XOFIGO SOLUTION FOR INJECTION 1100kBq/ML

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Therapeutic

Prescription Only

INJECTION, SOLUTION (RADIOPHARMACEUTICAL)

**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’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. **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’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. _Elderly patients_ 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. _Patients with 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. _Patients with 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 on patients with moderate (CLCR: 30 to 50 mL/min) and severe (CLCR: <30ml/min) renal impairment. No data are available on patients with 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.