YTRACIS Radiopharmaceutical precursor, solution Ref.[27721] Active ingredients: Yttrium โนโฐY chloride

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: CIS bio international, Boรฎte Postale 32, F-91192 GIF-SUR-YVETTE CEDEX, FRANCE

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Not applicable
ATC code: Not applicable

Yttrium (90Y) chloride is produced by decay of its radioactive precursor Strontium (90Sr). It decays by emission of beta radiation of 2.281 MeV (99.98%) of maximal energy to stable Zirconium (90Zr). 90Y-yttrium has a half-life of 2.67 days (64.1 hours).

The pharmacodynamic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled. Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.

5.2. Pharmacokinetic properties

The pharmacokinetic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.

In the rat, following intravenous administration, Yttrium (90Y) chloride is rapidly cleared from the blood. At 1 and 24 hours, blood radioactivity decreases from 11% to 0.14% of the administered activity. The two main organs where Yttrium (90Y) chloride distributes are the liver and bones. In the liver, 18% of the injected activity is taken up 5 min after injection. Liver uptake decreases then to 8.4% 24 hours after injection. In bone, percentage of injected activity increases from 3.1% at 5 min to 18% at 6 hours and then decreases with time. Faecal and urinary elimination is slow: about 13% of the administered activity is eliminated in 15 days.

5.3. Preclinical safety data

The toxicological properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.

There are no data available on the toxicity of Yttrium (90Y) chloride nor on its effects on reproduction in animals or its mutagenic or carcinogenic potential.

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