"Radium-223 dichloride, trade name Xofigo (Bayer HealthCare Pharmaceuticals Inc.), is a radiopharmaceutical approved for the treatment of patients with symptomatic bone metastases and no visceral disease from prostate cancer resistant to anti-androgen therapy. The molecule mimics calcium and forms a complex with hydroxyapatite at sites of increased bone turnover. High-energy alpha particles induce cell death by causing double-stranded DNA breaks. The destruction of osteoblasts and osteoclasts at the tumour site potentially disrupts signalling pathways that promote tumour growth, and the release of cellular contents may also promote the native immune response."
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"alpha decay with 95.3% of energy emitted as alpha particles, smaller amounts as beta particles and gamma rays (energy range of 0.01 - 1.27 MeV)"
"Patients undergoing this therapy undergo laboratory testing before each treatment. Required baseline lab values before undergoing the first treatment are an absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and haemoglobin ≥ 10 g/dL. Between Xofigo treatments, the absolute neutrophil count should be ≥ 1 x 109/L and the platelet count ≥ 50 x 109/L. Supportive care (tranfusions) may be given between treatments. However, if serum lab values do not recover, it is recommended that treatment be discontinued."
"Patients undergoing this therapy undergo laboratory testing before each treatment. Required baseline lab values before undergoing the first treatment are an absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and haemoglobin ≥ 10 g/dL. Between Xofigo treatments, the absolute neutrophil count should be ≥ 1 x 109/L and the platelet count ≥ 50 x 109/L. Supportive care (tranfusions) may be given between treatments. However, if serum lab values do not recover, it is recommended that treatment be discontinued."
"Patients undergoing this therapy undergo laboratory testing before each treatment. Required baseline lab values before undergoing the first treatment are an absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and haemoglobin ≥ 10 g/dL. Between Xofigo treatments, the absolute neutrophil count should be ≥ 1 x 109/L and the platelet count ≥ 50 x 109/L. Supportive care (tranfusions) may be given between treatments. However, if serum lab values do not recover, it is recommended that treatment be discontinued."
"Patients undergoing this therapy undergo laboratory testing before each treatment. Required baseline lab values before undergoing the first treatment are an absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and haemoglobin ≥ 10 g/dL. Between Xofigo treatments, the absolute neutrophil count should be ≥ 1 x 109/L and the platelet count ≥ 50 x 109/L. Supportive care (tranfusions) may be given between treatments. However, if serum lab values do not recover, it is recommended that treatment be discontinued."
"myelosuppression – anaemia, thrombocytopenia, leucopenia"
"Characteristics "
"Ra-223 has a half-life of 11.4 days"
"The phase III ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) randomised controlled trial demonstrated improved overall survival (median of 11.2 months with standard of care versus 14.0 months with radium-223 dichloride in addition) and improved time to first symptomatic skeletal event."
"The REASSURE ((Radium-223 alpha Emitter Agent in Safety Study in mCRPC popUlation for long-teRm Evaluation) trial is a long-term multinational observational study that focuses on the side effects of Radium-223 treatment including secondary primary malignancies as well as overall survival, pain, and fracture incidence. Results thus far (as of August 2023) show that 35% of patients had drug-related adverse events, 1% of which resulted in death. Adverse events included sequela of myelosuppression, most commonly anaemia. Disease progression remained the main cause of death in these patients, highlighting the role of Radium-223 as a symptomatic and not curative therapy. 50% of patients reported a numerical improvement in pain after treatment. Final outcomes are expected in 2024."
"The ERA 223 trial investigated the effects of concurrent use of Radium-223 and prednisone plus abiraterone acetate and found an increased fracture rate (29% versus 11% in the placebo group) and no statistically significant improvement in survival. The results of this trial led to a warning from the FDA and European Medicines Agency against this combined treatment regimen."
"The ERA 223 trial investigated the effects of concurrent use of Radium-223 and prednisone plus abiraterone acetate and found an increased fracture rate (29% versus 11% in the placebo group) and no statistically significant improvement in survival. The results of this trial led to a warning from the FDA and European Medicines Agency against this combined treatment regimen."
"Radium-223 dichloride was FDA-approved in May 2013 for the treatment of patients with symptomatic bone metastases secondary to castration resistant metastatic prostate cancer. In addition, patients must not have visceral metastases."
"Xofigo, previously known as Alpharadin, was developed by Algeta ASA. Algeta was acquired by Bayer in 2013. It is manufactured by Bayer HealthCare Pharmaceuticals Incorporated (Bayer Aktiengesellschaft)."
"Radium-223 dichloride was FDA-approved in May 2013 for the treatment of patients with symptomatic bone metastases secondary to castration resistant metastatic prostate cancer. In addition, patients must not have visceral metastases."
Expected headings
"Characteristics "
"Use "
"Potential side effects "
"History "