Apparently a problem in the manufacturing process for radium-223 dichoride (Xofigo) at the only plant where the drug is made (in Norway) has required that the plant be temporarily shut down. The supply of radium Ra-223 will run out tomorrow (October 10, 2014) for all current and new patients, worldwide.
We thank Malecare for bringing this problem to our attention.
A spokesperson for Bayer (the manufacturer) is quoted as stating that:
At this time, Bayer is unable to anticipate when distribution of Xofigo can be resumed.
The U.S. Food and Drug Administration (FDA) first announced this predicted shortage in production of radium-223 on Tuesday this week, but as yet there appears to have been no formal statement from Bayer that we can find on line.
Apparently, Bayer assured Malecare that any drug received by anyone to date is safe and meets all quality standards and that patients currently being treated with radium-223 should contact their physicians to discuss what, if any, alternative treatments might be appropriate at the present time. Some additional information is available on the Malecare web site.
Radium-223 dichloride was recently approved by the FDA for treatment for men with castrate-resistant prostate cancer (CRPC) with bone metastases but without any known visceral metastases.
Filed under: Management, Treatment | Tagged: radium-223, Xofigo |
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Just an update …
I met with Dr. Joseph Germino today at the NASPCC conference in Washington, DC. I get the impression that Xofigo could be off the market for some considerable time. I asked him point blank when will this get resolved and the answer indicated at least a month. The half-life of radium-223 is 11 days and with the plant closed still today and for possibly more than a couple more weeks, and considering the time it takes to import the drug, this would at very least indicate November at the earliest before we see it again back on the market in the US. Dr. Germino agreed that would likely be the case. I tried to pry into the specifics as to what “foreign” contamination was found and Dr. Germino was not willing or was unable to answer.
Clearly this is a major worry for people on Xofigo. I was due an injection on Wednesday and it is frustrating that Bayer seems to be saying nothing … or if they are saying something I cannot find it. If anyone has news I would certainly like to hear it
Robin: Try calling 01 635 563000. That’s Bayer Pharma’s main number in the UK.