The incidence of treatment discontinuation due to adverse events was 7.4% for Lyxumia compared to 3.2% in the placebo group during the main 24-week treatment period. The most common adverse events which led to treatment discontinuation in the Lyxumia group were nausea (3.1%) and vomiting (1.2%). Lyxumia is to be injected subcutaneously in the thigh, abdomen or upper arm. Lyxumia should not be administered intravenously or intramuscularly. Lyxumia is administered once daily within the hour prior to the first meal of the day or the evening meal. The starting dose is 10 mcg (µg) Lyxumia once daily for 14 days. Then, the Lyxumia dose should be increased to 20 mcg (µg) once daily, which is the maintenance dose. If a dose of Lyxumia is missed, it should be injected within the hour prior to the next meal. When Lyxumia is added to existing metformin therapy, the current metformin dose can be continued unchanged. When Lyxumia is to a combination of a basal insulin and a sulphonylurea, a reduction in the dose of the basal insulin or the sulphonylurea may be considered according to individual response to reduce the risk of hypoglycaemia (see PRECAUTIONS). When used in combination with basal insulin and a sulphonylurea, blood glucose monitoring may become necessary to adjust the doses of the basal insulin or the sulphonylurea. In the absence of compatibility studies, Lyxumia must not be mixed with other medicinal products. Inspect Lyxumia before each use. Lyxumia must only be used if the solution is clear, colourless, with no particles visible. Lyxumia should not be used if it has been frozen. Lyxumia can be used with 29 to 32 gauge disposable pen needles. Pen needles are not included. The patient should be instructed to discard the needle after each use in accordance with local requirements and to store the pen without the needle attached. This helps prevent contamination and potential needle blockage.
The incidence of treatment discontinuation due to adverse events was 7.4% for Lyxumia compared to 3.2% in the placebo group during the main 24-week treatment period. The most common adverse events which led to treatment discontinuation in the Lyxumia group were nausea (3.1%) and vomiting (1.2%). Lyxumia is to be injected subcutaneously in the thigh, abdomen or upper arm. Lyxumia should not be administered intravenously or intramuscularly. Lyxumia is administered once daily within the hour prior to the first meal of the day or the evening meal. The starting dose is 10 mcg (µg) Lyxumia once daily for 14 days. Then, the Lyxumia dose should be increased to 20 mcg (µg) once daily, which is the maintenance dose. If a dose of Lyxumia is missed, it should be injected within the hour prior to the next meal. When Lyxumia is added to existing metformin therapy, the current metformin dose can be continued unchanged. When Lyxumia is to a combination of a basal insulin and a sulphonylurea, a reduction in the dose of the basal insulin or the sulphonylurea may be considered according to individual response to reduce the risk of hypoglycaemia (see PRECAUTIONS). When used in combination with basal insulin and a sulphonylurea, blood glucose monitoring may become necessary to adjust the doses of the basal insulin or the sulphonylurea. In the absence of compatibility studies, Lyxumia must not be mixed with other medicinal products. Inspect Lyxumia before each use. Lyxumia must only be used if the solution is clear, colourless, with no particles visible. Lyxumia should not be used if it has been frozen. Lyxumia can be used with 29 to 32 gauge disposable pen needles. Pen needles are not included. The patient should be instructed to discard the needle after each use in accordance with local requirements and to store the pen without the needle attached. This helps prevent contamination and potential needle blockage.
auspar-lixisenatide-130820-pi.docx