Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Lyxumia 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 (see sections 4.4 and 5.1 for available data on the different combinations).
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.
Lyxumia should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycaemia (see section 4.4).
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.
No dose adjustment is required based on age.
No dose adjustment is required for patients with mild or moderate 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 and therefore, it is not recommended to use lixisenatide in these populations (see section 5.2).
No dose adjustment is needed in patients with hepatic impairment (see section 5.2)
The safety and efficacy of lixisenatide in children and adolescents less than 18 years of age have not yet been established. No data are available.
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.
During clinical studies, doses up to 30 mcg of lixisenatide twice a day were administered to type 2 diabetic patients in a 13-week study. An increased incidence of gastrointestinal disorders was observed.
In case of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms and the lixisenatide dose should be reduced to the prescribed dose.
3 years.
After first use: 14 days.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store away from the freezer compartment.
After first use:
Store below 30°C. Do not freeze.
Do not store with a needle attached. Keep the cap on the pen in order to protect from light.
Type I glass cartridge with a (bromobutyl) rubber plunger, flanged caps (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the inside and polyisoprene on the outside). Each cartridge is assembled into a disposable pen.
Lyxumia 10 micrograms solution for injection: Each green pre-filled pen contains 3 ml solution, delivering 14 doses of 10 mcg. Pack containing 1 green pre-filled pen.
Lyxumia 20 micrograms solution for injection: Each purple pre-filled pen contains 3 ml solution, delivering 14 doses of 20 mcg. Packs containing 1, 2 and 6 purple pre-filled pens.
Not all pack sizes may be marketed.
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 pen is to be used for one patient only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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