Active Ingredient: Insulin glargine
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 0.2 international units insulin glargine per kilogram of body weight, once daily.
Insulin glargine is a basal insulin for once-daily administration at any time of the day, preferably at the same time every day.
The dose regimen (dose and timing) should be adjusted according to individual response.
In type 1 diabetes mellitus, insulin glargine must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements.
In patients with type 2 diabetes mellitus, insulin glargine can also be given together with other anti-hyperglycaemic 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 IU or the units used to express the potency of other insulin analogues.
Insulin glargine is to be used once-daily with meal-time insulin and requires individual dose adjustments.
The recommended daily starting dose is 0.2 units/kg followed by individual dose adjustments.
In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
The safety and efficacy of insulin glargine have been established in adolescents and children aged 2 years and older. The dose regimen (dose and timing) should be individually adjusted.
When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with insulin glargine 100 units/ml, 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).
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 insulin glargine 100 units/ml should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
Insulin glargine 100 units/ml and Toujeo (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 insulin glargine 100 units/ml 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 hypoglycaemia or hyperglycaemia.
Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with insulin glargine 100 units/ml.
Insulin glargine is administered subcutaneously by injection in the abdominal wall, the deltoid or the thigh. 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.
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