Patients with advanced kidney disease on dialysis who are treated with Prolia (denosumab) may be at risk of severe hypocalcemia with serious outcomes (eg, hospitalization and death), according to a drug safety communication from the Food and Drug Administration (FDA).

The FDA approved Prolia, a receptor activator of nuclear factor kappa beta, in June 2010 for the treatment of postmenopausal women with osteoporosis at high risk for bone fracture. Subsequently, Prolia was also approved for the treatment of men with osteoporosis, glucocorticoid induced osteoporosis, bone loss in men receiving androgen deprivation therapy for prostate cancer, and in women receiving aromatase inhibitor therapy for breast cancer. 

When Prolia was initially approved, Amgen was required to conduct a long-term safety study in women with postmenopausal osteoporosis and men with osteoporosis. An FDA review of interim results suggested that patients with advanced kidney disease demonstrated an increased risk of hypocalcemia when treated with Prolia. Moreover, adverse event reports of severe and symptomatic hypocalcemia, including hospitalization and death, were submitted to the FDA.

Additionally, the FDA conducted a separate internal study to investigate the risk of hypocalcemia in this patient population. Preliminary results showed that treatment with Prolia in dialysis patients had a substantial risk for severe and symptomatic hypocalcemia, including hospitalization and death.

Health care professionals are advised to consider the risks of hypocalcemia when using Prolia in dialysis patients. In order to decrease the risk or severity of hypocalcemia when Prolia is used in these patients, health care professionals should ensure adequate calcium and vitamin D supplementation and frequent monitoring of blood calcium. Patients should consult their health care professional regarding any concerns, including treatment discontinuation and possible alternative treatments.

Adverse events related to Prolia or other medicines should be reported to the FDA’s MedWatch program.

Reference

FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab). News release. US Food and Drug Administration. Accessed November 22, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-investigating-risk-severe-hypocalcemia-patients-dialysis-receiving-osteoporosis-medicine-prolia