TRESIBA

What it is

Tresiba is an ultra-long acting basal insulin analogue, for once-daily subcutaneous administration at any time of the day. The active ingredient is insulin degludec. Tresiba is a clear, colourless, neutral solution. Tresiba is an ultra-long acting basal insulin that forms soluble multi-hexamers upon subcutaneous injection, resulting in a depot from which insulin degludec is continuously and slowly absorbed into the circulation leading to a flat and stable glucose lowering effect.

Approved indications

— Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year.

Dosing overview

Tresiba is an ultra-long acting basal insulin for once daily subcutaneous administration at any time of the day, preferably the same time every day, and is to be dosed in accordance with the individual patient's needs. For insulin naïve adults with type 2 diabetes mellitus, the recommended daily starting dose of Tresiba is 10 U, followed by individual dosage adjustments. For patients with type 1 diabetes mellitus, Tresiba is to be used once daily with mealtime insulin and requires subsequent individual dosage adjustments, and must be combined with short and/or rapid acting insulin to cover mealtime insulin requirements. For most patients with type 1 diabetes mellitus, a dose reduction of 20% based on the previous basal insulin dose, or basal component of a continuous subcutaneous insulin infusion regimen, should be considered with subsequent individual dosage adjustments based on the glycaemic response. Tresiba has a slow consistent rate of absorption which provides a flat and stable glucose-lowering-effect with a low variability, and allows for some flexibility in the timing of insulin administration, with patients having the option of changing the once daily injection time from day-to-day when needed.

Key safety warnings

Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia, and hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. As with other basal insulin products, the prolonged effect of Tresiba may delay recovery from hypoglycaemia. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement, and severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. Inadequate dosing or discontinuation of treatment in patients requiring insulin may lead to hyperglycaemia and potentially to diabetic ketoacidosis, and concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased insulin requirement. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis, and there is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. Weight gain can occur with any insulin therapy, including Tresiba, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.

Contraindications

Hypersensitivity to insulin degludec or any of the excipients.

PBS listing

Tresiba was recommended by PBAC in November 2017 for the treatment of type 1 and type 2 diabetes mellitus in adult patients requiring insulin, with a subsequent recommendation in July 2025 for type 1 diabetes mellitus.

Regulatory history

Tresiba Penfill, Tresiba FlexTouch 100 U/mL and Tresiba FlexTouch 200 U/mL were first listed on the ARTG on 29 November 2017. The product was recommended by PBAC in November 2017 for the treatment of type 1 and type 2 diabetes mellitus in adult patients requiring insulin. Tresiba is subject to additional monitoring in Australia, which will allow quick identification of new safety information. In July 2025, Tresiba was recommended by PBAC for type 1 diabetes mellitus on the basis of clinical need for an alternative form of insulin and was found to be cost-effective at the requested price. Tresiba FlexPen 100 U/mL was added to the ARTG on 6 March 2025.