denosumab

Prolia

NEW WARNING

The FDA released a Drug Safety Communication to alert health care providers and patients on dialysis that denosumab may increase the risk of hypocalcemia. Severe and symptomatic hypocalcemia, including episodes requiring hospitalization and leading to death, have occurred. Prescribers should consider the risks of hypocalcemia before use in this patient population. Adequate calcium and vitamin D supplementation and frequent blood calcium monitoring may help decrease the likelihood or severity of these risks.

Patients on dialysis should be advised to immediately seek help if they experience symptoms of hypocalcemia such as unusual tingling or numbness in the hands, arms, legs, or feet; painful muscle spasms or cramps; laryngeal or lung spasms causing difficulty breathing; vomiting; seizures; or irregular heart rhythm.

Adverse effects from the use of denosumab 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: January 2023

Nursing Drug Handbook

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