Posology : מינונים

4.2     Posology and method of administration

Suliqua is available in two pre-filled pens, providing different dosing options, i.e., Suliqua (10-40) pen, Suliqua (30-60) pen respectively. The differentiation between the pen strengths is based on the dose range of the pen.
• Suliqua 100 units/ml + 50 micrograms/ml pre-filled pen delivers dose steps from 10-40 units of insulin glargine in combination with 5-20 mcg of lixisenatide (Suliqua (10-40) pen).
• Suliqua 100 units/ml + 33 micrograms/ml pre-filled pen delivers dose steps from 30-60 units of insulin glargine in combination with 10-20 mcg of lixisenatide (Suliqua (30-60) pen).

To avoid medication errors, the prescriber must make sure that the correct strength and number of dose steps is stated in the prescription (see section 4.4).

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 glucagon-like peptide-1 (GLP-1) receptor agonist or oral glucose lowering medicinal product other than metformin and SGLT-2 inhibitors should be discontinued prior to initiation of Suliqua.

The starting dose of Suliqua is based on previous anti-diabetic treatment, and in order not to exceed the recommended lixisenatide starting dose of 10 mcg:

Previous therapy
Insulin naïve          Insulin glargine          Insulin glargine patients (oral         (100 units/ml)**          (100 units/ml)** anti-diabetic          ≥20 to <30 units          ≥30 to ≤60 units treatment or
GLP-1 receptor agonist)

Suliqua               10 dose steps            20 dose steps
Starting        (10-40) pen         (10 units/5 mcg)*       (20 units/10 mcg)* dose and pen         Suliqua                                                                  30 dose steps (30-60) pen                                                           (30 units/10 mcg)* 
* Units insulin glargine (100 units/ml)/mcg lixisenatide
Patients on less than 20 Units of insulin glargine may be considered similar to insulin naive patients.

** If a different basal insulin was used:
• For twice daily basal insulin or insulin glargine (300 units/ml), the total daily dose previously used should be reduced by 20% to choose the Suliqua starting dose.
• For any other basal insulin, the same rule as for insulin glargine (100 units/ml) should be applied

The maximum daily dose is 60 units insulin glargine and 20 mcg lixisenatide corresponding to 60 dose steps.
Suliqua 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.

Dose titration
Suliqua 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 (see section 5.1).
Close glucose monitoring is recommended during the transfer and in the following weeks.

• If the patient starts with the Suliqua (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 Suliqua (30-60) pen.
• If the patient starts with the Suliqua (30-60) pen, the dose may be titrated up to 60 dose steps with this pen.
• For total daily doses >60 dose steps/day, Suliqua must not be used.

Patients adjusting the amount or timing of dosing should only do so under medical supervision with appropriate glucose monitoring (see section 4.4).

Missed dose
If a dose of Suliqua is missed, it should be injected within the hour prior to the next meal.

Special population
Elderly
Suliqua 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 Suliqua in patients ≥75 years of age is limited.

Renal impairment
Suliqua 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 Suliqua, frequent glucose monitoring and dose adjustment may be necessary.

Hepatic impairment
No dose adjustment of lixisenatide is needed in patients with hepatic impairment (see section 5.2). 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 Suliqua in patients with hepatic impairment.

Paediatric population
There is no relevant use of Suliqua in the paediatric population.

Method of administration
Suliqua is to be injected subcutaneously in the abdomen, deltoid, or thigh.

The injection sites should be rotated within the same region (abdomen, deltoid, or thigh) from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8).
Patients should be instructed to always use a new needle. The re-use of insulin pen needles increases the risk of blocked needles, which may cause under- or overdosing. In the event of blocked needles, patients must follow the instructions described in the Instructions for Use accompanying the package leaflet (see section 6.6).

Suliqua must not be drawn from the cartridge of the pre-filled pen into a syringe to avoid dosing errors and potential overdose (see section 4.4).