SEMGLEE™ SOLUTION FOR INJECTION IN A PREFILLED PEN 100U/ML

INJECTION, SOLUTION

**Posology and method of administration** - **Posology** Semglee™ contains insulin glargine, an insulin analogue, and has a prolonged duration of action. Semglee™ should be administered once daily at any time but at the same time each day. The pre-filled pen delivers insulin in increments of 1 unit up to a maximum single dose of 80 units. The dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, Semglee™ can also be given together with orally active antidiabetic medicinal products. The potency of this medicinal product is stated in units. These units are exclusive to insulin glargine and are not the same as international units or the units used to express the potency of other insulin analogues. **Special population** _Elderly population (≥ 65 years old)_ In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements. _Renal impairment_ In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism. _Hepatic impairment_ In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. **Children** In children, efficacy and safety of Semglee have only been demonstrated when given in the evening. Due to limited experience, the efficacy and safety of Semglee have not been demonstrated in children below the age of 6 years. **Switch from other insulins to Semglee™** When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with Semglee™, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products). **Switch from twice daily NPH insulin to Semglee™** To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Semglee™ should reduce their daily dose of basal insulin by 20–30% during the first weeks of treatment. **Switch from insulin glargine 300 units/ml to Semglee™** Semglee™ and insulin glargine 300 units/ml are not bioequivalent and are not directly interchangeable. To reduce the risk of hypoglycemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with Semglee™ should reduce their dose by approximately 20%. During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually. Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter. With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia (see section “special warnings and precautions for use” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Semglee™. - **Method of administration** Semglee™ is administered subcutaneously. Semglee™ should not be administered intravenously. The prolonged duration of action of Semglee™ is dependent on its injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia. There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of Semglee™. Injection sites must be rotated within a given injection area from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section Special warnings and precautions for use and Undesirable effects – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Semglee™ must not be mixed with any other insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.