denosumab

Prolia

NEW WARNING

The FDA is requiring the prescribing information for denosumab (Prolia) include a Boxed Warning stating that Prolia increases the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), especially those patients on dialysis. Hypocalcemia resulting in hospitalization, life-threatening events and death have occurred. Chronic kidney disease–mineral bone disorder (CKD–MBD) markedly increases the risk of hypocalcemia.

Symptoms of severe hypocalcemia can include confusion, seizures, irregular heart rhythm, fainting, facial twitching, uncontrolled muscle spasms, or weakness, tingling or numbness. However, some patients may be asymptomatic.

Health care providers should evaluate patients with advanced CKD for CKD–MBD before the start of treatment. Treatment with Prolia in patients with advanced CKD should be supervised by a health care provider with expertise in the diagnosis and management of CKD–MBD. Patients should be prescribed an adequate intake of calcium and vitamin D during treatment and taught to monitor for and report symptoms of hypocalcemia. Calcium levels should be monitored closely, and hypocalcemia corrected prior to and during treatment.

Adverse effects from the use of Prolia should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.

Released: March 2024

Nursing Drug Handbook

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