Posted 10/9/2014 8:47 AM (GMT -6)
Malecare Advanced Prostate Cancer Program
Patient focused support and advice for men and their families with advanced & recurrent Prostate Cancer
Advanced Prostate Cancer Newsletter
Visit Malecare’s main website for more information
If you find advancedprostatecancer.net valuable, please feel encouraged to visit our main website, http://malecare.org
Xofigo distribution temporarily suspended because of a recently discovered manufacturing problem
The world wide supply of Xofigo (radium Ra-223 dichloride) 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, http://1.usa.gov/1w0HdTi Malecare obtained more information from Ms. Gissoo Decotis, Deputy Director of Oncology AdvocacyRelations and Joseph Germino, MD, PhD, Vice President of United States Medical Affairs for Bayer HealthCare, LLC.
Dr. Germino has 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. And good that 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.
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. The total shelf life of radium-223, the main component of Xofigo, is approximately four weeks and its half-life is approximately 11 days.
Dr. Germino explained to Malecare that this four-week schedule does have some flexibility. During the trial, men were permitted to receive their injections between three days prior to the “due date” to 7 days after the “due date.” Additionally, some patients were allowed to be up to one month later than the “due date”, or to delay an injection from 28 days after a prior injection to as long as 56 days. Dr. Germino said, “30% of the patients in the trial had a delay beyond 28 days.” He also said that based upon a retrospective analysis, “Delayed patients, no matter if the delay was 2 weeks or 4 weeks, showed no difference in survival.”
Not enough patients (only 7) delayed their injections beyond the 56 day mark to allow a statistical analysis of any effect the delay might have had on their survival.
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.
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