Lutetium (177Lu) chloride Billev (previously Illuzyce)
Authorised
This medicine is authorised for use in the European Union
lutetium (177Lu) chloride
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Lutetium (177Lu) chloride Billev is a solution containing a radioactive form of lutetium (177lu) that is used for radiolabelling other medicines. Radiolabelling is a technique where a substance is labelled with a radioactive compound. Once the substance is radiolabelled with Lutetium (177Lu) chloride Billev, it then carries the radioactivity to where it is needed in the body (for example, the site of a tumour).
Lutetium (177Lu) chloride Billev is used to radiolabel medicines that have been specifically developed for use with lutetium (177lu) chloride.
Lutetium (177Lu) chloride Billev contains the active substance lutetium (177lu) chloride.
Lutetium (177Lu) chloride Billev is only to be used by specialists who have experience in radiolabelling. Lutetium (177Lu) chloride Billev is never given directly to a patient. Radiolabelling of a medicine takes place 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).
The active substance in Lutetium (177Lu) chloride Billev, lutetium (177lu) chloride, is a radioactive compound that emits mainly a type of radiation known as ‘beta-minus’, for treatment, and a small amount of gamma radiation, for imaging. When a medicine is radiolabelled with Lutetium (177Lu) chloride Billev, the medicine will carry the radiation to the particular site or type of cell in the body that is targeted by the medicine
The company presented information from published clinical studies on the potential uses of Lutetium (177Lu) chloride Billev. Some of the data presented showed the usefulness of 177Lu in radiolabelling medicines for treating neuroendocrine tumors and prostate cancer, used together with imaging techniques to detect the site and spread of tumours.
The side effects with Lutetium (177Lu) chloride Billev depend largely on the medicine it has been used to radiolabel and will be described in that medicine’s package leaflet. Lutetium (177Lu) chloride Billev itself is radioactive and so its use in radiolabelling may carry a risk of developing 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.
The most common side effects (which may affect more than 1 in 10 people) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), lymphopenia (low levels of lymphocytes, a particular type of white blood cell), nausea (feeling sick), vomiting and hair loss.
Lutetium (177Lu) chloride Billev must not be given directly to any patient. It must not be used in women who are known to be or may be pregnant, and when pregnancy has not been ruled out. For the full list of restrictions of Lutetium (177Lu) chloride Billev, see the package leaflet.
Information on the restrictions on the use of medicines radiolabelled with Lutetium (177Lu) chloride Billev can be found in the respective package leaflets.
The European Medicines Agency decided that Lutetium (177Lu) chloride Billev’s benefits for radiolabelling medicines are greater than its risks and it can be authorised for use in the EU. Given the well-known risks linked to radiation exposure, the Agency concluded Lutetium (177Lu) chloride Billev is only to be used if justified by the likely medical benefit.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lutetium (177Lu) chloride Billev have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Lutetium (177Lu) chloride Billev are continuously monitored. Suspected side effects reported with Lutetium (177Lu) chloride Billev are carefully evaluated and any necessary action taken to protect patients.
Lutetium (177Lu) chloride Billev received a marketing authorisation valid throughout the EU on 15 September 2022.
This overview was last updated in 12-2022.
Product information
Latest procedure affecting product information:
II/0005/G
07/11/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Lutetium (177Lu) chloride Billev (previously Illuzyce)
- Active substance
- lutetium (177Lu) chloride
- International non-proprietary name (INN) or common name
- lutetium (177Lu) chloride
- Therapeutic area (MeSH)
- Radionuclide Imaging
- Anatomical therapeutic chemical (ATC) code
- V10X
Pharmacotherapeutic group
Therapeutic radiopharmaceuticalsTherapeutic indication
Lutetium (177Lu) chloride Billev 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.
News on Lutetium (177Lu) chloride Billev (previously Illuzyce)
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