XOFIGO SOLUTION FOR INJECTION 1100kBqML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

RADIUM-223 CHLORIDE

Available from:

BAYER (SOUTH EAST ASIA) PTE LTD

Dosage:

1000 kBq/ml

Pharmaceutical form:

INJECTION, SOLUTION (RADIOPHARMACEUTICAL)

Composition:

RADIUM-223 CHLORIDE 1100 kBq/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Agilera Pharma AS

Authorization status:

ACTIVE

Authorization date:

2014-01-09

Patient Information leaflet

Xofigo_CCDSv2.1_15Jan2014 

1. NAME OF THE MEDICINAL PRODUCT 
Xofigo solution for injection. 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each ml of solution contains 1000 kBq radium Ra 223 dichloride
(radium-223 dichloride), corresponding 
to 0.53 ng radium-223, at the reference
date. Radium is present in the solution as a free ion. 

Each vial contains 6 ml of solution (6.0 MBq radium-223
dichloride at the reference date). 

Radium-223 is an alpha particle-emitter with a half-life
of 11.4 days. The specific activity of radium-223 is 
1.9 MBq/ng. 

The six-stage-decay of radium-223 to lead-207 occurs via
short-lived daughters, and is accompanied by a 
number of alpha, 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 
5.0 -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). 

3. PHARMACEUTICAL FORM 
Solution for injection. 

4. CLINICAL PARTICULARS 
4.1 INDICATION(S) 
Xofigo is indicated for the treatment of castration-resistant
prostate cancer patients with symptomatic 
bone metastases and no known visceral metastatic disease. 

4.2 DOSAGE AND METHOD OF ADMINISTRATION 
4.2.1 METHOD OF ADMINISTRATION 
Xofigo is to be administered by slow
intravenous injection (generally up to 1 minute). 
The intravenous access line or cannula must be
flushed with isotonic saline before and after injection of 
Xofigo. 
For additional instructions on the use of the product see section
‘
Instructions for use/handling
’. 

4.2.2 DOSAGE REGIMEN 
The dose regimen of Xofigo is 50 kBq per kg
body weight, given at 4 week intervals for 6 

Summary of Product characteristics

Xofigo_CCDSv6_ 1Nov2019
1. NAME OF THE MEDICINAL PRODUCT
Xofigo solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 1100 kBq radium Ra 223 dichloride
(radium-223 dichloride), corresponding
to 0.58 ng radium-223, at the reference date. Radium is present in the
solution as a free ion.
Each vial contains 6 ml of solution (6.6 MBq radium-223 dichloride at
the reference date).
Radium-223 is an alpha particle-emitter with a half-life of 11.4 days.
The specific activity of radium-223 is
1.9 MBq/ng.
The six-stage-decay of radium-223 to lead-207 occurs via short-lived
daughters, and is accompanied by a
number of alpha, 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
5.0 -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).
3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICULARS
4.1 INDICATION(S)
Xofigo is indicated for the treatment of castration-resistant prostate
cancer patients with symptomatic
bone metastases and no known visceral metastatic disease.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
4.2.1 METHOD OF ADMINISTRATION
Xofigo is to be administered by slow intravenous injection (generally
up to 1 minute).
The intravenous access line or cannula must be flushed with isotonic
saline before and after injection of
Xofigo.
For additional instructions on the use of the product see section
‘Instructions for use/handling’.
4.2.2 DOSAGE REGIMEN
The dose regimen of Xofigo is 55 kBq per kg body weight, given at 4
week intervals for 6 injections.
Safety and efficacy beyond 6 injections with Xofigo have not been
studied.
For details on the calculation of the volume to be administered see
section ‘Instructions for use/ handling’.
_Elderly patients _
No overall differences in safety or efficacy