Lyxumia

Posology Starting dose: dosing is initiated at 10 mcg lixisenatide once daily for 14 days. Maintenance dose: a fixed maintenance dose of 20 mcg lixisenatide once daily is started on Day 15. For the starting dose Lyxumia 10 micrograms solution for injection is available.

For the maintenance dose Lyxumia 20 micrograms solution for injection is available. When Lyxumia is added to existing metformin therapy, the current metformin dose can be continued unchanged. When Lyxumia is added to existing therapy of a sulphonylurea or a basal insulin, a reduction in the dose of the sulphonylurea or the basal insulin may be considered to reduce the risk of hypoglycaemia.

4). The use of Lyxumia does not require specific blood glucose monitoring. However, when used in combination with a sulphonylurea or a basal insulin, blood glucose monitoring or blood glucose self-monitoring may become necessary to adjust the doses of the sulphonylurea or the basal insulin.

Medicinal product no longer authorised 3 Special populations Elderly No dose adjustment is required based on age. Patients with renal impairment No dose adjustment is required for patients with mild or moderate renal impairment. 2). 1).

No data are available. Method of administration Lyxumia is to be injected subcutaneously in the thigh, abdomen or upper arm. Lyxumia should not be administered intravenously or intramuscularly. The injection is administered once daily, within the hour prior to any meal of the day.

It is preferable that the prandial injection of Lyxumia is performed before the same meal every day, when the most convenient meal has been chosen. If a dose is missed, it should be injected within the hour prior to the next meal.

Summary of the safety profile Over 2,600 patients have received Lyxumia either alone or in combination with metformin, a sulphonylurea (with or without metformin) or a basal insulin (with or without metformin, or with or without a sulphonylurea) in 8 large placebo- or active-controlled phase III studies.

The most frequently reported adverse reactions during clinical studies were nausea, vomiting and diarrhoea. These reactions were mostly mild and transient. In addition, hypoglycaemia (when Lyxumia was used in combination with a sulphonylurea and/or a basal insulin) and headache occurred.

4% of Lyxumia patients. Tabulated list of adverse reactions Adverse reactions reported from placebo- and active-controlled phase III studies over the entire treatment period are presented in Table 1. The table presents adverse reactions that occurred with an incidence >5% if the frequency was higher among Lyxumia treated patients than patients treated with all comparators.

The table also includes adverse reactions with a frequency ≥1% in the Lyxumia group if the frequency was greater than 2 times the frequency for all comparators group. Frequencies of adverse reactions are defined as: very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000).

Within each system organ class, adverse reactions are presented in order of decreasing frequency.

Table 1:

Adverse reactions reported in placebo- and active-controlled phase III studies during the entire treatment period (including the period beyond the main 24-week treatment period in studies with ≥76 weeks of total treatment). 6% of placebo treated patients.

8% of placebo patients during the entire treatment period. 6% absolute difference). 2% absolute difference). 5% absolute difference). 6% absolute difference). 2% in placebo patients) during the entire treatment period of the Phase III placebo-controlled studies.

There is no therapeutic experience with lixisenatide in patients with type 1 diabetes mellitus and it should not be used in these patients. Lixisenatide should not be used for treatment of diabetic ketoacidosis. Acute pancreatitis Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis.

There have been few reported events of acute pancreatitis with lixisenatide although a causal relationship has not been established. Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain.

If pancreatitis is suspected, lixisenatide should be discontinued; if acute pancreatitis is confirmed, lixisenatide should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Severe gastrointestinal disease Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.

Lixisenatide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of lixisenatide is not recommended in these patients. Renal impairment There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.

2). Medicinal product no longer authorised 4 Hypoglycaemia Patients receiving Lyxumia with a sulphonylurea or with a basal insulin may have an increased risk of hypoglycaemia. 2). Lixisenatide should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycaemia.

Concomitant medicinal products The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products. Lixisenatide should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption, require careful clinical monitoring or have a narrow therapeutic ratio.

1.