practice good mouth care during treatment with XGEVA®. In studies of patients with bone metastases, the rate of severe jaw problems was higher the longer they were being treated with XGEVA®.
Unusual thigh bone fracture
- Unusual thigh bone fracture has been reported. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.
Possible harm to your unborn baby
- You should not become pregnant while taking XGEVA®. Tell your doctor right away if you are pregnant, plan to become pregnant, or suspect you are pregnant. XGEVA® can harm your unborn baby. Women of child bearing age should use highly effective contraception while taking XGEVA® and at least 5 months after the last dose of XGEVA®.
Tell your doctor if you:
- Are taking a medicine called Prolia® (denosumab) because it contains the same medicine as XGEVA®
- Have symptoms of low blood calcium such as muscle stiffness or cramps
- Have symptoms of severe jaw bone problems such as pain or numbness
- Have ongoing pain or slow healing after dental surgery
- Are pregnant, plan to become pregnant, suspect you are pregnant, or breastfeeding
While taking XGEVA®, you should:
- Take good care of your teeth and gums and visit a dentist as recommended
- Tell your dentist that you are taking XGEVA®
- Tell your doctor if you plan to have dental surgery or teeth removed
- Women of child bearing age should use highly effective contraception while taking XGEVA® and at least 5 months after the last dose of XGEVA®
What are the possible side effects of XGEVA®?
- The most common side effects in patients receiving XGEVA® for the prevention of serious bone problems were tiredness/weakness, low phosphate levels in your blood, and nausea. The most common serious side effect of XGEVA® was shortness of breath.
These are not all the possible side effects of XGEVA®. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.