What is Saxenda - liraglutide and what is it used for?
Saxenda is an indicated medicine, in addition to diet and physical activity, to promote weight management in adult patients:
- obese (with a body mass index - BMI - 30 or more);
- overweight (BMI between 27 and 30) and weight-related complications such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnea (frequent interruption of breathing during sleep).
The BMI is a parameter that provides information on body weight in relation to height. Saxenda contains the active substance liraglutide.
How is Saxenda - liraglutide used?
Saxenda is available as a solution for injection in pre-filled pens. The medicine can only be obtained with a prescription. Saxenda is given once a day, preferably at the same time of day. It is given by subcutaneous injection in the thigh, upper arm or abdomen. The initial dose is 0.6 mg a day. Thereafter the dose should be increased up to 3.0 mg per day in 0.6 mg increments at one week intervals.
Treatment with Saxenda should be discontinued if patients have not lost at least 5% of their initial body weight after 12 weeks of therapy at the Saxenda 3.0 mg dose per day. The doctor must periodically evaluate the need to continue the treatment.
How does Saxenda - liraglutide work?
The active substance in Saxenda, liraglutide, is a "GLP-1 receptor agonist (peptide-1 type glucagon)", which is already authorized in the EU at lower doses (up to 1.8 mg a day) with the name Victoza for the treatment of type 2 diabetes. The exact mechanism of action of Saxenda in weight loss is not fully known, but it is believed that the medicine acts on the brain areas that regulate appetite, binding to receptors of GLP-1 present in brain cells. The result is an increase in the feeling of satiety and a decrease in hunger signals.
What benefit has Saxenda - liraglutide shown during the studies?
Saxenda has been shown to be effective in reducing body weight in 5 main studies involving over 5, 800 obese or overweight patients. In these studies, up to 56 weeks in duration, Saxenda was compared with placebo (a dummy treatment). Participants in the studies took the medicine as part of a weight control program that included a cycle of sessions and counseling on diet and physical activity. Taking the results of the 5 studies together, Saxenda taken at a daily dose of 3 mg resulted in a 7.5% reduction in body weight compared to the 2.3% reduction observed in placebo-treated patients. In subjects treated with Saxenda there was a continuous decrease in body weight in the first 40 weeks of treatment, at the end of which the weight reached was maintained. Weight loss was more pronounced in women than in men. When data from the main studies were re-analyzed using a more conservative method, which excluded any signs of improvement in patients who had not completed the study (about 30%), similar weight decreases were observed, although more limited, in the group treated with Saxenda.
What is the risk associated with Saxenda - liraglutide?
The most common side effects with Saxenda (which may affect more than 1 in 10 people) are nausea, vomiting, diarrhea and constipation. For the full list of all side effects and restrictions with Saxenda, see the package leaflet.
Why has Saxenda - liraglutide been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Saxenda's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP has determined that Saxenda produces a modest effect (especially in men) and yet clinically relevant in terms of decreasing body weight. As for safety, the most common side effects of Saxenda (such as nausea) are related to the stomach and intestines. To limit these effects, the Saxenda dose should be gradually increased over 4 weeks at the start of therapy. An ongoing study with Victoza should provide more information on the safety of liraglutide over the long term (especially with regards to its effects on the heart and blood vessels).
What measures are being taken to ensure the safe and effective use of Saxenda - liraglutide?
A risk management plan has been developed to ensure that Saxenda 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 Saxenda, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan
Other information on Saxenda - liraglutide
On March 23, 2015, the European Commission issued a marketing authorization for Saxenda, valid throughout the European Union. For the full version of the EPAR and the summary of the Saxenda risk management plan, consult the website of the Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Saxenda, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 03-2015
