Xofigo - radium-223 dichloride

What is Xofigo - radium-223 dichloride and what is it used for?

Xofigo is a radiopharmaceutical (a medicine containing a radioactive substance) that contains the active substance radio-223 dichloride. Xofigo is used to treat adult men with cancer of the prostate (a gland in the male reproductive system). Xofigo is used when medical or surgical castration (interruption of the production of male hormones in the body by drug therapy or surgery) has not worked and when the cancer has spread to the bone, where it causes symptoms (including pain), but not to other internal organs.

How is Xofigo used - radium-223 dichloride?

Xofigo can only be obtained with a prescription and should only be used and administered by personnel authorized to handle radioactive medicines and after the patient has been evaluated by a qualified doctor. Xofigo is available as a solution for injection. The dose of Xofigo is calculated based on the patient's body weight in order to provide a specific dose of radioactivity (50 kBq per kg body weight; kilobecquerel is the unit of measurement of the activity of a radionuclide). The medicine is given by slow intravenous injection, usually up to 1 minute. The injections are repeated every 4 weeks for a total of 6 injections. For more information, see the package leaflet.

How does Xofigo - radium-223 dichloride work?

The active substance in Xofigo, radium-223, emits short-range radiation, called alpha particles. In the body, radium is handled like calcium that is normally found in bones. It accumulates in the bone tissues where cancer has spread and where alpha particles destroy surrounding cancer cells, helping to control cancer symptoms.

What benefit has Xofigo - radium-223 dichloride shown during the studies?

Xofigo was compared with placebo (a substance that has no effect on the body) as an add-on treatment to standard therapy in a main study involving 921 men with prostate cancer that had spread to the bone and in whom the suppression of male hormones by drug therapy or surgery had failed. Patients received up to 6 injections, at 1 month intervals of each other, and were monitored for up to 3 years after the first injection. The main measure of effectiveness was how long the patients survived. Median survival in patients treated with Xofigo was 14.9 months compared with 11.3 months in the placebo group. longer before the typical signs and symptoms of progressive disease reappear, including fractures and bone pain.

What is the risk associated with Xofigo - radium-223 dichloride?

The most common side effects with Xofigo (which may affect more than 1 in 10 people) are diarrhea, nausea, vomiting and thrombocytopenia (decrease in the number of platelets in the blood). The most serious side effects were thrombocytopenia and neutropenia (decreased number of neutrophils, a type of white blood cell responsible for fighting infections). For the full list of side effects reported with Xofigo, see the package leaflet.

Why has Xofigo - radium-223 dichloride been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xofigo's benefits are greater than its risks and recommended that it be approved for use in the EU. Xofigo had demonstrated a clinically significant benefit in terms of prolongation. patient life and delay in the onset of signs and symptoms of progressive disease. The major short-term side effects of the medicine are reversible and were considered manageable. The radiation emitted by Xofigo has a shorter range of action than radiopharmaceuticals currently commercially available. This can help limit the damage created to adjacent healthy tissues.

What measures are being taken to ensure the safe and effective use of Xofigo - radium-223 dichloride?

A risk management plan has been developed to ensure that Xofigo is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Xofigo, including the appropriate precautions to be followed by healthcare professionals and patients.

More information about Xofigo - radium-223 dichloride

On November 13, 2013, the European Commission granted a "Marketing Authorization" for Xofigo, valid throughout the European Union. For more information on Xofigo therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 10-2013.

The information on Xofigo - radio-223 dichloride published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.

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