YTTRIGA Radiopharmaceutical precursor, solution Ref.[11010] Active ingredients: Yttrium ⁹⁰Y chloride

The contents of the vial of Yttriga is not to be administered directly to the patient but must be used for the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates.

Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings and receipt, storage, use, transfer and disposal are subject to the regulations and appropriate licences of the competent authorities.

Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.

For information concerning special warnings and special precautions for use of Yttrium (⁹⁰Y)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.

Particular care should be taken when administering radioactive medicinal products to children and adolescents (from 2 to 16 years old).

No interaction studies of Yttrium (⁹⁰Y) chloride with other medicinal products have been performed, because Yttriga is a precursor solution for radiolabelling medicinal products.

For information concerning interactions associated with the use of Yttrium (⁹⁰Y)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.

Women of childbearing potential

Women of childbearing potential have to use effective contraception during and after treatment.

Pregnancy

Yttrium (⁹⁰Y)-labelled medicinal products are contraindicated in established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3).

Breast-feeding

Before administering a radioactive medicinal product to a mother who is breast-feeding, consideration should be given to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding. If the administration cannot be delayed, a lactating mother should be advised to stop breast-feeding.

Further information concerning the use of a Yttrium (⁹⁰Y)-labelled medicinal products in pregnancy and breast-feeding is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.

Fertility

Further information concerning the use of a Yttrium (⁹⁰Y)-labelled medicinal concerning fertility 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 Yttrium (⁹⁰Y)-labelled medicinal products will be specified in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.

Possible adverse reactions following the intravenous administration of a Yttrium (⁹⁰Y)-labelled medicinal product prepared by radiolabelling with Yttriga, will be dependent on the specific medicinal product being used. Such information will be 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 therapeutic result.

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

The radiation dose resulting from therapeutic exposure 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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Radiolabelling of medicinal products, such as monoclonal antibodies, peptides or other substrates, with Yttrium (⁹⁰Y) chloride is very sensitive to the presence of trace metal impurities.

It is important that all glassware, syringe needles etc, used for the preparation of the radiolabelled medicinal product are thoroughly cleaned to ensure freedom from such trace metal impurities. Only syringe needles (for example, non-metallic) with proven resistance to dilute acid should be used to minimise trace metal impurity levels.