Source: Medicines Authority (MT) Revision Year: 2019 Publisher: CIS bio international, RN 306-Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex
Pharmacotherapeutic group: Other radiopharmaceutical products for diagnostic use
ATC code: V09IX05
At the chemical concentrations and activities recommended for diagnostic examinations, fluorodopa (18F) does not appear to have any pharmacodynamic activity.
Studies in healthy subjects after administration of fluorodopa (18F) showed an ubiquitous distribution of activity in all body tissues.
Fluorodopa (18F) is an analogue of an aromatic amino acid rapidly accumulated by target tissues, especially in the striatum of the human brain, and converted into dopamine, neurotransmitter of the catecholamines family.
Fluorodopa (18F) is eliminated by the kidney, 50% is removed after 0.7 hours, and 50% after 12 hours.
Fluorodopa (18F) is eliminated by a bi-exponential kinetics with a biological half-life of 12 hours (67-94%) and a physical half-life of 1.7 to 3.9 hours (6-33%). These two half-lives seem to depend on age.
Toxicological studies with rats have demonstrated that with a single IV injection at 5 mL/kg of a preparation of inactive fluorodopa containing more than 100 times the amount of active substance and impurities contained in Dopacis, no deaths were observed. The same preparation did not present any mutagenic activity in the Ames test.
Repeated toxicity studies, long-term carcinogenicity studies and reproductive function studies have not been carried out.
This agent is not intended for regular or continuous administration.
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