Alpharadin (radium-223)

///Alpharadin (radium-223)

Quality Control Of Xofigo – Confirming That Intravenous Radium-223 Actually Becomes Systemic and Doesn’t Leak At The Injection Site

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 must successfully circulate through out the body to be able to find all of the metastases. A recent study evaluated the ability of the intravenous introduction of the Xofigo to properly circulate through the body.

The researchers relied on the fact that Xofigo in addition to the therapeutic alpha radiation also generates photons that can be imaged with a conventional gamma camera. By using a gamma camera they were able to evaluated real-time the systemic circulation and also exclude Xofigo extravasation at the injection site.

The researchers imaged fifteen Xofigo administrations. They performed dynamic imaging of […]

NICE Reverses Its Decision and Now Recommends Radium-223 (Xofigo) For Men Who Have Had Chemotherapy

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 (castrate resistant prostate cancer) that has also spread to the bones. However, they only recommend it for these men if they’ve already been treated with chemotherapy.

The Scottish Medicines Consortium (SMC), which operates independently of NICE, hasn’t yet considered radium-223 availability on the NHS in Scotland. So at the moment men north of the border still are not able to have this treatment.

Radium-223 is given by injections into the vein, where it travels in the blood system and then finds its way to the bones. It mimics calcium and is taken up by active bone cells and since the cancer cells […]

A New Plant to Manufactor Radium-223 Dichloride (Xofigo) Is Scheduled To Be Built

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 just continue to wait for the problem’s resolution or to move on to a different drug. When the problem was resolved there was no evidence based information that could guide men if they should just start taking their Xofigo where they left off or perhaps attempt to start the protocol again from the beginning.

In reality we will never know what was the best course nor what the actual result of the shortage of the drug wil be for the men who missed their treatment.

Yesterday there was a joint media release from Bayer HealthCare […]

Xofigo Pricing To Change With Patient Costs To Be Reliant On Weight Sensitive Dosages

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 from the following determinations from the Centers for Medicare & Medicaid Services (CMS).

• CMS has assigned a new permanent Healthcare Common Procedure Coding System (HCPCS) code to Xofigo. This code, A9606 (Radium ra-233 dichloride, therapeutic, per microcurie) will become effective this January 1, 2015. The code is mandated by CMS and is specifically designed to facilitate automated billing and reimbursement by the doctors and hospitals.

• Prior to the assignment of this code Xofigo was purchased and reimbursed at a […]

Xofigo To Again Be Available to New Patients with Metastatic Prostate Cancer

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 that they had shut down the complete production of Xofigo and would run out of any available product by October 10, 2014. Bayer told us that individual batches of the Xofigo had been inspected as part of their routine quality control process and found that at least two batches of the product contained fibrous material that should not have been present in the drug.

On October 31, 2014 Bayer informed Malecare that they had identified the problem and devised a process to mediate it. They projected that product would again be available for patients in the United […]

Bayer’s efforts to insure safety and restore Xofigo production

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 batches, comprehensive maintenance and cleaning activities, inspection of stoppers and packaging materials, as well as implementation of a temporary release procedure including a modified visual inspection process. In addition to the measures taken at the production facility, Bayer is also implementing a filtration process at Cardinal Health (where the patient ready doses are prepared for use in the clinics.”
We’re encouraged by Bayer’s renewed commitment to keeping patients informed.

By |November 4th, 2014|Xofigo|0 Comments