Other revisions to SPC include:
• New warning statement regarding increased risk of fractures and death.
• New warning that use in patients with a low level of osteoblastic bone metastases is not recommended.
• Inclusion of advice for a washout period between the last administration of abiraterone and subsequent radium-223 and vice versa.
• Addition of statement regarding treatment in mildly symptomatic patients and that the benefit of treatment should be carefully assessed to outweigh the risks considering high osteoblastic activity is likely to be required for treatment benefit.
• Addition of bone fracture (very common) and osteoporosis (uncommon) as adverse reactions.