Active Ingredient: Lixisenatide
Lixisenatide is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together, with diet and exercise, do not provide adequate glycaemic control
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 10 micrograms lixisenatide, once daily -60 minutes before meals, over the duration of 14 days. Afterwards, subcutaneous, 20 micrograms lixisenatide, once daily -60 minutes before meals, over the duration of 14 days.
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.
When lixisenatide is added to existing metformin therapy, the current metformin dose can be continued unchanged.
When lixisenatide 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.
Lixisenatide should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycaemia.
The use of lixisenatide 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.
Lixisenatide is to be injected subcutaneously in the thigh, abdomen or upper arm. Lixisenatide 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 lixisenatide 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.
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