Soliqua Dosage/Direction for Use

Posology: The dose must be individualised based on clinical response and is titrated based on the patient's need for insulin. The lixisenatide dose is increased or decreased along with insulin glargine dose and also depends on which pen is used.
Starting dose: Therapy with basal insulin or oral glucose lowering medicinal product other than metformin should be discontinued prior to initiation of Insulin Glargine + Lixisenatide (Soliqua).
The starting dose of Insulin Glargine + Lixisenatide (Soliqua) is based on previous anti-diabetic treatment, and in order not to exceed the recommended lixisenatide starting dose of 10 mcg: The maximum daily dose is 60 units insulin glargine and 20 mcg lixisenatide corresponding to 60 dose steps.
Insulin Glargine + Lixisenatide (Soliqua) should be injected once a day within one hour prior to a meal. It is preferable that the prandial injection is performed before the same meal every day, when the most convenient meal has been chosen.
Dosage titration: Insulin Glargine + Lixisenatide (Soliqua) is to be dosed in accordance with the individual patient's need for insulin. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose.
Close glucose monitoring is recommended during the transfer and in the following weeks.
If the patient starts with the Insulin Glargine + Lixisenatide (Soliqua) (10-40) pen, the dose may be titrated up to 40 dose steps with this pen.
For doses >40 dose steps/day titration must be continued with Insulin Glargine + Lixisenatide (Soliqua) (30-60) pen.
If the patient starts with the Insulin Glargine + Lixisenatide (Soliqua) (30-60) pen, the dose may be titrated up to 60 dose steps with this pen.
For total daily doses >60 dose steps/day, Insulin Glargine + Lixisenatide (Soliqua) must not be used. Patients adjusting the amount or timing of dosing should only do so under medical supervision.
Special population: Elderly (≥65 years old): Insulin Glargine + Lixisenatide (Soliqua) can be used in elderly patients. The dose should be adjusted on an individual basis, based on glucose monitoring. In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements. For lixisenatide no dose adjustment is required based on age. The therapeutic experience of Insulin Glargine + Lixisenatide (Soliqua) in patients ≥75 years of age is limited.
Renal impairment: Insulin Glargine + Lixisenatide (Soliqua) is not recommended in patients with severe renal impairment and end-stage renal disease as there is no sufficient therapeutic experience with use of lixisenatide. No dose adjustment is required for lixisenatide in patients with mild or moderate renal impairment. In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism. In patients with mild to moderate renal impairment using Insulin Glargine + Lixisenatide (Soliqua), frequent glucose monitoring and dose adjustment may be necessary.
Hepatic impairment: No dose adjustment of lixisenatide is needed in patients with hepatic impairment. In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. Frequent glucose monitoring and dose adjustment may be necessary for Insulin Glargine + Lixisenatide (Soliqua) in patients with hepatic impairment.
Paediatric population: There is no relevant use of Insulin Glargine + Lixisenatide (Soliqua) in the paediatric population.