Posology : מינונים

4.2 Posology and method of administration

Posology

Starting dose: dosing is initiated at 10 mcg Lyxumia once daily for 14 days.
If Starting dose is not optional, the physician should consider alternative therapies for these patients.

Maintenance dose: a fixed maintenance dose of 20 mcg Lyxumia once daily is started on Day 15.
Lyxumia 20 micrograms solution for injection is available for the maintenance dose.

Lyxumia 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 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 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 hypoglycemia.
Lyxumia should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycemia (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.

Special populations

Elderly patients(≥65 years)
No dose adjustment is required based on age. The clinical experience in patients ≥75 years is limited (see sections 5.1 and 5.2).

Patients with renal impairment

No dose adjustment is required for patients with mild renal impairment (creatinine clearance : 50-80 ml/min).

There is limited therapeutic experience in patients with moderate renal impairment (creatinine clearance: 30-50 ml/min) and Lyxumia should be used with caution in this population.

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 Lyxumia in these populations (see section 5.2).

Patients with hepatic impairment

No dose adjustment is needed in patients with hepatic impairment (see section 5.2) 
Pediatric population

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.

Method of administration

Lyxumia is to be injected subcutaneously in the thigh, abdomen or upper arm. Lyxumia should not be administered intravenously or intramuscularly.