What is Lumark - Lutetium (177Lu) chloride used for and what is it used for?
Lumark contains the radioactive lutetium compound (177Lu) chloride and is used for the radioactive marking of other medicines. Radiolabelling is a technique that involves the marking (or labeling) of a medicine with a radioactive compound so that the radioactivity can be transported to the part of the body where it is needed, for example at the site of a tumor.
Lumark is not administered alone to patients: it is used only for radiolabelling medicines that have been specially developed for use with Lumark
How is Lumark - Lutetium (177Lu) chloride used?
Lumark should only be used by specialists with experience in radioactive marking.
Lumark is never administered alone. Radiolabelling with Lumark takes place in the laboratory. The radiolabelled medicine is subsequently administered to the patient according to the instructions in the product information of the medicine itself.
How does Lumark - Lutetium (177Lu) chloride work?
The active ingredient in Lumark, Lutetium (177Lu) chloride, is a radioactive compound that predominantly emits a type of radiation known as beta radiation, with a small amount of gamma radiation. When radiolabelled with Lumark, the medicine carries the radiation in the part of the body where it is needed, to make the cancer cells die (in case of therapeutic use) or to obtain images on a screen (in case of diagnostic use).
What benefit has Lumark - Lutetium (177Lu) chloride shown during the studies?
Since the use of Lutetium (177Lu) for the radiolabelling of medicinal products is consolidated, the company presented data from the scientific literature. Several published studies have demonstrated the usefulness of Lutetium (177Lu) in the radiolabelling of medicines for the diagnosis and treatment of neuroendocrine tumors, a group of tumors that attack hormone-secreting cells in various parts of the body, including pancreas, intestine, stomach and lungs.
The benefits of Lumark depend largely on the medicine that was used for radiolabelling.
What are the risks associated with Lumark - Lutetium (177Lu) chloride?
The side effects of Lumark depend largely on the medicine with which it is used and are described in the package leaflet of the medicine in question. In itself Lumark is radioactive, so like any other radioactive medicine, its use can involve risks related to the onset of cancer and hereditary defects. However, the amount of Lumark to use is small and therefore these risks are considered low. Your doctor needs to make sure that the expected benefits of using Lumark for patients outweigh the risks of radioactivity.
Medicines labeled with Lumark should not be used in women who are pregnant or of childbearing age. For the full list of restrictions related to the use of Lumark, see the package leaflet. For more information on the restrictions that apply to medicines radiolabelled with Lumark, see the package leaflets of the medicines in question
Why has Lumark - Lutetium (177Lu) chloride been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that the use of Lutetium (177Lu) for the radiolabelling of medicinal products is well established and well documented in the scientific literature. As with all materials used for the radiolabelling of medicines, radiation exposure associated with the use of Lumark carries risks. The Lumark product information contains information on how to minimize these risks.
The CHMP concluded that Lumark's benefits are greater than its risks and therefore recommended that it be given marketing authorization.
What measures are being taken to ensure the safe and effective use of Lumark - Lutetium (177Lu) chloride?
A risk management plan has been developed to ensure that Lumark is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lumark, including the appropriate precautions to be followed by healthcare professionals and patients.
Further information is available in the summary of the risk management plan
Further information on Lumark - Lutetium (177Lu) chloride
On 19 June 2015, the European Commission issued a marketing authorization for Lumark, valid throughout the European Union.
For the full version of the EPAR and the summary of Lumark's risk management plan, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Lumark therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 06-2015.
