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Xgeva Warnings and Precautions

Before receiving Xgeva, let your healthcare provider know if you have any allergies, kidney disease, or low blood calcium. Other precautions for using Xgeva safely include warnings of potential complications that may occur, such as osteonecrosis of the jaw, dangerously low blood calcium, and problems in women who are pregnant or nursing.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to receiving Xgeva® (denosumab) if you have:
  • Kidney disease, such as kidney failure (renal failure)
  • Low blood calcium (hypocalcemia)
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding
  • Planning a dental procedure.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings With Xgeva

Some warnings and precautions to be aware of prior to using this drug include the following:
  • Xgeva can cause or worsen low blood calcium levels, which can be quite dangerous. Contact your healthcare provider right away if you have symptoms of this problem, such as:
    • Spasms or twitches
    • Tingling in the fingers or toes
    • Depression or irritability
    • Confusion
    • An irregular heart rhythm (arrhythmia).
  • People with poor kidney function have a higher risk for dangerously low calcium levels with this medication. Extra monitoring will be required.
  • Xgeva has rarely caused a condition called osteonecrosis of the jaw. This is a serious, possibly disfiguring problem in which the bone of the jaw dies.

Often, there are symptoms, such as pain, infection, or loosening of the teeth, but sometimes there are no symptoms until a person notices exposed bone. It seems that people who have dental procedures, such as a tooth extraction, are at higher risk. Make sure to take good care of your mouth and teeth by seeing your dentist frequently.

Let your healthcare provider know right away if you think you may have osteonecrosis of the jaw. A thorough dental examination may be a good idea to check for problems that need to be addressed before you start Xgeva.
  • There have been reports of unusual broken thigh bones in people taking this medication. These fractures typically were not caused by trauma or injury. Let your healthcare provider know if you have unexplained groin, hip, or thigh pain, as these are sometimes signs of thigh fractures.
  • Although no specific Xgeva drug interactions are known, it is thought that Xgeva could react with certain other medications (see Xgeva Drug Interactions).
  • Xgeva is a pregnancy Category D medication. This means that it may not be safe for use during pregnancy (see Xgeva and Pregnancy).
  • It is not known whether Xgeva passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see Xgeva and Breastfeeding).
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