Methylthioninium chloride Proveblue 5 mg/ml solution forinjection

ATC Code
V03AB17
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Provepharm S.A.S.

Substance Narcotic Psychotropic
Methylthioninium chloride No No
Pharmacological group All other therapeutic products

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All to know

Author

Provepharm S.A.S.

What is it?

Methylthioninium chloride Proveblue is a solution for injection that contains the active substance methylthioninium chloride (5 mg/ml).

Methylthioninium chloride Proveblue is a ?hybrid generic medicine?. This means that it is similar to a reference medicine, containing the same active substance but in a different concentration. The reference medicine for Methylthioninium chloride Proveblue is Methylthioninium Chloride Injection USP 1% w/v.

What is it used for?

Methylthioninium chloride Proveblue is used in adults and children of all ages as an antidote to treat symptoms of methaemoglobinaemia caused by exposure to medicines or chemicals.

Methaemoglobinaemia is a condition where there is too much of an abnormal form of haemoglobin in the blood that is not able to transport oxygen effectively. Substances that may cause methaemoglobinaemia include some antibiotics, local anaesthetics, nitrates in drinking water and pesticides.

The medicine can only be obtained with a prescription.

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How is it used?

Methylthioninium chloride Proveblueis injected slowly into a vein over a period of five minutes. It must be given by a healthcare professional.

The usual dose for adults and children aged above three months is 1 to 2 mg per kg body weight. A repeat dose may be given one hour after the first dose if symptoms persist or come back, or if the level of methaemoglobin in the blood stays higher than normal.

The dose in children aged three months or less is 0.3 to 0.5 mg/kg. They may also be given a repeat dose after one hour.

How does it work?

To carry oxygen in the blood, haemoglobin needs to contain an atom of iron in the ?ferrous? form (Fe 2+). Exposure to certain medicines or chemicals can cause the iron in the haemoglobin to change to the ?ferric? form (Fe 3+) seen in methaemoglobinaemia.

The active substance in Methylthioninium chloride Proveblue, methylthioninium chloride (also called methylene blue) helps speed up the conversion of abnormal haemoglobin back into normal haemoglobin. It does this by accepting negatively charged electron particles through an enzyme called ?NADPH methaemoglobinaemia reductase?. The electrons are then transferred to the iron atoms in the abnormal haemoglobin, converting them into the normal ferrous form.

How has it been studied?

Because methylthioninium chloride has been used in the European Union for several decades to treat methaemoglobinaemia, the company presented data on the use of methylthioninium chloride from published literature.

What benefits has it shown during the studies?

Reports from published literature confirmed that methylthioninium chloride is effective in treating methaemoglobinaemia that has been caused by exposure to a medicine or chemical in adults and children.

What is the risk associated?

The most common side effects with methylthioninium chloride are nausea (feeling sick), abdominal and chest pain, headache, dizziness, tremors, anxiety, confusional state, dyspnoea (difficulty breathing), tachycardia (rapid heartbeat), hypertension (high blood pressure), hyperhidrosis (excessive sweating) and the formation of methaemoglobinaemia. For the full list of all side effects reported with methylthioninium chloride, see the package leaflet.

Methylthioninium chloride Proveblue should not be used in people who may be hypersensitive (allergic) to methylthioninium chloride, or to any other thiazine dyes (a group to which methylthioninium chloride belongs). It must not be used in patients with the following conditions:

glucose-6-phosphate dehydrogenase deficiency G6PD,

methaemoglobinaemia caused by sodium nitrite,

methaemoglobinaemia caused by chlorate poisoning,

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deficiency in the enzyme NADPH reductase.

Why has it been approved?

The Committee concluded the long experience with the active substance, methylthioninium chloride, shows that it is effective in treating methaemoglobinaemia. The CHMP decided that the medicine?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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