Xofigo 1100 kBq/mL Solution for injection
PDF Leaflet Revision Date: 11 September 2023
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of castration-resistant prostate cancer with bone metastases.
Dosage (summary)
55 kBq/kg body weight every 4 weeks for 6 injections.
Special Populations
- Elderly
- Hepatic impairment
- Renal impairment
- Paediatric patients
Pregnancy & Breastfeeding
Not indicated for women; contraindicated in pregnancy and breastfeeding.
Key Drug Interactions
- Concomitant chemotherapy may increase bone marrow suppression.
- Not recommended with abiraterone plus prednisone/prednisolone.
Contraindications
- Hypersensitivity to radium-223 dichloride.
- Children and adolescents under 18.
Common side effects
- Diarrhoea
- Nausea
- Vomiting
- Thrombocytopenia
Counselling Points
- Use condoms and effective contraception during and up to 6 months post-treatment.
- Monitor blood counts before each dose.
- Handle with care due to radiation safety.
Serious warnings
- Bone marrow suppression.
- Potential effects on spermatogenesis.
- Risk of secondary malignant neoplasms.
Important Disclaimer
The Xofigo 1100 kBq/mL Solution for injection professional information leaflet below is the property of Bayer and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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