YTRACIS Radiopharmaceutical precursor, solution Ref.[27721] Active ingredients: Yttrium ⁹⁰Y chloride

The content of the vial of YTRACIS 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.

Radioactive medicinal products 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.

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

For information concerning special warnings and 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.

No interaction studies have been performed.

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.

YTRACIS is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3 Contraindications).

When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. Alternative techniques which do not involve ionising radiation should always be considered.

Radionuclide procedures carried out in pregnant women also involve radiation doses to the foetus. The absorbed dose to the uterus following administration of Yttrium (⁹⁰Y)-labelled medicinal products is dependent on the specific medicinal product being radiolabelled and is to be specified in the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.

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

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

No studies on the effects on the ability to drive and use machines have been performed.

Effects on ability to drive or use machines following treatment by Yttrium (⁹⁰Y)-labelled medicinal products will be specified in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.

Possible side effects following the intravenous administration of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, 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.

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

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 carrier molecules, 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.