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Xofigo

"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"...

Xofigo

Xofigo
(radium Ra 223 dichloride)

DRUG DESCRIPTION

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 1,000 kBq radium-223 dichloride (27 microcurie), corresponding to 0.53 ng radium²23, at the reference date. Radium is present in the solution as a free divalent cation.

Each vial contains 6 mL of solution (6,000 kBq (162 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: 5/24/2013
This monograph has been modified to include the generic and brand name in many instances.

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