Posology : מינונים

4.2   Posology and method of administration

Xofigo should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings (see section 6.6) and after evaluation of the patient by a qualified physician.

Posology

The dose regimen of Xofigo is an activity of 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 10.
Elderly
No overall differences in safety or efficacy were observed between elderly (aged ≥ 65 years) and younger patients (aged < 65 years) in the phase III study.
No dose adjustment is considered necessary in elderly patients.

Hepatic impairment
Safety and efficacy of Xofigo have not been studied in patients with hepatic impairment.
Since radium-223 is neither metabolised by the liver nor eliminated via the bile, hepatic impairment is not expected to affect the pharmacokinetics of radium-223 dichloride.
No dose adjustment is considered necessary in patients with hepatic impairment.

Renal impairment
In the phase III clinical study, no relevant differences in safety or efficacy were observed between patients with mild renal impairment (creatinine clearance [CLCR]: 50 to 80 mL/min) and normal renal function.
Limited data are available for patients with moderate (CLCR: 30 to 50 mL/min) renal impairment. No data are available for patients with severe (CLCR < 30 mL/min) renal impairment or end-stage renal disease.
However, since excretion in urine is minimal and the major route of elimination is via the faeces, renal impairment is not expected to affect the pharmacokinetics of radium-223 dichloride.
No dose adjustment is considered necessary in patients with renal impairment.

Paediatric population
The safety and efficacy of Xofigo in children and adolescents below 18 years of age have not been studied.
There is no relevant use of this medicinal product in the paediatric population in the indication of prostate cancer.

Method of administration

Xofigo is for intravenous use. It must be administered by slow injection (generally up to 1 minute).
The intravenous access line or cannula must be flushed with isotonic sodium chloride 9 mg/mL (0.9%) solution for injection before and after injection of Xofigo.

For additional instructions on the use of the medicinal product, see sections 6.6 and 10.