AWIQLI

What it is

Awiqli contains insulin icodec, with 1 mL solution containing 700 units of insulin icodec (equivalent to 26.8 mg insulin icodec). It is a solution for injection presented as a clear and colourless solution. Awiqli is a basal insulin for once-weekly subcutaneous administration. This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

— Treatment of Type 2 Diabetes in adults. — Treatment of Type 1 Diabetes in adults, in conjunction with a bolus insulin, where daily basal insulin injections are not suitable.

Dosing overview

Awiqli is a basal insulin for once-weekly subcutaneous administration, intended to be administered on the same day of the week. A dose of 10–700 units per injection, in steps of 10 unit increments, can be administered. In insulin-naïve patients with type 2 diabetes mellitus, the recommended weekly starting dose is 70 units and followed by individual once-weekly dose adjustments. In patients with type 1 diabetes mellitus, this medicinal product must be combined with bolus insulin to cover mealtime insulin requirements. In patients with type 2 diabetes, Awiqli can be administered alone or in any combination with oral antidiabetic medicinal products, GLP-1 receptor agonists and bolus insulin. When switching patients from once- or twice-daily basal insulin therapy, the first once-weekly dose should be administered on the day following the last dose of the previous basal insulin, with the recommended once-weekly Awiqli dose being 7 times the total daily basal dose of the previous basal insulin, rounded to the nearest 10 units.

Key safety warnings

Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. The risk of hypoglycaemia with insulin icodec corresponds to the weekly profile of its glucose-lowering effect, which reaches its maximum approximately 2–4 days after each weekly injection. Patient adherence to the dose and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia. The safety of insulin icodec in patients with hypoglycaemia unawareness has not been established, and treatment with insulin icodec is not recommended in such patients. Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycaemia and potentially to diabetic ketoacidosis. Untreated hyperglycaemia may eventually lead to diabetic ketoacidosis, which is potentially lethal. Allergic reactions may occur with all insulin preparations, and immediate-type allergic reactions to either insulin itself or the excipients may potentially be life-threatening. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis, as there is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. Patients must be instructed to always check the label on the insulin pen before each injection to avoid accidental mix-ups between once-weekly insulin icodec and other insulin products, particularly if they have been treated with other once-weekly injectable antidiabetic medicines.

Contraindications

Awiqli is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

PBS listing

Information regarding PBS listing is not provided in the available source documents.

Regulatory history

Awiqli received initial approval on 28 June 2024. Six strengths and presentations of Awiqli were registered on the Australian Register of Therapeutic Goods (ARTG) on 28 June 2024, comprising 700 units in 1 mL, 1050 units in 1.5 mL, and 2100 units in 3 mL solution for injection in pre-filled pens, with and without disposable needles.