What is Mysimba and what is it used for - naltrexone, bupropion?
Mysimba is a medicine indicated, in addition to diet and physical activity, to promote the management of body weight in adult patients:
- obese (with a body mass index - BMI - of 30 or more);
- overweight (BMI between 27 and 30) and with weight-related complications such as diabetes, abnormally high blood fat levels or high blood pressure.
BMI is a parameter that provides information on body weight in relation to height. Mysimba contains the active substances naltrexone and bupropion, which are individually authorized in the EU for other uses.
How is Mysimba used - naltrexone, bupropion?
Mysimba is available as prolonged-release tablets containing 7.2 mg of naltrexone and 78 mg of bupropion and can only be obtained with a prescription. The term "sustained release" means that naltrexone and bupropion are released slowly from the tablet over a period of several hours.
Treatment with Mysimba begins with taking a single tablet in the morning. The dose is gradually increased over the course of 4 weeks to reach the recommended dose of two tablets twice a day, preferably taken with food. The response to treatment and the tolerability of the medicinal product should be monitored periodically; in patients who develop certain undesirable effects, such as an increase in blood pressure, the treatment should be stopped. Mysimba treatment should also be discontinued if patients have not lost at least 5% of their initial body weight after 4 months of therapy. For more information, see the package leaflet.
How does Mysimba work - naltrexone, bupropion?
The exact mechanism of action of Mysimba is not fully known, but the two active ingredients, naltrexone and bupropion, act on the brain areas that regulate food intake and energy balance, as well as reducing the activity of the brain centers. that control the sensation of pleasure associated with the consumption of food. The action of the two active ingredients administered simultaneously causes a reduction in appetite and the amount of food consumed by patients and increases their energy expenditure, helping them to adhere to a low-calorie diet and lose weight.
What benefit has Mysimba shown - naltrexone, bupropion shown during the studies?
The effects of Mysimba in reducing body weight were demonstrated in 4 main studies involving around 4 500 obese or overweight patients, in which Mysimba was compared with a placebo (a dummy treatment). studies took the medicine as part of a weight control program, which included a cycle of sessions and counseling on diet and physical activity. The main parameters of effectiveness were the percentage reduction in body weight over a period of 28 o 56 weeks of treatment and the number of patients who had a weight loss of at least 5%. The studies also took into account the number of patients who achieved greater weight loss, of at least 10%, and the results were analyzed using various methods, in order to take into account the number of patients who did not complete the studies (approximately 50% over the course of a year). of these studies, the mean weight loss of patients treated with Mysimba was between 3.7 and 5.7% compared with 1.3-1.9% seen with placebo. The percentage of Mysimba-treated patients who lost at least 5% of their original weight ranged from 28 to 42% compared with 12-14% of placebo-treated patients. About 13-22% of the Mysimba-treated subjects lost at least 10% of their starting weight compared to 5-6% of the placebo-treated subjects.In the other study, which involved a more intense cycle of sessions, the overall weight loss was greater over the course of the study: 8.1% with Mysimba and 4.9% with placebo. Approximately 46% and 30% of the Mysimba-treated patients achieved a weight reduction of 5% and 10%, respectively, compared with 34% and 17% of the placebo-treated patients, respectively. The extent of improvement with Mysimba compared to placebo was similar with the use of different test methods, although more modest benefits were seen with the more conservative methods (which ruled out any signs of improvement in patients who did not complete the test. study). Treatment efficacy was most marked in subjects who completed 56 weeks of treatment or who lost at least 5% of their original body weight over 4 months.
What is the risk associated with Mysimba - naltrexone, bupropion?
The most common side effects with Mysimba (which may affect more than 1 in 10 people) are nausea, vomiting and constipation; equally common (seen in up to 1 in 10 people) are dizziness and dry mouth. For the full list of side effects reported with Mysimba, see the package leaflet. Mysimba should not be used in certain individuals at high risk of side effects, including patients with severe renal or hepatic impairment, people with high blood pressure uncontrolled, people who have had seizures or suffering from psychological disorders or a brain tumor, or individuals who have recently stopped taking alcohol or certain drugs. For the full list of restrictions, see the package leaflet.
Why has Mysimba - naltrexone, bupropion been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) is of the opinion that the efficacy of the medicine in promoting weight loss, while limited, is sufficient to be considered clinically significant and that the obligation to re-evaluate the treatment after a 4-month course it should in itself ensure that the medicine continues to be used only in subjects where adequate benefit is observed. Regarding safety, although it is concerned about possible cardiovascular effects (cardiovascular outcomes) and for a slightly increased risk of seizures, the CHMP considers the most common side effects to be largely manageable, as patients can discontinue therapy in the event that they become bothersome. The interim results of an ongoing cardiovascular outcomes study were analyzed during an evaluation; despite this, the CHMP also recommended constant monitoring of the medicine's cardiovascular effects. In light of the available evidence, the CHMP decided that Mysimba's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Mysimba - naltrexone, bupropion?
A risk management plan has been developed to ensure that Mysimba 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 Mysimba, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Mysimba will prepare an information pack for doctors prescribing the medicine, including a guidance document on stopping treatment in people who do not respond to treatment or who are concerned about side effects. The company will also carry out a review. further study to evaluate the effect of the medicine on the heart and blood vessels. Further information can be found in the summary of the risk management plan.
Other information about Mysimba - naltrexone, bupropion
On 26 March 2015, the European Commission issued a "Marketing Authorization" for Mysimba, valid throughout the European Union. For the full version of the EPAR and the summary of the Mysimba Risk Management Plan, please visit the website Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Mysimba therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. Last update of this summary: 03-2015
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