Radium-223 dichloride (Xofigo) has been approved as an intravenous radiotherapy for men with castration-resistant prostate cancer (CRPC) who have multiple osseous (bone) metastases. Most often, it is used in men who have too many metastases to treat with spot radiation. Xofigo works by mimicking calcium that is attracted to bones. To be successful the drug [...]
According to Prostate Cancer UK The National Institute for Health and Care Excellence (NICE) has released its second draft decision on the availability of radium-223 (Xofigo). Different from the original draft this draft recommends that radium-223 be made available on the NHS for men with advanced prostate cancer that no longer responds to hormone therapy [...]
A few weeks during a devistating manufactoring problem and eventual shut down of all production many men who were relying on Xofigo (radium-233 dichloride) were put into the untenable position of missing their scheduled doses. There was mass confusion about what to do in this circumstance. Men and their doctors didn't know if they should [...]
As of January 1, 2015 there will be some significant changes in the billing and reimbursement schedule for men receiving Bayer healthcare’s radium Ra223 dichloride (Xofigo). Xofigo is FDA approved for the treatment of men with castration-resistant metastatic prostate cancer (mCRPC) who have symptomatic bone metastases and no known visceral metastatic disease. These changes result [...]
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 received more detail from Ms. Gissoo Decotis, Deputy Director of Oncology Advocacy Relations Bayer HealthCare, LLC. The following is about Bayer's efforts to insure safety and get Xofigo back into the market. "Following extensive root cause analyses, corrective actions at the manufacturing site were put into place. These actions included isolation of the affected [...]
Bayer HealthCare has announced that they have now resumed production of Xofigo (Ra 223 dichloride). Bayer has indicated that an initial lot of Xofigo has already been released so some patients will be able to re-start their treatment as early as this week. Bayer is in the process of contacting treating physicians with the news. [...]
Today, Bayer supplied Malecare with an update about the status of the Xofigo shortage. Bayer has told us that they have identified the cause of the problem and have implemented a system to resolve the problem. They are hopeful that the first batch of drug will able to be released in the month of November, [...]
Day 25 of Xofigo shutdown. We're hearing from men who have lost the opportunity to continue their treatment on schedule. We're hearing from deeply worried spouses. We want to hear from you, too. Malecare continues to investigate. Malecare contacted factory workers at the Bayer plant in Norway. Predictably, they wouldn't answer Malecare's questions about when [...]
Its day 20 since Xofigo production stopped. How are you? Please email Joel at joel@malecare.org about how the Xofigo shutdown has affected your life. Bayer has issued a public statement about the shortage of Xofigo (radium Ra 223 dichloride). After reviewing their statement I find that there is no new information that we haven’t already [...]
