Lantus

/ Sanofi

Administer once daily at any time but at the same time each day. Dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, can also be given together with orally active antidiabetic medicinal products. Administer subcutaneously, do not administer intravenously as the prolonged duration of action is dependent on its injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia.
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 to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Pediatric population: Safety and efficacy have been established in adolescents and children of 6 years and above. In children, efficacy and safety have only been demonstrated when given in the evening. Due to limited experience on the efficacy and safety in children below the age of 6 years, it should only be used in this age group under careful medical supervision.
See prescribing information for full details.

Treatment of adult and pediatric patients, 6 years and over, with type 1 diabetes mellitus or adults patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia.

Hypersensitivity to the active substance or to any of the excipients.

Lantus is not the insulin of choice for the treatment of diabetic ketoacidosis, children, in patients with impaired liver function, moderate/severe renal impairment. Intensified blood glucose monitoring is advisable in patients in whom hypoglycemic episodes might be of particular clinical relevance, patients with proliferative retinopathy, patients should be aware of circumstances where warning symptoms of hypoglycemia are diminished. Prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycemia. Adherence of the patients to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycemia symptoms are essential to reduce the risk of hypoglycemia. Pregnancy and lactation, ability to concentrate and react may be impaired as a result of hypoglycemia and hyperglycemia.

Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
For full details see prescribing information.

A number of substances affect glucose metabolism and may require dose adjustment of insulin glargine. Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics. Substances that 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. olanzapine and clozapine) and protease inhibitors. Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucoselowering effect of insulin. Pentamidine may cause hypoglycaemia, 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: For insulin glargine no clinical data on exposed pregnancies from controlled clinical trials are available. A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine. The use may be considered during pregnancy, if clinically needed. It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycemia. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential.
Lactation: It is unknown whether insulin glargine is excreted in human milk. No metabolic effects of ingested insulin glargine on the breastfed newborn/infant are anticipated since insulin glargine as a peptide is digested into amino acids in the human gastrointestinal tract. Breastfeeding women may require adjustments in insulin dose and diet. See prescribing information for full details.
Fertility: Animal studies do not indicate direct harmful effects with respect to fertility.

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 recur after apparent clinical recovery.

Storage:
Vials
Unopened vials: 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 in the outer carton in order to protect from light.
Opened vials: For storage conditions after first opening, see prescribing information.
Cartridges
Unopened cartridges: Store in a refrigerator (2°C-8°C). Do not freeze or place next to the freezer compartment or a freezer pack. Keep the cartridge in the outer carton in order to protect from light.
In-use cartridges: For storage conditions after first opening, see prescribing information..
Pre-filled pens
Not in-use 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 pre-filled-pen in the outer carton in order to protect from light.
In-use pens: For storage conditions after first opening, see prescribing information.