Radium-223 Shortage Due to Production Issue

October 16, 2014

The prostate cancer drug radium-223 (Xofigo®) is temporarily unavailable due to a manufacturing issue. The FDA Drug Shortage website indicates that the drug shortage was first reported October 7.

Xofigo is used for use in men with symptomatic metastatic castration-resistant prostate cancer that has spread to the bone but not to other organs. It is intended for men whose cancer has spread after medical or surgical therapy to lower testosterone.

According to an article on OncLive, Bayer said fibrous particles were found in the drug during a routine inspection process, so they have suspended distribution until the issue is resolved, and they do not yet know when they will be able to resume distribution.

A notice on Bayer HealthCare’s Xofigo site says “Healthcare providers or patients with any questions about the Xofigo® (radium Ra 223 dichloride) drug shortage should contact the Bayer Call Center at: 1-888-84-Bayer, or 1-888-842-2937.”

SNMMI will post updates as they become available.