Prolia Warnings and Precautions

Before starting osteoporosis treatment with Prolia, make sure to inform your healthcare provider of any other medications you are taking and any other medical conditions you may have. For example, tell your healthcare provider if you have hypocalcemia, hypoparathyroidism, or severe kidney disease. Prolia warnings and precautions also apply to women who are pregnant or breastfeeding.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to receiving injections of Prolia® (denosumab) 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 Precautions and Warnings With Prolia

Some warnings and precautions to be aware of prior to receiving Prolia include the following:
 
  • Prolia can cause or worsen low blood calcium levels. If you already have low blood calcium, this problem must be corrected before you start Prolia. 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 Prolia should also be taking calcium and vitamin D.
     
  • Studies suggest that Prolia 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), Prolia may not be a good choice for you. Let your healthcare provider know if you develop frequent, persistent, or serious infections while on Prolia.
     
  • Studies suggest that Prolia 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.
 
  • 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.
 
  • As with many other osteoporosis medications, Prolia 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 Prolia.
  • Early studies have suggested that Prolia 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).
     
  • Prolia can potentially interact with other medications (see Prolia Drug Interactions).
     
  • Prolia is considered a pregnancy Category X medication. This means that it is not safe for use during pregnancy (see Prolia and Pregnancy).
     
  • It is not known whether Prolia passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Prolia and Breastfeeding).
     
Pregnancy and Pain

Prolia Medication Information

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