Bayer HealthCare has announced that they have now resumed production of Xofigo (Ra 223 dichloride). Bayer has indicated that an initial lot of Xofigo has already been released so some patients will be able to re-start their treatment as early as this week.
Bayer is in the process of contacting treating physicians with the news. Bayer has said that it is targeting the initial drug production to men who have missed doses of Xofigo, with those men who have had the longest delay being the first to receive Xofigo.
They have indicated that at this time they cannot predict when enough additional Xofigo will be available to be able to start new patients on the protocol.
The manufacturing of Xofigo was suspended after quality control inspections found unknown fibrous particles in the drug. Ultimately, they traced the source of the fibrous particles to some of the vial stoppers. Bayer has indicated they have instituted a corrective and preventive program, which includes adding an additional filtration process prior to the drug being released to doctors for patient use.
Malecare is pleased that Bayer has been able to resolve the problem and get production back in process. We believe that Xofigo is a vital, life-extending drug that not only extends life, but also responds to the often-neglected palliative needs of men with advanced prostate cancer who have bone metastases. Many men and their families felt Xfigos absence, so we applaud the steps made by Bayer to bring back Xofigo to the many men in need.
Joel T Nowak, M.A., M.S.W.