Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Lantus contains insulin glargine, an insulin analogue, and has a prolonged duration of action. Lantus 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, Lantus 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 Lantus 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.
Safety and efficacy of Lantus 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 Lantus 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 Lantus, 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 Lantus should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
Lantus 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 Lantus 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 4.4).
Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Lantus.
Lantus is administered subcutaneously.
Lantus should not be administered intravenously. The prolonged duration of action of Lantus 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 Lantus. 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 4.4 and 4.8).
Lantus 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.
Lantus 100 units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used (see section 4.4).
For further details on handling, see section 6.6.
Lantus SoloStar 100 units/ml in pre-filled pen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used (see section 4.4). Before using SoloStar, the instructions for use included in the package leaflet must be read carefully (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.
5 ml vial: 2 years.
10 ml vial 3 years.
5 ml vial: The medicinal product may be stored for a maximum of 4 weeks not above 25°C and away from direct heat or direct light. Keep the vial in the outer carton in order to protect from light.
10 ml vial: The medicinal product may be stored for a maximum of 4 weeks not above 30°C and away from direct heat or direct light. Keep the vial in the outer carton in order to protect from light.
It is recommended that the date of the first use from the vial be noted on the label.
3 years.
The medicinal product may be stored for a maximum of 4 weeks not above 30°C and away from direct heat or direct light.
The pen containing a cartridge or the 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.
Unopened vials, unopened cartridges, not in-use SoloStar pens:
Store in a refrigerator (2°C-8°C).
Do not freeze or place next to the freezer compartment or a freezer pack.
Keep the vial, cartridge or SoloStar pre-filled pen in the outer carton in order to protect from light.
Opened vials, in-use cartridges or SoloStar pens:
For storage conditions after first opening of this medicinal product, see section 6.3.
5 ml vial: Type 1 colourless glass vial with a flanged cap (aluminium), a stopper (chlorobutyl rubber (type 1)) and a tear-off cap (polypropylene) containing 5 ml of solution.
Packs of 1, 2, 5 and 10 vials.
10 ml vial: Type 1 colourless glass vial with a flanged cap (aluminium), a stopper (type 1, laminate of polyisoprene and bromobutyl rubber) and a tear-off cap (polypropylene) containing 10 ml of solution.
Pack of 1 vial.
Not all pack sizes may be marketed.
Type 1 colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber) containing 3 ml of solution.
Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges.
Not all pack sizes may be marketed.
Type 1 colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber) containing 3 ml of solution.
The cartridge is sealed in a disposable pen injector. Needles are not included in the pack.
Packs of 1, 3, 4, 5, 6, 8, 9 and 10 SoloStar pre-filled pens.
Not all pack sizes may be marketed.
Inspect Lantus 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 Lantus is a solution, it does not require resuspension before use.
Lantus must not be mixed with any other insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins (see section 4.4).
Lantus 100 units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used. The Lantus cartridges are to be used only in conjunction with the pens: ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO or JuniorSTAR (see section 4.2 and 4.4). Not all of these pens may be marketed in your country.
The pen should be used as recommended in the information provided by the device manufacturer.
The manufacturer’s 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.
Before insertion into the pen, the cartridge must be stored at room temperature for 1 to 2 hours. Air bubbles must be removed from the cartridge before injection (see instructions for using the pen). Empty cartridges must not be refilled.
Lantus SoloStar 100 units/ml in pre-filled pen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used (see section 4.2 and 4.4). Before first use, the pre-filled pen must be stored at room temperature for 1 to 2 hours. Empty pre-filled pens must never be reused and must be properly discarded. To prevent the possible transmission of disease, each pen must be used by one patient only. Before using the pre-filled pen, the instructions for use included in the package leaflet must be read carefully.
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