LEVEMIR

What it is

Levemir is a soluble, basal insulin analogue with a prolonged duration of effect. Insulin detemir is produced by recombinant DNA technology using *Saccharomyces cerevisiae*. Levemir is a clear, colourless, neutral solution of insulin detemir 100 U/mL.

Approved indications

— Treatment of diabetes mellitus.

Dosing overview

Levemir is a long-acting insulin analogue used alone as a basal insulin or in combination with bolus insulin. It can also be used in combination with oral antidiabetic drugs or as add-on therapy to liraglutide. For patients with type 1 diabetes mellitus, Levemir must be used in combination with rapid- or short-acting insulin. When Levemir is used as part of a basal-bolus insulin regimen, Levemir should be administered once or twice daily depending on patients' needs. In combination with oral antidiabetic drugs or as add-on therapy to liraglutide in type 2 diabetes, it is recommended to initiate Levemir treatment with once daily administration at a dose of 10 U or 0.1–0.2 U/kg. The dose of Levemir should be titrated based on individual patients' needs.

Key safety warnings

Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis. In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia. Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. Levemir is not to be administered intravenously as it may result in severe hypoglycaemia. Levemir is not to be used in insulin infusion pumps. 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. Cases of congestive heart failure have been reported when thiazolidinediones were used in combination with insulin, especially in patients with risk factors for development of congestive heart failure. This should be kept in mind if treatment with the combination of thiazolidinediones and insulin medicinal products is considered. If the combination is used, patients should be observed for signs and symptoms of congestive heart failure, weight gain and oedema.

Contraindications

Hypersensitivity to insulin detemir or any of the excipients.

PBS listing

Levemir is listed on the PBS as injections (human analogue), cartridges, 100 units per mL, 3 mL, 5, with 2 PBS items. The restriction type is restricted, and the ex-manufacturer price is A$61.61.

Regulatory history

Levemir FlexPen and Levemir Penfill (both insulin detemir 100 U/mL injection cartridges) were first listed on the ARTG on 9 September 2011.