- Approval Id
- 42c41ce7f4fa7401
- Drug Name
- XOFIGO SOLUTION FOR INJECTION 1100KBQ/ML
- Product Name
- XOFIGO SOLUTION FOR INJECTION 1100KBQ/ML
- Approval Number
- SIN14478P
- Approval Date
- 2014-01-09
- Registrant
- BAYER (SOUTH EAST ASIA) PTE LTD
- Licence Holder
- BAYER (SOUTH EAST ASIA) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SOLUTION (RADIOPHARMACEUTICAL)
- Dosage
- <p><strong>4.2 Dosage and method of administration<br>
4.2.1 Method of administration</strong><br>
Xofigo is to be administered by slow intravenous injection (generally up to 1 minute).<br>
The intravenous access line or cannula must be flushed with isotonic saline before and after injection of Xofigo.<br>
For additional instructions on the use of the product see section ‘Instructions for use / handling’ – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><strong>4.2.2 Dosage regimen</strong><br>
The dose regimen of Xofigo is 55 kBq per kg body weight, given at 4-week intervals for 6 injections.<br>
Safety and efficacy beyond 6 injections with Xofigo have not been studied.<br>
For details on the calculation of the volume to be administered see section ‘Instructions for use / handling’ – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><em>Elderly patients</em><br>
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.<br>
No dose adjustment is considered necessary in elderly patients.</p>
<p><em>Patients with hepatic impairment</em><br>
Safety and efficacy of Xofigo have not been studied in patients with hepatic impairment.<br>
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.<br>
No dose adjustment is considered necessary in patients with hepatic impairment.</p>
<p><em>Patients with renal impairment</em><br>
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.<br>
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.<br>
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.<br>
No dose adjustment is considered necessary in patients with renal impairment.</p>
<p><em>Paediatric population</em><br>
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.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Indication(s)</strong><br>
Xofigo is indicated for the treatment of castration-resistant prostate cancer patients with symptomatic bone metastases and no known visceral metastatic disease.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong><br>
Xofigo is contraindicated in combination with abiraterone acetate plus prednisone/prednisolone (see section ‘Special warnings and precautions for use’ – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Pharma Manufacturer Name
- BAYER (SOUTH EAST ASIA) PTE LTD
