WEGOVY

What it is

Wegovy is a human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology. It is supplied as a solution for injection in pre-filled pen and pre-filled syringe. The recommended maintenance dose is 2.4 mg once weekly, reached by dose escalation over a 16-week period starting with a weekly dose of 0.25 mg.

Approved indications

— Chronic weight management (including weight loss and weight maintenance) in adults as an adjunct to a reduced-energy diet and increased physical activity, with an initial Body Mass Index of ≥30 kg/m² (obesity), or ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity. — Weight management in adolescents ages 12 years and above with obesity and body weight above 60 kg, as an adjunct to a reduced-calorie diet and increased physical activity. — Reduction in risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with established cardiovascular disease, with a Body Mass Index of ≥27 kg/m², and without established Type 1 or Type 2 diabetes. — Treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

Dosing overview

The recommended maintenance dose is 2.4 mg once weekly. The dose is escalated over a 16-week period: 0.25 mg for weeks 1–4, 0.5 mg for weeks 5–8, 1 mg for weeks 9–12, and 1.7 mg for weeks 13–16. If patients do not tolerate the 2.4 mg dose, the dose can be decreased to 1.7 mg weekly for maintenance. Wegovy is administered once weekly at any time of the day, with or without meals, and is injected subcutaneously in the abdomen, thigh, or 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. Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. This should be considered when treating patients with impaired renal function as nausea, vomiting and diarrhoea may cause dehydration which could cause deterioration of renal function. There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which have in some cases required haemodialysis, in patients treated with semaglutide. Acute pancreatitis, including fatal and non-fatal haemorrhagic or necrotising pancreatitis, has been observed with the use of GLP-1 receptor agonists, including semaglutide. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Wegovy should be discontinued; if confirmed, Wegovy should not be restarted. 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.

Regulatory history

Wegovy received TGA approval on 25 March 2022 for chronic weight management in adults. Initial ARTG registration entries for Wegovy single-dose pens (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg doses) were listed on 1 September 2022. Wegovy FlexTouch pens were subsequently registered on 30 May 2024, and pre-filled syringes were registered on 3 March 2026. The MASH indication was approved via the provisional approval pathway based on resolution of steatohepatitis and improvement in liver fibrosis, with continued approval depending on verification and description of clinical benefit in confirmatory trials.