Product InformationRegistration Status: Active
XOFIGO SOLUTION FOR INJECTION 1100KBQ/ML is approved to be sold in Singapore with effective from 2014-09-01. It is marketed by BAYER (SOUTH EAST ASIA) PTE LTD, with the registration number of SIN14478P.
This product contains Radium-223 Chloride 1000 kBq/ml in the form of INJECTION, SOLUTION (RADIOPHARMACEUTICAL). It is approved for INTRAVENOUS use.
This product is manufactured by Institute for Energy Technology (IFE) in UNITED STATES, andCardinal Health 414 in NORWAY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Radium Ra 223 Dichloride is a radiopharmaceutical containing the radioisotope radium-223 that emits short range but high linear energy alpha particles. As a cation, radium mimics calicum and binds to hydroxyapatite, which is a bone mineral found in areas of high bone turnover as seen in bone metastases. It was first approved by the FDA in May 2013 and is currently marketed under the brand name Xofigo, which was formerly called Alpharadin. Xofigo is indicated in patients who have metastatic bone cancer that is symptomatic with no visceral metastases and patients who have prostate cancer that is castration resistant. The FDA label includes a warning that Radium Ra 223 Dichloride should not be used in women who are pregnant or may become pregnant due to the high risk of fetal harm.
Used in patients who have metastatic bone cancer that is symptomatic with no visceral metastases and patients who have prostate cancer that is castration resistant.
Mechanism of Action
Radium Ra 223 Dichloride is the radioisotope radium-223 that emits short range but high linear energy alpha particles. As a cation, radium mimics calicum and binds to hydroxyapatite, which is a bone mineral found in areas of high bone turnover as seen in bone metastases. The high energy damages bone cells by introducing double-stranded DNA breaks. This leads to cell death and prevention of the spread of the bone cancer cells. As well because of the alpha particle's short range of less than 10 cell diameters, its damaging effects would less likely affect the non-cancerous cells nearby.
- Since Radium Ra 223 Dichloride is administered I.V., the bioavailability should be 100%.
- The volume of distribution was not quantified, but after 24 hours, there is only 1% radium-223 remaining in the blood. The rest of the radium-223 is distributed to bone (61% of the radioactive dose after 4 hours) and intestine (49% of the radioactive dose after 4 hours). No other organs were found to have significant uptake.
- Radium-223 does not undergo metabolism because it is a radioisotope that decays.
The clearance rate of radium-223 was not quantified.
Because of its cytotoxic actions that have a high potential to cause fetal harm, Radium Ra 223 Dichloride is contraindicated in women who are pregnant or are of child bearing age. Other side effects include several hematological lab abnormalities, peripheral edema, nausea, vomiting, and diarrhea.
RADIUM CHLORIDE RA-223 | Radium Ra-223 dichloride | Radium-223 chloride | Radium-223 dichloride | Radium Ra 223 Dichloride |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.