OZEMPIC

What it is

Ozempic is semaglutide solution for injection. Semaglutide is a human glucagon-like-peptide-1 (GLP-1) receptor agonist produced in Saccharomyces cerevisiae by recombinant DNA technology followed by protein purification. Ozempic solution for injection is provided in a pre-filled multidose disposable pen, which contains semaglutide in a 1.5 mL or 3 mL cartridge. This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information.

Approved indications

— Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is not tolerated or contraindicated. — Treatment of adults with insufficiently controlled type 2 diabetes mellitus in addition to other medicinal products for the treatment of type 2 diabetes. — Adjunct to standard of care therapy to reduce the risk of sustained decline of kidney function and to reduce the risk of cardiovascular death in adults with type 2 diabetes and chronic kidney disease.

Dosing overview

Ozempic starting dose is 0.25 mg once weekly. After 4 weeks, the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly to further improve glycaemic control. Ozempic is to be administered once weekly, on the same day each week, at any time of the day, with or without meals. Ozempic is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm.

Key safety warnings

Cases of pulmonary aspiration have been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or deep sedation despite reported adherence to preoperative fasting recommendations. The increased risk of residual gastric content because of delayed gastric emptying should be considered prior to performing procedures with general anaesthesia or deep sedation. Acute pancreatitis, including fatal and non-fatal haemorrhagic or necrotising pancreatitis, has been observed with the use of GLP-1 receptor agonists. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Ozempic should be discontinued; if confirmed, Ozempic should not be restarted. Patients treated with Ozempic in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia. The risk of hypoglycaemia can be lowered by reducing the dose of sulfonylurea or insulin when initiating treatment with Ozempic. In patients with diabetic retinopathy treated with insulin and semaglutide, an increased risk of developing diabetic retinopathy complications has been observed. Caution should be exercised when using semaglutide in patients with diabetic retinopathy treated with insulin. There have been post-marketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require haemodialysis, in patients treated with GLP-1 receptor agonists. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhoea, or dehydration. Monitor renal function when initiating or escalating doses of Ozempic in patients reporting severe adverse gastrointestinal reactions. Suicidal behaviour and ideation have been reported with GLP-1 receptor agonists. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviours, and/or any unusual changes in mood or behaviour.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 List of Excipients.

PBS listing

Ozempic is listed on the PBS in three strengths: 2 mg in 1.5 mL pre-filled pen, 2 mg in 3 mL pre-filled pen, and 4 mg in 3 mL pre-filled pen. The ex-manufacturer price is A$111.44. Restriction types include streamlined and authority-required pathways.

Regulatory history

Ozempic 0.25/0.5 mg and 1 mg were first listed on the ARTG on 2019-08-28. The AusPAR approval date was 2019-08-15. In November 2017, the PBAC did not recommend Ozempic for the treatment of type 2 diabetes mellitus, citing uncertainty regarding cost-effectiveness. In November 2019, the PBAC recommended Ozempic for type 2 diabetes mellitus with inadequate glycaemic control as dual or triple therapy with metformin and/or sulfonylurea, with an Authority Required (Streamlined) listing on a cost-minimisation basis to dulaglutide. In March 2021, the PBAC recommended Ozempic for type 2 diabetes mellitus in combination with insulin and metformin. In November 2024, the PBAC recommended a General Schedule Authority Required (Telephone/Online) listing of 2 mg in 3 mL pre-filled injector pen, cost-minimised against 2 mg in 1.5 mL, with the two formulations considered equi-effective.