Overview

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.

Xofigo can only be obtained with a prescription and should only be handled and given by someone who is authorised to use radioactive medicines and after evaluation of the patient by a qualified doctor.

The dose of Xofigo is calculated to provide a specific dose of radioactivity based on the patient’s body weight. The medicine is slowly injected into a vein usually for up to one minute. Injections are repeated every 4 weeks for a total of 6 injections.

For more information about using Xofigo, see the package leaflet or contact your doctor or pharmacist.

The active substance in Xofigo, radium-223, emits short-range radiation known as alpha particles. The bones in the body take up radium in the same way as calcium. The radioactive radium builds up in bone tissues where the cancer has spread, and the alpha particles destroy surrounding cancer cells and help to control the associated symptoms.

Xofigo was compared with placebo (a dummy treatment) as an addition to standard care in a main study involving 921 men with cancer of the prostate that had spread to the bones and for which suppression of male hormones using medicines or surgery did not work. Patients were given up to 6 injections at 1-month intervals and were followed up for 3 years from the first injection. Patients given Xofigo lived on average for 14.9 months, compared with 11.3 months for those given placebo. The signs and symptoms of progressive disease such as bone pain also took longer to develop in patients given Xofigo.

The most common side effects with Xofigo (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), vomiting, thrombocytopenia (low blood-platelet counts) and bone fractures. The most serious side effects were thrombocytopenia and neutropenia (low levels of neutrophils, a type of white blood cell that fights infection). For the full list of side effects of Xofigo, see the package leaflet.

Xofigo must not be used with the medicine abiraterone acetate and the corticosteroids prednisone or prednisolone. For the full list of restrictions, see the package leaflet.

The European Medicines Agency decided that Xofigo’s benefits are greater than its risks and it can be authorised for use in the EU. Xofigo has been shown to prolong life and delaying signs and symptoms of progressive disease. Regarding its safety, several measures have been put in place to minimise the risks of the medicine such as bone fractures1. The radiation emitted by Xofigo has a shorter range than the radiation of currently available radiopharmaceuticals. This may limit the damage to nearby healthy tissues.


 

1 See outcome of safety review carried out in 2018.

Xofigo can increase the risk of having fractures. The company that markets Xofigo will have to conduct studies to further characterise the safety profile of the medicine, in particular with regard to the risk of fractures and the risk of new metastases that do not affect the bone in patients treated with Xofigo.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xofigo have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Xofigo are continuously monitored. Side effects reported with Xofigo are carefully evaluated and any necessary action taken to protect patients.

Xofigo received a marketing authorisation valid throughout the EU on 13 November 2013

Xofigo : EPAR - Medicine overview

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Xofigo : EPAR - Risk-management-plan summary

Product information

Xofigo : EPAR - Product Information

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Latest procedure affecting product information: R/0049

15/09/2023

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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Xofigo : EPAR - All Authorised presentations

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Product details

Name of medicine
Xofigo
Active substance
radium (223Ra) dichloride
International non-proprietary name (INN) or common name
radium Ra223 dichloride
Therapeutic area (MeSH)
Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
V10XX03

Pharmacotherapeutic group

Therapeutic radiopharmaceuticals

Therapeutic indication

Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.

Authorisation details

EMA product number
EMEA/H/C/002653

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Marketing authorisation holder
Bayer AG

51368 Leverkusen 
Germany

Marketing authorisation issued
13/11/2013
Revision
14

Assessment history

Xofigo : EPAR - Procedural steps taken and scientific information after authorisation

Xofigo : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Xofigo-H-A-20-1459-C-002653-0028 : EPAR - Assessment report - Article 20

Xofigo-H-A-20-1459-C-002653-0028 : EPAR - Assessment report on provisional measures - Article 20

Xofigo-H-C-PSUSA-10132-201611 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Xofigo : EPAR - Public assessment report

CHMP summary of positive opinion for Xofigo

Topics

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