Therapeutic indications

Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.

Posology and Method of Administration

Posology Lantus XR 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, Lantus XR must be combined with short-/rapid-acting insulinto cover mealtime insulin requirements.

In patients with type 2 diabetes mellitus, Lantus XR can also be given together with otheranti- hyperglycaemic medicinal products.

The potency of this medicinal product is stated in units. These units are exclusive to Lantus XR and are not the same as IU or the units used to express the potency of other insulin analogues.

Flexibility in dosing time

When needed, patients can administer Lantus XR up to 3 hours before or after their usual timeof administration.

Patients who forget a dose, should be advised to check their blood sugar and then resume theirusual once-daily dosing schedule. Patients should be informed not to inject a double dose to make up for a forgotten dose.

Initiation Patients with type 1 diabetes mellitus

Lantus XR is to be used once-daily with meal-time insulin and requires individual doseadjustments.

Patients with type 2 diabetes mellitus.

The recommended daily starting dose is 0.2 units/kg followed by individual doseadjustments.

Switch between insulin glargine 100 units/ml and Lantus XR

Insulin glargine 100 units/ml and Lantus XR are not bioequivalent and are not directly interchangeable.

When switching from insulin glargine 100 units/ml to Lantus XR, this can be done ona unit-to-unit basis, but a higher Lantus XR dose (approximately 10-18%) may be neededto achieve target ranges for plasma glucose levels.
When switching from Lantus XR to insulin glargine 100 units/ml, the dose should be reduced (approximately by 20%) to reduce the risk of hypoglycaemia.

Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.

Switch from other basal insulins to Lantus XR

When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with Lantus XR, a change of the dose of the basal insulin may be required and the concomitant anti-hyperglycaemic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of non-insulin anti- hyperglycaemic medicinal products).

Switching from once-daily basal insulins to once-daily Lantus XR can be done unit- to- unit based on the previous basal insulin dose.
Switching from twice-daily basal insulins to once-daily Lantus XR, the recommended initial Lantus XR dose is 80% of the total daily dose of basal insulin that is being discontinued.

Patients with high insulin doses because of antibodies to human insulin may experiencean improved insulin response with Lantus XR.

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, if there is a change inthe timingof insulin dose or if other circumstances arise that increase susceptibility to hypo-or hyperglycaemia.

Switch from Lantus XR to other basal insulins

Medical supervision with close metabolic monitoring is recommended during the switch andin the initial weeks thereafter. Please refer to the prescribing information of the medicinal product to which the patient is switching.

Special populations

Lantus XR can be used in elderly people, renal and hepatic impaired patients, and children and adolescents from the age of 6 years.

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 toreduced capacity for gluconeogenesis and reduced insulin metabolism.

Paediatric population

Lantus XR can be used in adolescents and children from the age of 6 years based on the same principles as for adult patients. When switching basal insulin to Lantus XR, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to mimimize the risk of hypoglycaemia.

The safety and efficacy of Lantus XR in children below 6 years of age have not been established. No data are available.

Method of administration

Lantus XR is for subcutaneous use only. Lantus XR is administered subcutaneously by injection in the abdominal wall, the deltoid or the thigh. Injection sites must be rotated withina given injection area from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis.Lantus XR must not be administered intravenously.. Lantus XR must not be used in insulin infusion pumps.

Lantus XR is available in pre-filled pens. The dose window shows the number of units of Lantus XR to be injected. The Lantus XR SoloStar pre-filled pen has been specifically designed for Lantus XR, therefore no dose re-calculation is required.

CONTRA-INDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in section List of excipients.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Lantus XR is not the insulin of choice for the treatment of diabetic ketoacidosis.Instead,regular insulin administered intravenously is recommended in such cases.

In case of insufficient glucose control or a tendency to hyper-or hypoglycaemic episodes,thepatient's adherence to the prescribed treatment regimen, injection sites and properinjection technique and all other relevant factors must be reviewed before dose adjustment is considered. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions.

Hypoglycaemia The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed. Patients should be aware of circumstances where warning symptoms of hypoglycaemiaare diminished. The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups.

These include patients:

in whom glycaemic control is markedly improved,
in whom hypoglycaemia develops gradually,
who are elderly,
after transfer from animal insulin to human insulin,
in whom an autonomic neuropathy is present,
with a long history of diabetes,
suffering from a psychiatric illness,
receiving concurrent treatment with certain other medicinal products (see section
“Interaction with other medicinal products and other forms of Interaction”).

Factors increasing the susceptibility to hypoglycaemia require particularly closemonitoringand may necessitate dose adjustment. These factors include:

change in the injection area,
improved insulin sensitivity (e.g., by removal of stress factors),
unaccustomed, increased or prolonged physical activity,
intercurrent illness (e.g. vomiting, diarrhoea),
inadequate food intake,
missed meals,
alcohol consumption,
certain uncompensated endocrine disorders, (e.g. in hypothyroidism and in anterior pituitary
or adrenocortical insufficiency),
concomitant treatment with certain other medicinal products

Switch between insulin glargine 100 units/ml and Lantus XR Since insulin glargine 100 units/ml and Lantus XR are not bioequivalent and are not interchangeable, switching may result in the need for a change in dose and should only be done under strict medical supervision.

Switch between other insulins and Lantus XR Switching a patient between another typeor brand of insulin and Lantus XR should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal,human, human insulin analogue) and/or method of manufacture may result in the need fora change in dose.

Intercurrent illness Intercurrent illness requires intensified metabolic monitoring. In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.The insulin requirement is often increased. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even ifthey are ableto eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.

Insulin antibodies Insulin administration may cause insulin antibodies to form. In rare cases,the presence of such insulin antibodies may necessitate adjustment of the insulindose in order to correct a tendency to hyper-or hypoglycaemia.

Combination of Lantus XR with pioglitazone Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gainand oedema. Pioglitazone should be discontinued if any deterioration in cardiacsymptoms occurs.

Medication errors prevention. Insulin label must always be checked before each injectionto avoid medication errors between Lantus XR and other insulins (see section Special precautions for disposal andother handling).

A new sterile needle must be attached before each injection. Patients must also be instructedto not re-use needles. Re-use of needles increases the risk of blocked needles which may causeunderdosing or overdosing.

Patients must visually verify the number of selected units on the dose counter of the pen. Patients who are blind or have poor vision should be instructed to get help/assistance from another person who has good vision and is trained in using the insulin device.

DRUG INTERACTION

Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include anti-hyperglycaemic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics. Substancesthat may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones,atypical antipsychotic medicinal products (e.g. clozapine and olanzapine) and protease inhibitors. Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may causehypoglycaemia, which may sometimes be followed by hyperglycaemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter- regulation may be reduced or absent.

PREGNANCY AND LACTATION

The use of Lantus XR may be considered during pregnancy, if clinically needed. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Breast- feeding women may require adjustments in insulin dose and diet.

UNDESIRABLE EFFECTS

Very common : hypoglycaemia

Common : Lipohypertrophy, injection site reactions

Paediatric population

Safety and efficacy of Lantus XR have been demonstrated in a study in children aged 6 to lessthan 18 years. The frequency, type and severity of adverse reactions in the paediatric populationdo not indicate differences to the experience in the general diabetes populationClinical study safety data are not available for children under6 years.

Other special populations

Based on the results from clinical studies, the safety profile of Lantus XR in elderly patients and in patients with renal impairment was similar to that of the overall population.

OVERDOSAGE

Symptoms Insulin overdose may lead to severe and sometimes long-term and life- threatening hypoglycaemia.

Management 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 recurafter apparent clinical recovery.

PHARMACOLOGICAL PROPERTIES

Drugs used in diabetes, insulins and analogues for injection, long-acting. ATC Code:A10AE04.

Presentation :

Box, 5 pre-filled pen @ 1,5 mL Reg No. DKI1759201443B1 Manufactured by: Sanofi-Aventis Deutscland GmbH, Germany Registered by: PT. Aventis Pharma, Indonesia Date of Revision 17-Jan-2022 (as per BPOM Approval 22-Dec-2021)

This information is intended for Health Care Professional only. See local product information for full details information