Bayer Healthcare has announced that they will be resuming production of Xofigo® (radium Ra 223 dichloride) for new patients beginning on Monday, November 17th. Xofigo is the newly FDA approved radiopharmaceutical treatment for men with castrate resistant metastatic prostate cancer (mCRPC) with bone metastases without any known visceral metastases.
On October 8, 2014 Bayer informed Malecare that they had shut down the complete production of Xofigo and would run out of any available product by October 10, 2014. Bayer told us that individual batches of the Xofigo had been inspected as part of their routine quality control process and found that at least two batches of the product contained fibrous material that should not have been present in the drug.
On October 31, 2014 Bayer informed Malecare that they had identified the problem and devised a process to mediate it. They projected that product would again be available for patients in the United States some time in November. On
November 4, 2014 they announced that they had been able to resume production with the initial lots of Xofigo been targeted only for those men who had missed dosages.
Today, Bayer has informed us that there is now enough production that beginning on Monday, November 17th they will be able to supply Xofigo to doctors so that they can again start new patients on the drug.
This has been a long and difficult month and a half for those men who were unable to stay on schedule and for those who had hoped to be able start the treatment. We applaud the fact that this terrible period has finally come to an end so men can again gain the benefit of this drug.
If you have missed a dose and have not arranged to get it immediately speak with your doctor. Men interested in starting the treatment should alos contact their doctor to make sure that you are scheduled.
For further information about Xofigo or the manufacturing issues men should contact their healthcare provider or the Bayer Call Center at 1-888-84-Bayer, or 1-888-842-2937.
Joel T. Nowak, M.A., M.S.W.
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