The world wide supply of Xofigo (radium Ra-223 dichloride) available for patients will run out on October 10, 2014. Xofigo is the newly FDA approved treatment for men with castrate resistant metastatic prostate cancer (CRPC) with bone metastases without any known visceral metastases.
Individual batches of drugs are inspected prior to release to patients. Bayer’s regular inspection process found that two batches contained material unrelated to Xofigo.
The FDA posted a notice about a Xofigo shortage on October 7, 2014. Malecare obtained more information from Ms. Gissoo Decotis, Deputy Director of Oncology Advocacy Relations and Joseph Germino, MD, PhD, Vice President of United States Medical Affairs for Bayer HealthCare, LLC.
Dr. Germino assured Malecare that all doses of Xofigo that have been released to either their commercial patients or to men in clinical trials, have passed all inspections and are completely safe. Dr. Germino said, “patients should not be worried or concerned about the quality of the material that has been shipped or administered. “
Bayer is in the process of informing all physicians who do administer Xofigo about the production halt, said Ms. Decotis. If you are a man currently taking Xofigo or are interested in starting Xofigo, contact your doctor today.
In a way, this is good news. The drug inspection and safety process seems to work. Bayer not only seems to have acted quickly, but is keeping Malecare informed so that we can keep you informed. The bad news is that as of today, no one at Bayer knows what caused this contamination, according to Ms. Decotis. Some men might not receive Xofigo on schedule and others will need to delay their treatment. Indeed, some…if not, many, men…might not live long enough to see the supply replenished.
The length of time it will take for Bayer to resolve the problem and then to restart production will be of concern to men who have partially completed the protocol. Xofigo is delivered as an injection into a vein once a month (every 28 days) over a six month period for a total of six injections. Ms. Decotis reports that the total shelf life of radium-223, the main component of Xofigo, is approximately four weeks and its half-life is approximately 11 days.
Paragraph removed. Please click here to see October 10 posting explaining why.
According to Ms. Dicotis, Bayer’s statement is, “At this time, Bayer is unable to anticipate when distribution of Xofigo can be resumed.”
Xofigo is manufactured by only one plant, in Norway.
BOTTOM LINE
1- Bayer has assured us that any drug received by anyone to date is safe and meets all quality standards.
2- How long this production shut down will last is unknown.
3- Men in the middle of receiving Xofigo should contact their physicians to discuss what, if any, alternative treatments might be appropriate at the present time.
Malecare will continue to monitor the situation and make sure that all of our readers are kept fully informed as we learn more about this situation.
Joel T. Nowak, M.A., M.S.W. and
Wendy A. Lebowitz, Ph.D., M.P.H.
Joel,
I have my 3rd dose today at Dana Farber. I called them and they are good to go.
Do you have any hint of how long Bayer will be down after this?
Gary
Gary,
Good that you are scheduled for today. Don’t miss your appointment. It remains impossible to know how long Bayer will be out of production. I am staying on top of this and will continue to report anything I learn. – Joel
What was the contaminant and what are the possible consequences of having been administered contaminated Xofigo?
Gen- I was told that there was some type of fibrous material in the drug. This was detected in two separate batches of product as it went went through the normal inspection process. Bayer has told me that all drug that had been released had completely passed all inspections and was entirely safe. There would be no way to know what problems, if any, could result if there was contamination in any delivered drug. – Joel
Just an update,
I met with Dr. Joseph Germino today in DC. I get the impression that Xofigo could be off 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 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.