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Precautions and Warnings With Denosumab

To help ensure a safe treatment process with denosumab, make sure your healthcare provider is aware of any other medical conditions you have, such as low blood calcium, severe kidney disease, or underactive parathyroid glands. It is also important to understand the safety precautions with denosumab, such as the warnings of potentially serious infections and possible problems with your jaw.

What Should I Tell My Healthcare Provider Before Taking Denosumab?

You should talk with your healthcare provider prior to receiving injections of denosumab (Prolia®, Xgeva®) if you have:
 
  • Low blood calcium (hypocalcemia)
  • Underactive parathyroid glands (hypoparathyroidism)
  • Had thyroid surgery or parathyroid surgery in the past
  • A digestive problem that causes poor absorption of vitamins and minerals
  • Had part of your intestines surgically removed
  • Severe kidney disease (and/or are on dialysis)
  • Any immune-suppressing condition, such as HIV, AIDS, or cancer
  • Any allergies, including allergies 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.
     
Make sure to tell your healthcare provider about any other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Denosumab Precautions and Warnings

Some warnings and precautions to be aware of prior to receiving your injection include the following:
 
  • Denosumab can cause or worsen low blood calcium levels. If you already have low blood calcium, this problem must be corrected before you start denosumab. People who are at risk for low blood calcium (those with parathyroid, thyroid, digestive, or kidney problems) should have regular blood tests to monitor their calcium, magnesium, and phosphorus levels.
     
  • Every person who receives denosumab for osteoporosis treatment should also be taking calcium and vitamin D. People receiving this medication for cancer-related bone problems may or may not need calcium and vitamin D, depending on their calcium levels (and should check with their healthcare providers before taking such supplements).
     
  • Studies suggest that denosumab may increase the risk of infections, including serious infections. If you have any condition that suppresses the immune system (or if you are taking immune-suppressing medications), denosumab may not be a good choice for you. Let your healthcare provider know if you develop frequent, persistent, or serious infections while on denosumab.
     
  • Studies suggest the denosumab may increase the risk of skin problems such as eczema, dermatitis, and rashes. Most of the time, these skin problems are not specific to the injection area.
     
  • As with many other osteoporosis medications, denosumab has (in rare cases) 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 a 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 denosumab.
  • Early studies have suggested that denosumab slows bone remodeling (the lifelong process wherein older bone is replaced by new bone). It is unknown how this may affect bone healing (such as after a broken bone).
 
  • 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.
 
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Denosumab Drug Information

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