Learn about the importance of preventing bone problems with XGEVA® in patients with bone metastases from solid tumors
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About XGEVA®
- XGEVA® (denosumab) is a prescription medicine used in patients with bone metastases from solid tumors to prevent bone problems, such as broken bones (fractures), surgery to repair broken bones, radiation treatments to relieve bone pain, 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
Indication
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 tumors.
XGEVA® is not used to prevent these bone complications in patients with multiple myeloma.
Safety Considerations
Do not take XGEVA® if you are allergic to denosumab or any of its ingredients. XGEVA® can significantly lower the calcium levels in your blood and some deaths have been reported. Severe jaw bone problems and unusual thigh bone fracture have been reported. You should not become pregnant while taking XGEVA®.
Important Safety Information
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Indication
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
tumors.
XGEVA® is not used to prevent these bone complications in
patients with multiple myeloma.
Important Safety Information
Do not take XGEVA® if you are allergic to denosumab or any of the ingredients of XGEVA®.
What is the most important information you should know about XGEVA®?
Low calcium levels in your blood
(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.
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®.
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 or plan to become pregnant. XGEVA® can harm your unborn baby.
Before taking XGEVA®, tell your doctor if you:
- Have low blood calcium
- Cannot take daily calcium and vitamin D
- Have kidney problems or are on kidney dialysis
- Plan to have dental surgery or teeth removed
- Are pregnant or plan to become pregnant
- Are breast-feeding or plan to breast-feed
- Are taking a medicine called Prolia® (denosumab)
What are the possible side effects of
XGEVA®?
The most common side effects of XGEVA® are
tiredness/weakness, low phosphate levels in your blood, and nausea.
The most common serious side effect of XGEVA® is
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.
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