TRULICITY

What it is

TRULICITY contains dulaglutide (rch) 1.5 mg per 0.5 mL solution. It is a solution for injection that is clear, colourless, essentially free from particles, sterile and non-pyrogenic for subcutaneous administration. Dulaglutide is a long acting GLP-1 receptor agonist.

Approved indications

— Improvement of glycaemic control in adults with type 2 diabetes mellitus as monotherapy, as an adjunct to diet and exercise. — Improvement of glycaemic control in adults with type 2 diabetes mellitus in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. — Reduction of the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors, as an adjunct to standard of care therapy.

Dosing overview

The recommended dose of TRULICITY for adults is 1.5 mg per week, administered once weekly at any time of day, independently of meals. The dose can be administered at any time of the day, with or without meals, and can be injected subcutaneously in the abdomen, thigh or upper arm. No dose adjustment is required based on age. No dose adjustment is required in patients with mild, moderate or severe renal impairment. No dose adjustment is required based on hepatic impairment.

Key safety warnings

Gastrointestinal adverse reactions including nausea, vomiting and diarrhoea may occur especially at the initiation of treatment, and these events may lead to dehydration, which could cause a deterioration in renal function including acute renal failure. Dulaglutide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Acute pancreatitis has been reported with use of GLP-1 receptor agonists, including dulaglutide, and if confirmed, TRULICITY should be permanently discontinued. Patients receiving TRULICITY in combination with sulfonylurea or insulin may have an increased risk of hypoglycaemia, which may be lowered by a reduction in the dose of sulfonylurea or insulin. Pulmonary aspiration has been reported in patients receiving long acting GLP-1 receptor agonists undergoing general anaesthesia or deep sedation, and this should be considered prior to such procedures. Suicidal behaviour and ideation have been reported with GLP-1 receptor agonists; patients should be monitored for emergence or worsening of depression, suicidal thoughts or behaviours, and unusual changes in mood or behaviour, and benefits and risks should be considered for individual patients with suicidal thoughts or behaviours or a history of suicidal attempts.

Contraindications

TRULICITY is contraindicated in patients with known hypersensitivity to dulaglutide or any of the excipients in the product.

PBS listing

TRULICITY 1.5 mg in 0.5 mL single dose pre-filled pen has 2 PBS items listed with authority required and streamlined restrictions, at an ex-manufacturer price of A$111.44.

Regulatory history

TRULICITY dulaglutide (rch) 1.5 mg/0.5 mL solution for injection prefilled pen was first registered on the ARTG on 19 January 2015. An AusPAR was approved on 22 December 2014. In November 2017, the PBAC recommended TRULICITY for the treatment of type 2 diabetes mellitus in adult patients who have inadequate glycaemic control on dual oral therapy or on basal insulin, with authority required streamlined listing. The PBAC also recommended listing for the treatment of type 2 diabetes mellitus as dual or triple therapy in combination with metformin and/or a sulfonylurea, finding it acceptably cost-effective if cost minimised against exenatide. In July 2020, the PBAC recommended a change for use in combination with insulin and metformin. In May 2022, the PBAC recommended listing of 3 mg and 4.5 mg for type 2 diabetes mellitus in combination with metformin for patients contraindicated or intolerant to metformin and a sulfonylurea, with cost-effectiveness acceptable if cost-minimised against dulaglutide 1.5 mg. In July 2024, the PBAC rescinded the May 2022 recommendation.