This is a summary of the European public assessment report (EPAR) for EndolucinBeta. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use EndolucinBeta.
For practical information about using EndolucinBeta, patients should read the package leaflet or contact their doctor or pharmacist.
- What is EndolucinBeta and what is it used for?
EndolucinBeta contains the radioactive compound lutetium (177Lu) chloride and is used for radiolabelling other medicines. Radiolabelling is a technique for tagging (or labelling) medicines with radioactive compounds so they can carry radioactivity to where it is needed in the body, for example the site of a tumour.
EndolucinBeta is only to be used to radiolabel medicines that have been specifically developed for use with EndolucinBeta.
- How is EndolucinBeta used?
EndolucinBeta is only used by specialists who have experience in radiolabelling.
EndolucinBeta is never given to a patient on its own. Radiolabelling with EndolucinBeta takes place in a laboratory. The radiolabelled medicine is then given to the patient according to the instructions in that medicine’s product information.
- How does EndolucinBeta work?
The active substance in EndolucinBeta, lutetium (177Lu) chloride, is a radioactive compound that mainly emits a type of radiation known as beta radiation, with small amounts of gamma radiation. When a medicine radiolabelled with EndolucinBeta is given, it carries the radiation to where it is needed in the body, either to kill cancer cells (when used for treatment) or to obtain images on a screen (when used in diagnosis).
- What benefits of EndolucinBeta have been shown in studies?
Several published studies have established the usefulness of lutetium (177Lu) in radiolabelling medicines for diagnosing and treating neuroendocrine tumours. This is a group of tumours that affect hormone-secreting cells in many parts of the body, including the pancreas, intestine, stomach and lungs. The benefits of EndolucinBeta will largely depend on the medicine that it is used to radiolabel.
- What are the risks associated with EndolucinBeta?
The side effects with EndolucinBeta depend largely on the medicine it is used with and will be described in that medicine’s package leaflet. EndolucinBeta itself is radioactive, and as with any other radioactive product, its use may carry a risk of developing cancer and defects that are passed on to children. However, the quantity of EndolucinBeta to be used is very small and therefore these risks are considered low. The doctor will ensure that the expected benefit to the patients of using EndolucinBeta outweigh the risks linked to the radioactivity.
Medicines radiolabelled with EndolucinBeta must not be used in pregnant women or women who may be pregnant. For the full list of all restrictions on the use of EndolucinBeta, see the package leaflet. Information on restrictions that apply specifically to medicines radiolabelled with EndolucinBeta can be found in the package leaflets of those medicines.
- Why is EndolucinBeta approved?
The Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that the use of lutetium (177Lu) for radiolabelling medicines was well documented in the scientific literature. As with all radiolabelling materials for medicines, there are risks linked to radiation exposure from EndolucinBeta. Information on how to minimise the risks is included in the product information for EndolucinBeta.
The CHMP concluded that the benefits of EndolucinBeta outweigh the risks and recommended that it be given marketing authorisation.
- What measures are being taken to ensure the safe and effective use of EndolucinBeta?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of EndolucinBeta have been included in the summary of product characteristics and the package leaflet.
- Other information about EndolucinBeta
The European Commission granted a marketing authorisation valid throughout the European Union for EndolucinBeta on 06 July 2016.
For more information about treatment with EndolucinBeta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 14/07/2016 .
06/07/2016 EndolucinBeta -EMEA/H/C/003999 --
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
EndolucinBeta is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride.
Changes since initial authorisation of medicine
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Initial marketing-authorisation documents
This medicine is approved for use in the European Union