Basic Information
Xofigo
Regulatory Information
EMEA/H/C/002653
November 13, 2013
15
August 1, 2024
Company Information
Drug Classification
Active Substances Detail
radium (223Ra) dichloride
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Overview Summary
Xofigo is a radiopharmaceutical (a medicine containing a radioactive substance) that is used to treat adults with cancer of the prostate (a gland of the male reproductive system). Xofigo is used when castration (to stop the production of male hormones) by surgery or with medicines does not work, and when the cancer has spread to the bones (bone metastases) and is causing symptoms such as pain, but has not spread to other internal organs. It should be used only for patients who have had at least two previous treatments for prostate cancer or who cannot receive other treatments. Xofigo is used on its own or in combination with a medicine known as an ‘LHRH analogue’. Xofigo contains the active substance radium-223 dichloride.