What is Mirvaso - brimonidine tartrate and what is it used for?
Mirvaso is a medicine that contains the active substance brimonidine tartrate. It is indicated for the treatment of facial erythema (redness of the skin of the face) in adults with rosacea, a long-term pathological change of the skin that often causes flushing and redness.
How is Mirvaso used - brimonidine tartrate?
Mirvaso is available as a gel (3 mg / g) and can only be obtained with a prescription. Mirvaso should only be applied to the skin of the face. A small amount of gel, about the size of a small pea, should be applied in a thin layer to the skin of the forehead, chin, nose and cheeks. Before applying other creams or cosmetics, the affected areas should be allowed to dry. For more information, see the package leaflet.
How does Mirvaso - brimonidine tartrate work?
Rosacea is an alteration that mainly affects the skin of the face. Its symptoms include episodes of redness that have been linked to the dilation of the small blood vessels that supply the skin of the face, with a consequent increase in the flow. of blood in the affected area.
The active substance in Mirvaso, brimonidine tartrate, works by attaching to and activating certain receptors, called alpha2-adrenergic receptors, found on the blood vessel cells of the skin. Doing so causes blood vessels to narrow, which reduces the flow of blood to the face, thus decreasing redness.
What benefit has Mirvaso - brimonidine tartrate shown during the studies?
Mirvaso was studied in two main studies involving a total of 553 patients with moderate to severe rosacea-induced redness. Both studies compared Mirvaso with placebo (a dummy gel) over a four-week period of treatment. . The main measure of effectiveness was the percentage of patients in whom a marked reduction in facial redness was observed 3, 6, 9 and 12 hours after application on days 1, 15 and 29 from the start of therapy. In both studies, Mirvaso, applied once daily, was more effective than placebo in reducing facial redness in these patients.
- In the context of the first study, a reduction in facial redness was observed 3 hours after the first application (day 1) in 16.3% (21 out of 129) of patients treated with Mirvaso compared to 3.1% (4 out of 131) treated with placebo. The effect lasted for 12 hours after application, although it began to wear off after 6 hours. On day 29, 31.5% (40 out of 127) of patients showed a reduction in facial redness 3 hours after application with Mirvaso compared to a response of 10.9% (14 out of 128) recorded with the placebo.
- In the second study, a reduction in facial redness was observed 3 hours after the first application (day 1) in 19.6% (29 out of 148 patients) of patients treated with Mirvaso compared to 0% ( none of 145 patients) treated with placebo. Also in this case, the positive effect lasted 12 hours after application, although it began to fade after 6 hours. On day 29, 25.4% (36 out of 142) of patients showed a reduction in facial redness 3 hours after application with Mirvaso compared to a response of 9.2% (13 out of 142) recorded with the placebo.
What is the risk associated with Mirvaso - brimonidine tartrate?
The most common side effects with Mirvaso (which may affect more than 1 100 people), usually mild to moderate in degree, are erythema (redness), itching, flushing and burning sensation of the skin. For the full list of side effects reported with Mirvaso, see the package leaflet. Mirvaso should not be used in children under 2 years of age or in patients being treated with other medicines including monoamine oxidase (MAO) inhibitors or certain antidepressants Treatment with Mirvaso is not indicated in children or adolescents aged 2 to 18. See the package leaflet for the full list of restrictions.
Why has Mirvaso - brimonidine tartrate been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Mirvaso's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Mirvaso improves the redness of the skin. face in rosacea patients. Regarding safety, the CHMP acknowledged that the safety profile is acceptable as the adverse events reported are local disorders, ie affecting the skin, and are similar to those usually seen with other topical medicines used in the treatment of rosacea. .
What measures are being taken to ensure the safe and effective use of Mirvaso - brimonidine tartrate?
A risk management plan has been developed to ensure that Mirvaso is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Mirvaso, 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.
More information about Mirvaso - brimonidine tartrate
On 21 February 2014, the European Commission issued a "Marketing Authorization" for Mirvaso, valid throughout the European Union. For more information on Mirvaso therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 02-2014.
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