BASAGLAR

# BASAGLAR Brand Dossier

What it is

BASAGLAR is insulin glargine 100 units/mL supplied as a solution for injection in cartridges for use as an injection. Insulin glargine is produced by recombinant DNA technology in Escherichia coli. Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH. The onset of action of subcutaneous insulin glargine 100 units/mL is slower than with NPH insulin, its effect profile is smooth and peakless, and the duration of its effect is prolonged.

Approved indications —

Type 1 diabetes mellitus in adults and children — Type 2 diabetes mellitus in adults who require insulin for the control of hyperglycaemia

Dosing overview

BASAGLAR is a basal insulin for once-daily subcutaneous administration at any time of the day, preferably at the same time every day. The recommended daily starting dose for patients with type 2 diabetes mellitus is 0.2 U/kg followed by individual dosage adjustments. In type 1 diabetes mellitus, BASAGLAR is to be used once-daily as a basal insulin and requires subsequent individual dose adjustments, and must be combined with short/rapid-acting insulin to cover mealtime insulin requirements.

Key safety warnings

Severe hypoglycaemic episodes, especially if recurrent, may lead to neurological damage. Prolonged or severe hypoglycaemic episodes may be life-threatening. Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished. The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups including patients in whom glycaemic control is markedly improved, in whom hypoglycaemia develops gradually, who are elderly, in whom an autonomic neuropathy is present, with a long history of diabetes, suffering from a psychiatric illness, or receiving concurrent treatment with certain other medicinal products. Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and localised cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. BASAGLAR is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular insulin administered intravenously is recommended in such cases.

Contraindications

BASAGLAR must not be used in patients hypersensitive to insulin glargine or any of the excipients.

PBS listing

BASAGLAR insulin glargine 100 IU/mL solution for injection cartridge was first listed on the ARTG on 2014-11-21. Information on specific PBS item numbers, restriction types, and ex-manufacturer pricing is not contained in the provided source documents.

Regulatory history

BASAGLAR was approved by the TGA on 2014-11-10 for once-daily subcutaneous administration in the treatment of Type 1 diabetes mellitus in adults and children and Type 2 diabetes mellitus in adults who require insulin for the control of hyperglycaemia. The TGA approved BASAGLAR as a biosimilar, concluding that its benefits outweigh the risks for the treatment of Type 1 and Type 2 diabetes mellitus. The approval was supported by evidence of physicochemical, nonclinical, and clinical comparability to Lantus. In November 2017, the PBAC recommended BASAGLAR based on a price reduction.