What is Ytracis?
Ytracis is a solution containing the active substance yttrium (90Y) chloride. 90Y, yttrium -90, is a radioactive form of the yttrium chemical element.
What is Ytracis used for?
Ytracis is used for radioactive marking purposes. Radiolabelling is a technique by which a substance is marked (marked) with a radioactive compound. In the case of Ytracis, the product is used to mark medicines that have been specifically developed to be used with the active yttrium (90Y) chloride principle. These medicines act as carriers to bring radioactivity where needed. They can be substances, such as antibodies that have been designed to recognize a particular type of cell in the body, including cancer cells.
The effects of the medicine radiolabelled with Ytracis will be fully explained in the package leaflet.
The medicine can only be obtained with a prescription.
How is Ytracis used?
Ytracis should only be handled by appropriately trained personnel for the safe handling of radioactive material.
Ytracis should never be given directly to the patient. It must be mixed outside the human body, usually in a laboratory, with the drug to be radiolabelled. The Yttrium -90 content in Ytracis is then combined with the carrier medicine and the resulting mixture is administered in accordance with the instructions on the package insert of the carrier drug. The amount of Ytracis needed for radiolabelling and the amount of radiolabelled medicine administered subsequently depend on the radiolabelled medicine and the disease being treated.
How does Ytracis work?
The active ingredient present in Ytracis, the yttrium (90Y) chloride, is a radioactive compound. Emits beta radiation. The effect of Ytracis depends on the nature of the carrier drug that is radiolabelled with Ytracis. An example of use is the treatment in some types of tumors, where the radiolabelled drug transports radioactivity to the tumor site. Once in situ, the radioactivity of Ytracis helps to destroy the tumor.
What studies have been carried out on Ytracis?
Since Ytracis is a "precursor" and is not administered directly, no studies have been performed in humans. The company presented information taken from scientific articles published in 90Y. The company also presented published information supporting the use of 90Y for the radiolabelling of other drugs.
What benefit has Ytracis shown during the studies?
The information provided by the company supports the use of Ytracis as a precursor for radiolabelling drugs with 90Y.
What is the risk associated with Ytracis?
Since Ytracis is a "precursor" and is not administered alone, it has no side effects. Patients may experience side effects following the injection of a radiolabelled drug with Ytracis. These side effects depend on the drug used and will be described in the leaflet of the drug marked with Ytracis. Ytracis is radioactive and its use may involve cancer and hereditary defects. The doctor who prescribes Ytracis must ensure that the risks associated with radioactive exposure are lower than the risks of the disease itself.
Ytracis should not be given directly to patients. Radiolabelled drugs with Ytracis should not be administered in case of hypersensitivity (allergy) to yttrium chloride or to any of its excipients. A drug labeled with Ytracis should not be used in cases of confirmed or suspected pregnancy. More information on the contraindications of radiolabelled drugs with Ytracis will be provided in the package leaflet of the drug that is radiolabelled with Ytracis.
Why has Ytracis been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Ytracis outweigh the risks for the radiolabelling of molecules that have been specifically developed and authorized for radiolabelling with this radionuclide. The committee recommended the granting of a marketing authorization in favor of Ytracis.
More information on Ytracis
On 24 March 2003, the European Commission issued a marketing authorization for Ytracis, valid throughout the European Union, to CIS bio international. The marketing authorization was renewed on 24 March 2008.
The full EPAR for Ytracis can be found here.
Last update of this summary: 02-2008.
