What is Brintellix and what is it used for?
Brintellix is a medicine that contains the active substance vortioxetine. It is indicated for the treatment of major depressive disorder in adults. In major depressive disorder, patients suffer from mood alterations that affect all areas of daily life. Symptoms often reported are a pervasive sense of sadness, a sense of worthlessness, loss of interest in favorite activities, sleep disturbances, the feeling of a slowing down of one's rhythms, anxiety, weight changes.
How is Brintellix used - vortioxetine?
Brintellix can only be obtained with a prescription and is available as tablets (5, 10, 15 and 20 mg) and oral drops (20 mg / ml). The starting dose is usually 10 mg once a day. In adult patients aged 65 years and above, a starting dose of 5 mg once daily should be used. Lower doses may also be needed in patients taking certain medicines that reduce the breakdown of vortioxetine in the body, while it may be useful to prescribe higher doses to patients taking medicines that increase the breakdown of vortioxetine in the body. Brintellix treatment should continue for at least 6 months after the symptoms of depression resolve. For more information, see the package leaflet.
How does Brintellix - vortioxetine work?
The active substance in Brintellix, vortioxetine, is an antidepressant. It acts on various serotonin receptors in the brain, blocking the action of some receptors and exerting a stimulating action on others. In addition, vortioxetine blocks the action of the serotonin transporter, which has the function of removing serotonin from its sites of activity in the brain. In doing so, vortioxetine increases the activity of serotonin. Serotonin is a neurotransmitter, which is a chemical that transmits signals between nerve cells. Since serotonin contributes to mood control, and may regulate the actions of other transmitters implicated in depression and anxiety, these actions of vortioxetine are believed to exert positive effects for the improvement of depression.
What benefit has Brintellix - vortioxetine shown during the studies?
Brintellix has been studied in 12 main short-term studies involving over 6,700 patients with major depressive disorder (including a study in patients aged 65 years and older), where the medicine was compared with placebo ( dummy treatment) for 6 to 8 weeks. The main measure of effectiveness in each study was the change in the standard score for symptoms of depression; the studies showed that doses of Brintellix between 5 and 20 mg were overall more effective than placebo in improving depression and determined a clinically relevant decline in depression scores. The data obtained in support of drug use in the 52-week extensions of some of these studies show that the improvements were maintained over the long term. In addition, the company presented the results of two other important studies. In a 12-week study in which Brintellix was compared with another antidepressant medicine, agomelatine, Brintellix was more effective than agomelatine in improving symptom score. In a 24-week study comparing the efficacy of Brintellix with placebo in preventing relapse of depression, relapses during the study were seen in 13% of patients treated with Brintellix compared with 26% of subjects in the treated group. with placebo.
What is the risk associated with Brintellix - vortioxetine?
The most common side effect with Brintellix (which may affect more than 1 in 10 people) is nausea. The side effects observed were usually mild or moderate, of short duration, and appeared within the first two weeks of treatment. gut like nausea is more common in women than in men. Brintellix should be used with caution and dose adjustment is sometimes required in patients taking other medicines. Brintellix should not be used in people taking medicines known as inhibitors non-selective monoamine oxidase (MAOI) inhibitors or selective monoamine oxidase A (MAO-A) inhibitors. See package leaflet for full list of side effects and limitations.
Why has Brintellix - vortioxetine been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Brintellix's benefits are greater than its risks and recommended that it be approved for use in the EU. Studies have shown clinically relevant improvement in depressive episodes. major, while the undesirable effects observed were similar to those of other antidepressants acting through serotonin. The issue of having only limited information available regarding the use of doses above 10 mg per day in the elderly is mentioned in the product information.
What measures are being taken to ensure the safe and effective use of Brintellix - vortioxetine?
A risk management plan has been developed to ensure that Brintellix 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 Brintellix, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Brintellix - vortioxetine
On December 18, 2013 the European Commission issued a "Marketing Authorization" for Brintellix, valid throughout the European Union. For more information on Brintellix therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 01-2014.
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