What is Brintellix - vortioxetine used for?
Brintellix is a medicine containing 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 compromise all areas of daily life. The symptoms often reported are a pervasive sense of sadness, a sense of uselessness, loss of interest in favorite activities, sleep disturbances, the feeling of a slowdown in one's rhythms, anxiety, weight changes.
How is Brintellix - vortioxetine used?
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 older, an initial dose of 5 mg once a day should be used. Lower doses may also be required in patients taking certain medicines that reduce the degradation of vortioxetine in the body, while it may be useful to prescribe higher doses than patients taking medicines that increase the degradation of vortioxetine in the body. Treatment with Brintellix should continue for at least 6 months after resolution of the symptoms of depression. For more information, see the package leaflet.
How does Brintellix - vortioxetine work?
The active substance in Brintellix, vortioxetine, is an antidepressant. It acts on different serotonin receptors in the brain, blocking the action of some receptors and exerting a stimulating action on others. Furthermore, vortioxetine blocks the action of the serotonin transporter, which has the function of removing serotonin from its brain activity sites. By doing so, vortioxetine increases the activity of serotonin. Serotonin is a neurotransmitter, which is a chemical that transmits signals between nerve cells. Because serotonin contributes to mood control, and can regulate the actions of other transmitters involved in depression and anxiety, it is believed that these actions of vortioxetine have positive effects for improving 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 conducted on patients aged 65 and over), in which the medicine was compared with placebo ( fictitious treatment) for 6 or 8 weeks. The main measure of effectiveness in each study was the change in the standard score related to symptoms of depression; Studies showed that Brintellix doses between 5 and 20 mg were generally more effective than placebo in improving depression and resulted in a clinically relevant drop in depression scores. The data obtained in support of the use of the medicine in the 52-week extensions of some of these studies show that the improvements recorded were maintained even in the long term. Furthermore, the company presented the results of two other important studies. In a 12-week study in which Brintellix was compared to another antidepressant medicine, agomelatine, Brintellix was more effective than agomelatine in improving the symptom score. In a 24-week study comparing the efficacy of Brintellix with placebo in preventing relapse of depression, relapses during the study were observed in 13% of patients treated with Brintellix compared to 26% of subjects belonging to the treated group with placebo.
What is the risk associated with Brintellix - vortioxetine?
The most common side effect of 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 in the first two weeks of treatment. Intestinal effects such as nausea are more common in women than in men. Brintellix should be used with caution and dose adjustment is sometimes necessary in patients taking other medicines. Brintellix should not be used in people taking medicines known as non-selective inhibitors of mono-amino oxidases (MAOI) or selective monoamine oxidase A (MAO-A) inhibitors. For the full list of side effects and limitations, see the package leaflet.
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 a clinically relevant improvement in major depressive episodes, while the undesirable effects found were similar to those of other antidepressants acting through serotonin. The problem with the availability of only limited information 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 included in the summary of product characteristics and the package leaflet for Brintellix, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on 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 (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 01-2014.
