Copper ⁶⁴Cu chloride Other names: Copper-64 chloride

The use of Copper-64-labelled medicinal products is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded.

Before administering radiopharmaceuticals to a mother who is breast-feeding, consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding, and to the choice of the most appropriate radiopharmaceuticals, bearing in mind the secretion of activity in breast milk. If the administration is considered necessary, a breast-feeding mother should be advised to stop breast-feeding.

The duration of stopping will depend on the particular radiolabelled medicinal product. Further information concerning the use of Copper-64-labelled medicinal products in pregnancy and breast-feeding is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.

Women of childbearing potential

When an administration of radioactive medicinal products to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.

Before the use of Copper-64-labelled medicinal products, pregnancy should be excluded using an adequate/validated test.

Fertility

According to literature reports, it may be considered that both spermatogenetic and genetic damage in male test is are unlikely at the dose of 1,000 MBq.

Further information concerning the effect on fertility of the use of Copper-64-labelled medicinal products is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.

Effects on ability to drive and to use machines following treatment by Copper-64-labelled medicinal products is specified in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.

Adverse reactions following the intravenous administration of Copper-64-labelled medicinal products prepared by radiolabelling with Copper-64 chloride solution, will be dependent on the specific medicinal product being used. Such information is supplied in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.

For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical benefit.

The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended result.

The radiation dose to the patient resulting from exposure after administration may result in higher incidence of cancer and mutations. In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.