Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: A.C.O.M. - ADVANCED CENTER ONCOLOGY MACERATA S.R.L., Località Cavallino 39 A/B, 62010 Montecosaro (MC), Italy Tel.: 0039.0733.229739, Fax: 0039.0733.560352, E-mail: amministrazione@acompet.it
Pharmacotherapeutic group: various diagnostic radiopharmaceuticals
ATC code: Not yet assigned
The pharmacodynamic properties of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina, 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.
The European Medicines Agency has waived the obligation to submit the results of the studies with Cuprymina in all subsets of the paediatric population on grounds of lack of significant therapeutic benefit over existing treatments. This waiver does however not extend to any diagnostic or therapeutic uses of the medicinal product when linked to a carrier molecule.
The pharmacokinetic properties of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Pharmacokinetics of Cuprymina was investigated in mice. Following intravenous administration, at the beginning most organs contained an amount of radioactivity which represented their content of Copper-64-laden blood. Liver, kidney and the intestinal tract reached their maximal content of Copper-64 within the first few hours, and then radioactivity steadily diminished. Part of the decrease can be attributed to excretion of Copper-64 into the bile, urine and faeces.
Blood radioactivity decreased from 60.3% to 3.4% after 1 hour, and then it decreased of 1% after 6 hours, and increased to 5.6% and 4.9% after 12-24 hours.
Copper chloride (64CuCl2) is distributed mainly in the liver and kidney and the pattern of radioactivity in the blood parallels the pattern of radioactivity in the liver. Almost the entire 64CuCl2 rapidly leaves the blood and enters the liver and kidney.
Maximum liver uptake was 4 hours after injection with 57.7%. Then copper re-emerges in plasma and is distributed to other organs.
When the precursor is bound to a carrier molecule the content of radioactive free copper is supposed to be less than the stated amounts depending on the carrier used. Relevant data is included in the Summary of Product Characteristics of the labelled medicinal products.
The toxicological properties of Copper-64-labelled medicinal products prepared by radiolabelling with
Cuprymina prior to administration will be dependent on the nature of the medicinal product to be radiolabelled.
No animal toxicity studies were conducted with Cuprymina.
Toxicity of copper compounds has been extensively investigated both in human and in animals. Liver, gastrointestinal tract and kidney are the target organs for copper toxicity after single and repeated doses administration. Many international bodies assessed copper genotoxicity and carcinogenicity concluding that there is no conclusive evidence that copper may be mutagenic or carcinogenic The Scientific Committee on Food of the European Commission (2003) recommend a Dietary Allowances of 0.9 mg copper/day in adult males and females and established a Tolerable Upper Uptake level of 5 mg/day, allowing a huge safety margin in comparison to copper amount administered by Cuprymina.
Non-clinical data reveal no special hazard for humans based on available published data.
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