"The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for"...
(radium ra 223 dichloride) Intravenous Administration
Radium Ra 223 dichloride, an alpha particle-emitting pharmaceutical, is a radiotherapeutic drug.
Xofigo is supplied as a clear, colorless, isotonic, and sterile solution to be administered intravenously with pH between 6 and 8.
Each milliliter of solution contains 1,100 kBq radium-223 dichloride (30 microcurie), corresponding to 0.58 ng radium223, at the reference date. Radium is present in the solution as a free divalent cation.
Each vial contains 6 mL of solution (6,600 kBq (178 microcurie) radium-223 dichloride at the reference date). The inactive ingredients are 6.3 mg/mL sodium chloride USP (tonicity agent), 7.2 mg/mL sodium citrate USP (for pH adjustment), 0.2 mg/mL hydrochloric acid USP (for pH adjustment), and water for injection USP.
The molecular weight of radium-223 dichloride, 223RaCl2, is 293.9 g/mol.
Radium-223 has a half-life of 11.4 days. The specific activity of radium-223 is 1.9 MBq (51.4 microcurie)/ng.
The six-stage-decay of radium-223 to stable lead-207 occurs via short-lived daughters, and is accompanied predominantly by alpha emissions. There are also beta and gamma emissions with different energies and emission probabilities. The fraction of energy emitted from radium-223 and its daughters as alpha-particles is 95.3% (energy range of 5 -7.5 MeV). The fraction emitted as beta-particles is 3.6% (average energies are 0.445 MeV and 0.492 MeV), and the fraction emitted as gamma-radiation is 1.1% (energy range of 0.01 -1.27 MeV).
Last reviewed on RxList: 4/4/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Xofigo Information
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