Lumeblue (previously Methylthioninium chloride Cosmo)
Authorised
This medicine is authorised for use in the European Union
methylthioninium chloride
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Methylthioninium chloride Cosmo is used in adults as a dye to help doctors see the lining of the colon (large bowel) more clearly and improve detection of lesions (abnormalities) during colonoscopy, a procedure to examine the colon through a tube with a camera.
Methylthioninium chloride Cosmo contains the active substance methylthioninium chloride.
Methylthioninium chloride Cosmo is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but the authorised use, strength, pharmaceutical form and route of administration are different. The reference medicine for Methylthioninium chloride Cosmo is Metilénkék Pharmamagist, a medicine authorised in Hungary.
Methylthioninium chloride Cosmo can only be obtained with a prescription.
It is available as 25 mg tablets. The recommended total dose is 200 mg methylthioninium chloride (8 tablets) by mouth taken the day before the colonoscopy together with a bowel cleansing preparation (a medicine that clears all solid matter from the colon) of 4 litres in total. The first 3 tablets should be taken after drinking at least 1 litre of the bowel cleansing preparation; the next 3 tablets should be taken 1 hour after the first dose and the last 2 tablets should be taken 1 hour after the second dose.
For more information about using Methylthioninium chloride Cosmo, see the package leaflet or contact your doctor or pharmacist.
The active substance in Methylthioninium chloride Cosmo, methylthioninium chloride (also called methylene blue), has been widely used for medical purposes. Methylthioninium chloride enters cells such as those in the small intestine and colon and temporarily stains the lining of these organs. Because the amount of methylthioninium chloride taken up by different types of cells varies, the medicine helps doctors identify any abnormalities in the makeup of the lining.
The tablets have a special coating which allows the medicine to reach the colon before methylthioninium chloride is slowly released to stain the lining evenly.
Methylthioninium chloride Cosmo improved detection of adenoma (a type of tumour linked to increased risk of cancer) or carcinoma (a type of cancer) during colonoscopy.
At least one adenoma or carcinoma was detected in 56% of patients (273 out of 485) who received Methylthioninium chloride Cosmo compared with 48% of patients (229 out of 479) who did not receive it. The presence of adenoma and carcinoma was later confirmed by examining tissue after removing it from the colon. Using Methylthioninium chloride Cosmo did not lead to a higher number of ‘false positive’ results.
The most common side effects with Methylthioninium chloride Cosmo (which may affect more than 1 in 10 people) are discoloration of the urine and faeces, which disappears after a few days. Short-lived nausea and vomiting are also common (they can affect up to 1 in 10 people).
Methylthioninium chloride Cosmo must not be used in patients who are hypersensitive (allergic) to peanuts, soya or any ingredients in the medicine. It must also not be used in patients in whom the enzyme glucose-6-phosphate dehydrogenase (G6PD) is not working (G6PD deficiency). It must not be taken during pregnancy and when breastfeeding.
Methylthioninium chloride Cosmo improves detection of adenoma and carcinoma in the colon during colonoscopy, which may lead to a reduction in the risk of colorectal cancer if removed. The safety profile of Methylthioninium chloride Cosmo is well known from other medicines and products containing the same active substance; the side effects are mainly mild or moderate and of short duration. The European Medicines Agency therefore decided that Methylthioninium chloride Cosmo’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Methylthioninium chloride Cosmo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Methylthioninium chloride Cosmo are continuously monitored. Side effects reported with Methylthioninium chloride Cosmo are carefully evaluated and any necessary action taken to protect patients.
Methylthioninium chloride Cosmo received a marketing authorisation valid throughout the EU on 19 August 2020.
Product information
Latest procedure affecting product information:
T/0006
14/11/2024
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
- Lumeblue (previously Methylthioninium chloride Cosmo)
- Active substance
- methylthioninium chloride
- International non-proprietary name (INN) or common name
- methylthioninium chloride
- Therapeutic area (MeSH)
- Colorectal Neoplasms
- Colonoscopy
- Anatomical therapeutic chemical (ATC) code
- V04CX
Pharmacotherapeutic group
Other diagnostic agentsTherapeutic indication
Lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.
News on Lumeblue (previously Methylthioninium chloride Cosmo)
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