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Amgen’s Prolia Boxed Warning On Hypocalcemia Risk Backed By Medicare Data

 
• By Sue Sutter

Newly expanded warning language on denosumab for advanced CKD emphasizes appropriate patient selection and need to closely monitor calcium levels. Boxed warning follows FDA drug safety communication in 2022 about hypocalcemia and two observational studies using CMS data.

Calcium test
A new boxed warning on Prolia labeling focuses on the risk of hypocalcemia in patients with kidney disease. • Source: Shutterstock

The US Food and Drug Administration's decision to elevate longstanding warning language on the risk of hypocalcemia with Amgen, Inc.’s bone strengthening drug Prolia (denosumab) to a boxed label warning grew out of two agency studies using Medicare claims data and a review of adverse event reports.

Prolia labeling, which has carried warning language about the risk of low blood calcium levels since the osteoporosis drug’s 2010 approval, now has a boxed warning about the risk of severe hypocalcemia in patients with advanced chronic kidney disease. (See box

Prolia Boxed Warning

  • Patients with advanced chronic kidney disease (eGFR <30 ml/min/1.73="" m2),="" including="" dialysis-dependent="" patients,="" are="" at="" greater="" risk="" of="" severe="" hypocalcemia="" following="" prolia="" administration.="" severe="" hypocalcemia="" resulting="" in="" hospitalization,="" life-threatening="" events="" and="" fatal="" cases="" have="" been="" reported.="">

  • The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients

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