THERAPEUTIC INDICATIONS

Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.

POSOLOGY AND METHOD OF ADMINISTRATION

Lantus contains insulin glargine, an insulin analogue with a prolonged duration of action, administered subcutaneously, once daily the same time each day. Dosage and timing should be individually adjusted. In type 2 DM, Lantus can be given together with oral antidiabetic. Lantus must not be mixed with any other insulin or diluted. Lantus in cartridges and solostar pen are only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used. 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. When changing over to Lantus, amount and timing of short acting insulin or fast-acting insulin analogue or ofthe dose of any oral antidiabetic drug may need to be adjusted. Patients who are changing their basalinsulin regimen from twice daily NPH insulin should reduce their daily dose of basal insulin by 20-30%during first weeks of treatment. Lantus (100 units/ml) and insulin glargine 300 U/ml are not bioequivalent and are not directly interchangeable. When switching from Lantus XR to insulin glargine100 units/ml, the dose should be reduced (approximately by 20%) to reduce the risk of hypoglycaemia. 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. A program of close metabolic monitoring under medical supervision is recommended during transfer and in the initial weeks thereafter.

CONTRA-INDICATIONS

Hypersensitivity to insulin glargine or to any of the excipients.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Lantus is not for the treatment of diabetic ketoacidosis, use IV-administered regular insulin. In elderly, patients with renal impairment, hepatic impairment, insulin requirements may be diminished. In case of insufficient glucose control, review all other factors (injection technique, patient’s adherence) before considering dose adjustment. Hypoglycaemia is more likely to occur at the start of insulin treatment, patients should try to keep familiar with their individual warning symptoms. Insulin administration may cause insulin antibodies to form.

Hyperglycaemia may occur under certain circumtances: omission/reduction of injections or decreasein insulin effectiveness, pen malfunction, decreased physical activity, stress situations, injuries, operations, feverish illnesses or certain other diseases, and concurrent use of other medicines.

Intercurrent illness requires intensified metabolic monitoring. Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins.The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or visual impairment. It shouldbe considered whether it is advisable to drive or operate machinery in these circumstances.

INTERACTIONS

Enhancing blood-glucose-lowering effect: oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics. Reducing blood-glucose-lowering effect: corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic agents and thyroid hormones. Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia. Under the influence of sympatholytic agents such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

PREGNANCY AND LACTATION

Use of Lantus may be considered during pregnancy if necessary. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Lactating women may require adjustments in insulin dose and diet. Animal studies do not indicate direct harmful effects with respect to fertility.

UNDESIRABLE EFFECTS

Hypoglycaemia (very common), in general the most frequent undesirable effect of insulin therapy. Allergic reactions, temporary visual impairment, lipodystrophy and cutaneous amyloidosis, Injection site and alergic reactions, sodium retention and oedema, dysgeusia, and myalgia.

OVERDOSE

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 may be treated with intramuscular/subcutaneous glucagon on concentrated intravenous glucose.

PHARMACODYNAMIC PROPERTIES

ATC Code: A10A E04.

Presentation

Box, 1 vial @ 10 ml (DKI0259201443A1) Box, 5 cartridge @ 3 ml (DKI0259201443A2) Box, 5 solostar pen @ cartridge 3 ml (DKI0259201443A5) Manufactured by: Sanofi-Aventis Deutschland GmbH, Frankfurt (Main) Germany. More detailed Information on request: PT Aventis Pharma Jl. Jend. Ahmad Yani, Pulomas, Jakarta 13210 (021) 4892208 - 4895608 Date of revision: 17-Jan-2022 (based on BPOM approval 22-Des-21)

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

LANTUS