Prostate Cancer Patients Loose Access to Life Extending Drug

NEW YORK - Oct. 14, 2014 - PRLog -- Men with advanced stage prostate cancer now face increased uncertainty about their health. The world wide supply of Xofigo (radium Ra-223 dichloride) available for patients ran out on October 10, 2014. And no one knows when production will start up again. 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. The manufacturer is Bayer Healthcare,  Bayer’s regular inspection process found that two batches contained material unrelated to Xofigo.

Malecare is the worlds leading prostate cancer support and advocacy nonprofit organization. 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.

Some men will 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.  No one knows for certain what a delay in dosing will cause. According to Dr Germino, in an email dated October 9,“we don’t have a lot of data yet on patients with delayed doses.”

Darryl Mitteldorf, LCSW, Executive Director of Malecare, suggests that patients contact their doctors as soon as possible, to discuss the effect of the Xofigo shortage, on thier health.

About Malecare:
Founded in 1998, Malecare is the worlds leading men's cancer survivor nonprofit organization.  More information about Malecare can be found at http://malecare.org