Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
ABASAGLAR contains insulin glargine, an insulin analogue and has a prolonged duration of action.
ABASAGLAR should be administered once daily at any time but at the same time each day.
The dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, ABASAGLAR 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 IU or the units used to express the potency of other insulin analogues (see section 5.1).
In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
The safety and efficacy of insulin glargine have been established in adolescents and children aged 2 years and older (see section 5.1). The dose regimen (dose and timing) should be individually adjusted.
The safety and efficacy of insulin glargine have not been established No data are available.
When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with ABASAGLAR, 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 ABASAGLAR should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
ABASAGLAR 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 ABASAGLAR 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 (see section 4.4).
Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with ABASAGLAR.
ABASAGLAR is administered subcutaneously.
ABASAGLAR should not be administered intravenously. The prolonged duration of action of insulin glargine 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 insulin glargine.
Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8).
ABASAGLAR must not be mixed with any other insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.
For further details on handling, see section 6.6.
Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.
Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates. Adjustments in dose of the medicinal product, meal patterns, or physical activity may be needed.
More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
2 years.
Shelf life after first use:
The medicinal product may be stored for a maximum of 28 days up to 30°C and away from direct heat or direct light. Pens in use must not be stored in the refrigerator.
The pen cap must be put back on the pen after each injection in order to protect from light.
Before use:
Store in a refrigerator (2°C-8°C).
Do not freeze.
Do not store ABASAGLAR next to the freezer compartment or a freezer pack.
Keep the cartridge in the outer carton in order to protect from light.
In use:
For storage conditions after first opening of this medicinal product, see section 6.3.
3 mL solution in a cartridge (type 1 colourless glass) with a plunger (halobutyl rubber) and a disc seal (laminate of polyisoprene and halobutyl rubber) with aluminium seal.
Packs of 5 and 10 cartridges. Not all pack sizes may be marketed.
ABASAGLAR must not be mixed with any other insulin or medicinal products or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Insulin pen:
The ABASAGLAR cartridges are to be used only in conjunction with a Lilly reusable insulin pen (see section 4.4).
The pen should be used as recommended in the information provided with the device.
The instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
Cartridge:
Inspect the cartridge before use. It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency. Since ABASAGLAR is a solution, it does not require re-suspension before use. Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
To prevent the possible transmission of disease, each pen must be used by one patient only.
Empty cartridges must not be refilled and must be properly discarded. Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins (see section 4.4).
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