Posology : מינונים

4.2      Posology and method of administration
Posology

Xultophy is given once daily by subcutaneous administration. Xultophy can be administered at any time of the day, preferably at the same time of the day.

Xultophy is to be dosed in accordance with the individual patient’s needs. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose.

Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.

Patients who forget a dose are advised to take it upon discovery and then resume their usual once-daily dosing schedule. A minimum of 8 hours between injections should always be ensured. This also applies when administration at the same time of the day is not possible.

Xultophy is administered as dose steps. One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide. The pre-filled pen can provide from 1 up to 50 dose steps in one injection in increments of one dose step. The maximum daily dose of Xultophy is 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). The dose counter on the pen shows the number of dose steps.

Add-on to oral glucose-lowering medicinal products
The recommended starting dose of Xultophy is 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide).

Xultophy can be added to existing oral antidiabetic treatment. When Xultophy is added to sulfonylurea therapy, a reduction in the dose of sulfonylurea should be considered (see section 4.4).

Transfer from GLP-1 receptor agonist
Therapy with GLP-1 receptor agonists should be discontinued prior to initiation of Xultophy. When transferring from a GLP-1 receptor agonist, the recommended starting dose of Xultophy is 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) (see section 5.1). The recommended starting dose should not be exceeded. If transferring from a long-acting GLP-1 receptor agonist (e.g. once- weekly dosing), the prolonged action should be considered. Treatment with Xultophy should be initiated at the moment the next dose of the long-acting GLP-1 receptor agonist would have been taken. Close glucose monitoring is recommended during the transfer and in the following weeks.

Transfer from any insulin regimen that includes a basal insulin component Therapy with other insulin regimens should be discontinued prior to initiation of Xultophy. When transferring from any other insulin therapy that includes a basal insulin component, the recommended starting dose of Xultophy is 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) (see section 4.4 and 5.1). The recommended starting dose should not be exceeded, but may be reduced to avoid hypoglycaemia in selected cases. Close glucose monitoring is recommended during the transfer and in the following weeks.

Special populations

Elderly patients (≥ 65 years old)
Xultophy can be used in elderly patients. Glucose monitoring is to be intensified and the dose adjusted on an individual basis.

Renal impairment
When Xultophy is used in patients with mild , moderate or severe renal impairment, glucose monitoring is to be intensified and the dose adjusted on an individual basis. Xultophy cannot be recommended for use in patients with end-stage renal disease (see sections 5.1 and 5.2).

Hepatic impairment
Xultophy can be used in patients with mild or moderate hepatic impairment. Glucose monitoring is to be intensified and the dose adjusted on an individual basis.
Due to the liraglutide component, Xultophy is not recommended for use in patients with severe hepatic impairment (see section 5.2).

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

Method of administration

Xultophy is for subcutaneous use only. Xultophy must not be administered intravenously or intramuscularly.

Xultophy is administered subcutaneously by injection in the thigh, the upper arm or the abdomen.
Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see sections 4.4 and 4.8). For further instructions on administration, see section 6.6.

Xultophy must not be drawn from the cartridge of the pre-filled pen into a syringe (see section 4.4).

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).