![]() ![]() The absorbed radiation doses in major organs were calculated based on clinical biodistribution data in five patients with castration-resistant prostate cancer. The gamma radiation associated with the decay of radium-223 and its daughters allows for the radioactivity measurement of Xofigo and the detection of contamination with standard instruments. Any unused product or materials used in connection with the preparation or administration are to be treated as radioactive waste and should be disposed of in accordance with local regulations. In keeping with the As Low As Reasonably Achievable (ALARA) principle for minimization of radiation exposure, it is recommended to minimize the time spent in radiation areas, to maximize the distance to radiation sources, and to use adequate shielding. The external radiation exposure associated with handling of patient doses is expected to be low, because the typical treatment activity will be below 8,000 kBq (216 microcurie). The fraction emitted as beta-particles is 3.6%, and the fraction emitted as gamma-radiation is 1.1%. Radium-223 is primarily an alpha emitter, with a 95.3% fraction of energy emitted as alpha-particles. Clothing soiled with Xofigo or patient fecal matter or urine should be washed promptly and separately from other clothing. ![]() When handling bodily fluids, simply wearing gloves and hand washing will protect caregivers. Whenever possible, patients should use a toilet and the toilet should be flushed several times after each use. The dose calibrator must be calibrated with nationally recognized standards, carried out at the time of commissioning, after any maintenance procedure that could affect the dosimetry and at intervals not to exceed one year. Immediately before and after administration, the net patient dose of administered Xofigo should be determined by measurement in an appropriate radioisotope dose calibrator that has been calibrated with a National Institute of Standards and Technology (NIST) traceable radium-223 standard (available upon request from Bayer) and corrected for decay using the date and time of calibration. The Decay Correction Factor Table includes a correction to account for the 7 hour time difference between 12 noon Central European Time (CET) at the site of manufacture and 12 noon US CST, which is 7 hours earlier than CET. To determine the decay correction factor, count the number of days before or after the reference date. Click here for more information.The Decay Correction Factor Table is corrected to 12 noon Central Standard Time (CST). Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. and Bayer will co-promote Xofigo in the U.S., while Bayer has licensed the full rights to the drug outside of the U.S. Under the pharma partners’ 2009 agreement, Algeta U.S. ![]() Male patients receiving Xofigo lived a median of 14 months compared to 11.2 months for those on placebo.Īlgeta President and CEO Andrew Kay said he the EU approval is expected to kick-start a royalty stream for the Norwegian drugmaker. The approval is partially based on the Phase III ALSYMPCA trial, a randomized, double-blind, placebo-controlled international study of 921 men with symptomatic CRPC. The drug, with its alpha-particle-emitting radioactive therapeutic agent, binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues, according to FDA officials. In the EU, Xofigo (radium RA 223 dichloride) is approved for adults with castration-resistant prostate cancer and bone metastases but without visceral metastases. to treat castration-resistant prostate cancer (CRPC) that has spread to bones but not other organs. ![]() The European Commission has granted marketing approval for Bayer and Algeta’s Xofigo, six months after the drug was approved in the U.S. ![]()
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