TOUJEO

What it is

Toujeo is insulin glargine 300 units/mL supplied as a sterile clear colourless solution for injection in a SoloStar pre-filled disposable pen injector containing 1.5 mL. Insulin glargine is produced by recombinant DNA technology in Escherichia coli. Insulin glargine 300 units/mL is a basal insulin for once-daily subcutaneous administration at any time of the day, preferably at the same time every day.

Approved indications

— Treatment of diabetes mellitus in patients 6 years of age and older.

Dosing overview

In type 1 diabetes mellitus, Toujeo is used once-daily as a basal insulin and requires subsequent individual dose adjustments. It must be combined with short or rapid-acting insulin to cover mealtime insulin requirements. In type 2 diabetes mellitus, the recommended daily starting dose is 0.2 U/kg followed by individual dosage adjustments. With Toujeo SoloStar pre-filled pen, a dose of 1 to 80 units per single injection, in steps of 1 unit, can be injected.

Key safety warnings

Toujeo must not be administered intravenously. The prolonged duration of action of Toujeo is dependent on its injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia. 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. 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 localised cutaneous amyloidosis. Do not inject into areas of lipodystrophy and localised cutaneous amyloidosis. Insulin glargine 300 units/mL must not be mixed with any other insulin products. Mixing changes the time or action profile of insulin glargine 300 units/mL and causes precipitation. Insulin glargine 300 units/mL must not be diluted. Diluting changes the time or action profile of insulin glargine 300 units/mL.

Contraindications

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

PBS listing

Toujeo is listed on the PBS in two strengths: injections (human analogue) 300 units per mL in 1.5 mL cartridges, available as a pack of 5 pens (item price A$73.06) or a pack of 3 pens (item price A$43.84). Both items are unrestricted.

Regulatory history

Toujeo SoloStar (insulin glargine 300 units/mL solution for injection injector pen) was first registered on the ARTG on 30 June 2015, with Toujeo Max SoloStar (insulin glargine 300 units/mL solution for injection injector pen) registered on 5 November 2019. In November 2017, the PBAC recommended Toujeo for the treatment of type 1 and type 2 diabetes mellitus in adult patients requiring insulin.