What is it and how is it used?
Yttriga is a radioactive medicine used in combination with another medicine which targets specific body cells.
When the target is reached, Yttriga gives tiny radiation doses to these specific sites.
For further information regarding the treatment and possible effects caused by the radiolabelled medicinal product, please refer to the package leaflet of the medicinal product used as combination partner.
What do you have to consider before using it?
Do not use Yttriga:
- if you are allergic (hypersensitive) to Yttrium ( Y) chloride or any of the other ingredients of Yttriga.
- if you are pregnant or if there is a possibility that you may be pregnant (see below).
Take special care with Yttriga
- Yttriga is a radioactive medicine and is only used in combination with another medicinal product. It is not intended for direct use in patients.
- Because there are strict laws covering the use, handling and disposal of radiopharmaceuticals, Yttriga will always be used in a hospital or a similar setting. It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
Particular care should be taken when administering radioactive medicinal products to children and adolescents (from 2 to 16 years old).
Taking other medicines
Please tell your doctor or pharmacist, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
No interaction of Yttrium ( Y) chloride with other medicines are known as no clinical studies are available.
Pregnancy and breast-feeding
Women of childbearing potential should use effective contraception during and after treatment. Please tell your doctor if there is any possibility that you are pregnant. If you have missed a period, you should assume to be pregnant until a pregnancy test conducted is negative.
Yttriga is contraindicated in Pregnancy.
Your doctor will consider alternative techniques which do not involve ionising radiation.
Your doctor will ask you to stop breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
How is it used?
Your doctor will not administer Yttriga directly.
Dose
Your physician will decide on the amount of Yttriga, which you will receive for the treatment.
Method of administration
Yttriga is intended for radiolabelling of medicinal products to treat specific diseases, which are subsequently administered by approved route.
If Yttriga is administered inadvertently
Yttriga is administered after being combined with another medicine by your doctor under strictly controlled conditions. The risk to receive a possible overdose is small. However, should this occur, you will receive appropriate treatment from your doctor.
What are possible side effects?
Like all medicines, Yttriga can cause side effects, although not everybody gets them.
For more information, refer to the package leaflet of the particular medicinal product to be radiolabelled.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Yttriga after the expiry date and time which is stated on the label after EXP.
Store in accordance with local regulations for radioactive substances.
Any unused product or waste material should be disposed of in accordance with local requirements.
What is it?
What is it used for?
Yttriga is not used on its own but is used for radiolabelling other medicines. Radiolabelling is a technique where a substance is labelled (tagged) with a radioactive compound. Once the substance is labelled with Yttriga, it then carries the radioactivity to where it is needed in the body, for example the site of a tumour.
Yttriga is used to label medicines that have been specially developed for use with yttrium ( Y) chloride.
The medicine can only be obtained with a prescription.
How is it used?
Yttriga is only to be used by specialists who have experience in radiolabelling.
Yttriga is never given directly to a patient. Radiolabelling of a medicine takes place outside the body in a laboratory setting. The radiolabelled medicine is then given to the patient according to the instructions in that medicine’s summary of product characteristics (SmPC).
How does it work?
The active substance in Yttriga, yttrium ( Y) chloride, is a radioactive compound that emits a type of radiation known as beta radiation. The effect of Yttriga depends on the nature of the medicine that is radiolabelled with it. An example of its use is the treatment of some type of tumours, where the radiolabelled medicine carries the radioactivity to the site of a tumour to destroy the tumour cells.
How has it been studied?
As Yttriga will only be used to prepare radiolabelled medicines, no studies of Yttriga have been done in humans. The company presented information from scientific articles already published on Y. The company also presented published information on the effect of using Y to radiolabel other medicines, including one study of non-Hodgkin’s lymphoma (a cancer of the lymph tissue, part of the immune system).
What benefits has it shown during the studies?
The information supplied by the company shows the utility of Yttriga as a precursor to radiolabel medicines with 90Y.
What is the risk associated?
Yttriga is a precursor and will not be given on its own. The side effects seen with treatment involving Yttriga will therefore depend largely on the medicine being labelled and will be described in that medicine’s package leaflet. Yttriga itself is radioactive and so its use in radiolabelling may carry a risk of cancer and hereditary defects. The doctor will ensure that the risks linked to the radioactive exposure are lower than the risks from the disease itself.
Yttriga must not be given directly to any patient. Medicines radiolabelled with Yttriga should not be used in people who may be hypersensitive (allergic) to yttrium chloride or any of the other ingredients. A medicine labelled with Yttriga must not be used in women who are or may be pregnant. More information on the restrictions on the use of medicines radiolabelled with Yttriga will be found in their package leaflets.
Why has it been approved?
The CHMP decided that Yttriga’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union for Yttriga to QSA Global GmbH on 19 January 2006. The marketing authorisation is valid for an unlimited period.
This summary was last updated in 11-2010.
Name
Yttriga radiopharmaceutical precursor, solution
Composition
1 ml sterile solution contains 0.1-300 GBq Yttrium ( Y) on the reference date and time (corresponding to 0.005-15 micrograms of Yttrium [ Y]) (as Yttrium [ Y] chloride).
Each 3ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium ( Y), at reference date and time. The volume is 0.02-3 ml.
Each 10ml vial contains contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium ( Y), at reference date and time. The volume is 0.02-5 ml. The theoretical specific activity is 20 GBq/microgram of Yttrium ( Y) (see section 6.5).
Yttrium ( Y) chloride is produced by decay of its radioactive precursor Strontium ( Sr). It decay by emission of beta radiation of 2.281 MeV (99.98 %) of maximal energy to stable Zirconium ( Zr). Yttrium ( Y) has a half-life of 2.67 days (64.1 hours).
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Radiopharmaceutical precursor, solution.
Clear colourless solution, free of particulate matter.
