Important Information for Prolia Users with Chronic Kidney Disease

Consult Your Doctor

If you have chronic kidney disease (CKD) and are using Prolia (denosumab), it is crucial to schedule an appointment with your doctor as soon as possible. The FDA has recently highlighted that osteoporosis patients with CKD face a heightened risk of developing dangerously low calcium levels, known as hypocalcemia, when using Prolia. This issue is particularly significant for patients who are on dialysis or who have mineral and bone density disorders.

Do Not Discontinue Medication Without Guidance

It is important not to stop taking Prolia without consulting your healthcare provider. If you are identified as being at risk for hypocalcemia, your doctor can recommend alternative treatments. In many cases, calcium and vitamin D supplements may effectively reduce the risk of developing low calcium levels.

Understanding the Risks of Low Calcium Levels

Low calcium levels can pose serious health risks. According to the FDA’s safety review in 2023, patients with advanced CKD who received Prolia experienced significant health issues, including life-threatening events and fatalities.

Recognizing Symptoms of Hypocalcemia

What to Watch For

The FDA advises patients using Prolia to be vigilant for the following symptoms of hypocalcemia:

– Confusion
– Seizures
– Irregular heart rhythm
– Fainting
– Face twitching
– Uncontrolled muscle spasms
– Weakness, tingling, or numbness in various body parts

Symptoms may not appear until at least two weeks after the injection, with the highest risk of complications occurring between two and ten weeks post-dose, peaking around five weeks.

Seek Immediate Medical Attention

If you begin to feel unwell, even several months after your Prolia dose, it is essential to seek medical attention promptly.

Minimizing Your Risk

Regular Check-ups Are Key

If you are currently receiving treatment with Prolia, it is advisable to have regular check-ups to monitor your calcium and vitamin D levels.

Consult Before Stopping Medication

Do not discontinue Prolia without discussing it with your doctor, as stopping the medication can lead to a high risk of rebound fractures. While hypocalcemia can have severe consequences, most patients can continue with this treatment safely through careful monitoring and medical guidance. Your physician is best positioned to help you weigh the risks associated with low calcium levels against the potential for fractures.

Further Reading

For more detailed information, please refer to the FDA notice: Research C for DE and. FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab). FDA. Published online January 19, 2024. Accessed January 22, 2024. [FDA Notice](https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-increased-risk-severe-hypocalcemia-patients-advanced-chronic-kidney-disease).