YTRACIS Radiopharmaceutical precursor, solution Ref.[27721] Active ingredients: Yttrium ⁹⁰Y chloride

YTRACIS is only to be used by specialists with the appropriate experience.

The quantity of YTRACIS required for radiolabelling and the quantity of Yttrium (⁹⁰Y)-labelled medicinal product that is subsequently administered will depend on the medicinal product radiolabelled and its intended use. Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.

YTRACIS is intended for in vitro radiolabelling of medicinal products, which are subsequently administered by approved route.

Dosimetry

The radiation dose received by the various organs following administration of a Yttrium (⁹⁰Y)- labelled medicinal product will be dependent on the specific pharmaceutical being radiolabelled. Information on radiation dosimetry of each different medicinal product following administration of the radiolabelled preparation will be available in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.

The dosimetry table below is presented in order to evaluate the contribution of non-conjugated Yttrium (⁹⁰Y) to the radiation dose following the administration of Yttrium (⁹⁰Y)-labelled medicinal product or resulting from an accidental intravenous injection of YTRACIS.

The dosimetry estimates were based on a rat biodistribution study and the calculations were effected in accordance with MIRD/ICRP 60 recommendations. Timepoints for measurements were 5 minutes, 1 hour, 6 hours, 1 day, 4 days and 15 days.

Organ doses (mGy/MBq injected) and effective dose (Sv/GBq injected):

For this product, the effective dose resulting from an intravenously injected activity of 1 GBq is 700 mSv for a 57-kg female adult and 650 mSv for a 70-kg male adult.

The presence of free Yttrium (⁹⁰Y) chloride in the body after an inadvertent administration of Ytracis will lead to increase bone marrow toxicity and haematopoetic stem cell damage. Therefore, in case of an inadvertent administration of Ytracis, the radiotoxicity for the patient must be reduced by immediate (i.e. within 1 hour) administration of preparations containing chelators like Ca-DTPA or Ca-EDTA in order to increase the elimination of the radionuclide from the body.

The following preparations must be available in medical institutions, which use Ytracis for radiolabelling of carrier molecules for therapeutic purposes:

Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or

Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)

These chelating agents suppress yttrium radiotoxicity by an exchange between the calcium ion and the yttrium due to their capacity of forming water soluble complexes with the chelating ligands (DTPA, EDTA). These complexes are rapidly eliminated by the kidneys.

1 g of the chelating agents should be administered by slow intravenous injection over 3-4 minutes or by infusion (1 g in 100-250 ml of dextrose, or normal saline).

The chelating efficacy is greatest immediately or within one hour of exposure when the radionuclide is circulating in or available to tissue fluids and plasma. However, a post-exposure interval >1 hour does not preclude the administration and effective action of chelator with reduced efficiency. Intravenous administration should not be protracted over more than 2 hours.

In any case the blood parameters of the patient have to be monitored and the appropriate actions immediately taken if there is evidence of damage to the blood marrow.

The toxicity of the free Yttrium (⁹⁰Y) due to in-vivo release from the labelled biomolecule in the body during therapy could be reduced by post-administration of chelating agents.

7 days from the date/hour of manufacture.

Store in the original package.

Storage should be in accordance with local regulations for radioactive substances.

Colourless Type I glass 2-ml vial, closed with Teflon-coated bromobutyl rubber stopper and aluminium overseal.

1 vial contains 0.5 to 2 ml (corresponding to 0.925 to 3.700 GBq calibrated three or four days after the manufacturing date) depending on the ordered radioactivity.

The vial is supplied in a lead pot of appropriate thickness.

The administration of radioactive medicinal products creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc. Radiation protection precautions in accordance with national regulations must therefore be taken.

Any unused product or waste material should be disposed of in accordance with local requirements.

See section 12, for detailed instructions of product preparation.