West Reading Radiology Associates and the Section of Nuclear Medicine is pleased to announce the addition of Xofigo to our list of therapeutic offerings. Marketed by Bayer Pharmaceuticals, Xofigo is the trade name for radium 223 dichloride which is an injectable alpha-emitting radioisotope approved for clinical use by the FDA in May 2013. Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease.
FDA approval for Xofigo was based on a phase III clinical trial (ALSYMPCA) which studied 921 men with prostate cancer. Results of the trial showed a statistically significant improvement in overall survival in men treated with Xofigo versus placebo. Those who received Xofigo also reported a better quality of life as measured using a standardized assessment tool. The full article reporting the details of the trial is available in the New England Journal of Medicine, July 17, 2013.
The current dosage recommendation for Xofigo is six injections given at four-week intervals. The most common adverse reactions documented with Xofigo use are nausea, diarrhea, vomiting, and peripheral edema. Hematologic abnormalities include anemia, leukopenia, and thrombocytopenia. As a result, fairly stringent hematological evaluation is required prior to and during Xofigo administration.
Additional detailed product information regarding Xofigo is available on the internet at http://www.xofigo-us.com. |