What is Yttriga
?Yttriga is a radioactive liquid containing the active ingredient yttrium chloride (90Y). Yttrium 90Y chloride is the radioactive form of the yttrium chemical element.
What is Yttriga used for?
Yttriga is used for the radiolabelling of medicines. Radiolabelling is a technique that involves the marking (labeling) of a substance with a radioactive compound. In the case of Yttriga, the product is used to label drugs specially developed for the use of the active ingredient yttrium chloride (90Y). These drugs act as carriers that carry radioactivity to the point where it is needed. These can be substances such as antibodies, designed to recognize certain cells in the body, including cancer cells.
The effects of the radiolabelled medicinal product with Yttriga are detailed in the package insert for the radiolabelled medicine with Yttriga.
The medicine can only be obtained with a prescription.
How is Yttriga used?
Yttriga should be handled and administered only by specialists experienced in the safe use of radioactive material.
Yttriga is never administered alone, but must be mixed outside the body, usually in the laboratory, with the medicine that requires radiolabelling. Yttrium90 contained in Yttriga is therefore bound to the medicinal product and the resulting mixture is administered following the directions in the package insert of the resulting medicinal product. The amount of Yttriga needed for radiolabelling and the amount of radiolabelled medicine that is subsequently administered depend on the radiolabelled medicine and the illness to be treated.
How does Yttriga work?
The active ingredient of Yttriga, yttrium chloride (90Y), is a radioactive compound that emits beta radiation. The effect of Yttriga depends on the nature of the medicine radiolabelled with Yttriga. An example of its use is in the case of the treatment of some types of tumors, in which the radiolabelled medicine transports radioactivity to the areas where the tumor is located. Once in place, the radioactivity of Yttriga helps eliminate the tumor.
What studies have been carried out on Yttriga?
Since Yttriga is a "precursor" and is not administered alone, no human studies have been conducted. The company has presented information taken from scientific articles already published in the 90Y area. The company also presented published studies that demonstrate the usefulness of yttrium90Y for radiolabelling other medicines. An example of this is a study on non-Hodgkin's lymphoma (cancer of the tissues of the immune system).
What benefit has Yttriga shown during the studies?
The information provided by the company demonstrates the usefulness of Yttriga as a precursor to radiolabelled 90Y medicines.
What is the risk associated with Yttriga?
Since Yttriga is a precursor and is not administered alone, it does not produce any side effects. Patients may eventually experience side effects after intravenous administration of a medicine prepared by marking with Yttriga. These effects will depend on the specific medicine used and will be described in the package insert of the medicine marked with Yttriga. Yttriga produces radiation and can induce a risk of cancer and hereditary defects. The doctor or specialist who prescribes the medicine must make sure that the risks of the radiation are less than those of the disease itself.
Yttriga should not be given directly to patients. Medicinal products marked with Yttriga must not be used in people who are hypersensitive (allergic) to yttrium chloride or any of the other ingredients. Medicinal products marked with Yttriga should not be used in pregnant or suspected pregnancy patients. For more information on the restrictions on Yttriga labeled medicines, read the package leaflet of the radiolabelled medicinal product with Yttriga.
Why has Yttriga been approved?
The Committee for Medicinal Products for Human Use (CHMP) has decided that the benefits of Yttriga outweigh the risks for radiolabelling of carrier molecules specifically developed and authorized for radiolabelling with this radionuclide and has therefore recommended the issuance of the authorization to placing on the market.
More information on Yttriga
On 19 January 2006, the European Commission granted a marketing authorization valid for Yttriga, valid throughout the European Union, to QSA Global GmbH.
For the full version of the evaluation (EPAR) of Yttriga, click here .
Last update of this summary: 1-2007
