Lyxumia - Lixisenatide
What is Lyxumia - Lixisenatide?
Lyxumia is a medicine that contains the active substance lixisenatide. It is available as a solution for injection in pre-filled pens of 10 micrograms or 20 micrograms of lixisenatide per dose.
What is Lyxumia - Lixisenatide used for?
Lyxumia is indicated for the treatment of adult patients with type 2 diabetes to control blood glucose (sugar) levels. It is used in combination with oral antidiabetic agents and / or basal insulin (long-acting insulin) when these, together with diet and exercise, do not provide adequate control of blood glucose levels.
The medicine can only be obtained with a prescription.
How is Lyxumia used - Lixisenatide?
Lyxumia is given once a day, in the hour before the first meal of the day or evening meal. It is injected subcutaneously into the abdomen, upper arm or thigh. Lyxumia is given at a starting dose of 10 micrograms once a day, which is increased to 20 micrograms once a day after 14 days.
If Lyxumia is added to existing therapy with a sulfonylurea (another antidiabetic medicine) or a basal insulin, your doctor may decide to decrease the dose of the sulfonylurea or basal insulin to reduce the risk of hypoglycaemia (low concentration blood sugar).
This risk is not anticipated when Lyxumia is added to metformin therapy. Lyxumia must not be given in combination with a basal insulin associated with a sulfonylurea.
How does Lyxumia - Lixisenatide work?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or where the body is unable to use insulin effectively.
The active substance in Lyxumia, lixisenatide, is a 'GLP-1 receptor agonist'. It works by attaching to glucagon-like peptide 1 (GLP-1) receptors which are present on the surface of the cells of the pancreas and which are responsible for the production of insulin by this organ. When Lyxumia is given to the patient, the active substance lixisenatide reaches the receptors in the pancreas and activates them. This allows insulin to be released and helps to reduce blood glucose levels and thereby control type 2 diabetes.
How has Lyxumia - Lixisenatide been studied?
The effects of Lyxumia were first tested in experimental models before being studied in humans.
Lyxumia has been studied in seven main studies involving 3,825 adult patients with type 2 diabetes. Six studies compared Lyxumia with placebo (a substance that has no effect on the body), used alone or in combination with metformin. (a sulphonylurea), a 'basal insulin or a combination of two of these medicines in people who have not responded to previous therapy. In one study, Lyxumia was compared with another diabetes medicine, exenatide, in combination with metformin in patients whose blood sugar levels were not adequately controlled by metformin.
All of these studies measured the change in the concentration of glycosylated hemoglobin (HbA1c), which is the percentage of blood hemoglobin that is bound to glucose. HbA1c levels give an "indication of how well glucose is controlled in the blood. HbA1c levels were measured after 12 weeks, if Lyxumia was used alone, and after 24 weeks, if it was used in combination with others. antidiabetic medicines.
What benefit has Lyxumia - Lixisenatide shown during the studies?
Lyxumia was more effective than placebo at controlling blood glucose levels. Used alone, Lyxumia reduced HbA1c levels by 0.6% more than placebo. Used in combination with other antidiabetic medicines, Lyxumia helped reduce HbA1c levels by between 0.4% and 0.9% more than placebo.
A study comparing Lyxumia with exenatide (combined with metformin) showed a reduction in HbA1c levels of 0.79% after 24 weeks of treatment with Lyxumia compared to the value of 0.96% seen in patients treated with exenatide due times a day.
What is the risk associated with Lyxumia - Lixisenatide?
The most common side effects with Lyxumia (seen in more than 1 in 10 patients) are nausea, vomiting, diarrhea and headache. These side effects were mostly mild and generally transient. When Lyxumia was used in combination with a sulfonylurea or basal insulin, the most frequent side effect (seen in more than 1 in 10 patients) was hypoglycaemia (decreased blood sugar levels). They have been reported. allergic reactions in less than 1 in 100 patients treated with Lyxumia. For the full list of side effects reported with Lyxumia, see the package leaflet.
Lyxumia must not be used in people who are hypersensitive (allergic) to lixisenatide or any of the other ingredients.
Why has Lyxumia - Lixisenatide been approved?
The CHMP concluded that Lyxumia has been shown to be effective in lowering the blood glucose concentration in patients with type 2 diabetes, when used alone or in combination with other antidiabetic medicines. In addition, beneficial weight loss has been observed in patients treated with Lyxumia. Regarding the safety of the medicine, the side effects are mostly similar to those of other similar antidiabetic medicines and mainly affect the gut. The CHMP decided that Lyxumia's benefits are greater than its risks and recommended that it be released. of the marketing authorization for the medicinal product
More information about Lyxumia - Lixisenatide
On 1 February 2013, the European Commission issued a "Marketing Authorization" for Lyxumia, valid throughout the European Union.
For more information about Lyxumia therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 02-2013.
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