Lumark

lutetium, isotope of mass 177

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This is a summary of the European public assessment report (EPAR) for Lumark. 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 Lumark.

For practical information about using Lumark, patients should read the package leaflet or contact their doctor or pharmacist.

What is Lumark and what is it used for?

Lumark 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.

Lumark is not given to patients on its own; it is only to be used to radiolabel medicines that have been specifically developed for use with Lumark.

How is Lumark used?

Lumark is only used by specialists who have experience in radiolabelling.

Lumark is never given to a patient on its own. Radiolabelling with Lumark takes place in a laboratory setting. The radiolabelled medicine is then given to the patient according to the instructions in that medicine’s product information.

How does Lumark work?

The active substance in Lumark, 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 is radiolabelled with Lumark, the medicine 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 Lumark have been shown in studies?

Because the use of lutetium (177Lu) to radiolabel medicines is well established, the company presented data from the scientific literature. 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 Lumark will largely depend on the medicine that it is used to radiolabel.

What are the risks associated with Lumark?

The side effects with Lumark depend largely on the medicine it is used with and will be described in that medicine’s package leaflet. Lumark itself is radioactive, and as with any other radioactive product, its use may carry a risk of developing cancer and hereditary defects. However, the quantity of Lumark 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 Lumark outweigh the risks linked to the radioactivity.

Medicines radiolabeled with Lumark must not be used in pregnant women or women who may be pregnant. For the full list of all restrictions on the use of Lumark, see the package leaflet. Information on restrictions that apply specifically to medicines radiolabelled with Lumark will be found in the package leaflets of those medicines.

Why is Lumark approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that the use of lutetium (177Lu) for radiolabelling medicines was well established and well documented in the scientific literature. As with all radiolabelling materials for medicines, there are risks linked to radiation exposure from Lumark. Information on how to minimise the risks is included in the product information for Lumark.

The CHMP concluded that the benefits of Lumark outweigh the risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Lumark?

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 can be found in the summary of the risk management plan.

Other information about Lumark

The European Commission granted a marketing authorisation valid throughout the European Union for Lumark on 19 June 2015.

For more information about treatment with Lumark, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Lumark : EPAR - Summary for the public BG = bălgarski 2015-07-16  
Lumark : EPAR - Summary for the public ES = español 2015-07-16  
Lumark : EPAR - Summary for the public CS = čeština 2015-07-16  
Lumark : EPAR - Summary for the public DA = dansk 2015-07-16  
Lumark : EPAR - Summary for the public DE = Deutsch 2015-07-16  
Lumark : EPAR - Summary for the public ET = eesti keel 2015-07-16  
Lumark : EPAR - Summary for the public EL = elliniká 2015-07-16  
Lumark : EPAR - Summary for the public EN = English 2015-07-16  
Lumark : EPAR - Summary for the public FR = français 2015-07-16  
Lumark : EPAR - Summary for the public IT = italiano 2015-07-16  
Lumark : EPAR - Summary for the public LV = latviešu valoda 2015-07-16  
Lumark : EPAR - Summary for the public LT = lietuvių kalba 2015-07-16  
Lumark : EPAR - Summary for the public HU = magyar 2015-07-16  
Lumark : EPAR - Summary for the public MT = Malti 2015-07-16  
Lumark : EPAR - Summary for the public NL = Nederlands 2015-07-16  
Lumark : EPAR - Summary for the public PL = polski 2015-07-16  
Lumark : EPAR - Summary for the public PT = português 2015-07-16  
Lumark : EPAR - Summary for the public RO = română 2015-07-16  
Lumark : EPAR - Summary for the public SK = slovenčina 2015-07-16  
Lumark : EPAR - Summary for the public SL = slovenščina 2015-07-16  
Lumark : EPAR - Summary for the public FI = suomi 2015-07-16  
Lumark : EPAR - Summary for the public SV = svenska 2015-07-16  
Lumark : EPAR - Summary for the public HR = Hrvatski 2015-07-16  
Name Language First published Last updated
Lumark : EPAR - Risk-management-plan summary (English only) 2015-07-16  

This EPAR was last updated on 06/02/2017 .

Authorisation details

Product details

Product details for Lumark
NameLumark
Agency product numberEMEA/H/C/002749
Active substance

lutetium, isotope of mass 177

International non-proprietary name (INN) or common name

lutetium, isotope of mass 177

Therapeutic area Radionuclide Imaging
Anatomical therapeutic chemical (ATC) code V09
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Lumark
Marketing-authorisation holder

I.D.B. Radiopharmacy B.V.

Revision2
Date of issue of marketing authorisation valid throughout the European Union19/06/2015

Contact address:

I.D.B. Holland B.V.
Weverstraat 17 
5111 PV Baarle-Nassau 
The Netherlands
 

Product information

Product information

11/01/2017  Lumark -EMEA/H/C/002749 -IAIN/0004

Name Language First published Last updated
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06
Lumark : EPAR - Product Information EN = English 2015-07-16 2017-02-06

Contents

  • 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.


Name Language First published Last updated
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  
Lumark : EPAR - All Authorised presentations EN = English 2015-07-16  

Pharmacotherapeutic group

Diagnostic radiopharmaceuticals

Therapeutic indication

Lumark is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Lumark : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-09-07 2017-02-06

Initial marketing-authorisation documents

Name Language First published Last updated
Lumark : EPAR - Public assessment report EN = English 2015-07-16  
CHMP summary of positive opinion for Lumark EN = English 2015-04-24  

Authorised

This medicine is approved for use in the European Union