LIRAGLUTIDE

What it is

Liraglutide is a human glucagon-like peptide-1 (GLP-1) analogue that binds to and activates the GLP-1 receptor (GLP-1R). Liraglutide is supplied as a solution for injection in a pre-filled pen containing 18 mg liraglutide in 3 mL.

Approved indications

— Weight management in adult patients with an initial Body Mass Index (BMI) of ≥30 kg/m² (obese) or ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea, as an adjunct to a reduced-calorie diet and increased physical activity.

Dosing overview

The starting dose is 0.6 mg once daily, increased to 3.0 mg daily in increments of 0.6 mg with at least one week intervals to improve gastrointestinal tolerability. Daily doses higher than 3.0 mg are not recommended. Liraglutide is for subcutaneous use only and is administered once daily at any time, independent of meals. Treatment should be discontinued after 12 weeks on the 3.0 mg/day dose if a patient has not lost at least 5% of their initial body weight.

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, and 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. An increase in heart rate with liraglutide was observed in clinical trials, and heart rate should be monitored at regular intervals consistent with good clinical practice. For patients who experience a sustained increase in resting heart rate, liraglutide should be discontinued. Patients treated with liraglutide should be advised of the potential risk of dehydration in relation to gastrointestinal side effects, as there have been reports of acute renal injury or failure in patients treated with GLP-1 receptor agonists, sometimes requiring haemodialysis. A majority of the reported events occurred in patients who had experienced nausea, vomiting, and diarrhoea leading to volume depletion. Acute pancreatitis has been observed with the use of GLP-1 receptor agonists; after initiation of liraglutide, observe patients carefully for signs and symptoms of pancreatitis, and if pancreatitis is suspected, liraglutide should be discontinued and appropriate management initiated. Liraglutide is not recommended for use in patients with a history of pancreatitis. Cholelithiasis or cholecystitis was reported more commonly in liraglutide-treated patients than in placebo-treated patients in clinical trials, the majority of liraglutide-treated patients with cholelithiasis or cholecystitis required cholecystectomy, and the incidence was greater in liraglutide-treated patients versus placebo-treated patients even after accounting for weight loss. There have been reports of serious hypersensitivity reactions in patients treated with liraglutide, and if a hypersensitivity reaction occurs, the patient should discontinue liraglutide and promptly seek medical advice. Do not use liraglutide in patients with a history of angioedema with another GLP-1 receptor agonist because such patients may be predisposed to angioedema with liraglutide. Suicidal behaviour and ideation have been reported with GLP-1 receptor agonists; patients treated with liraglutide should be monitored for the emergence of depression, suicidal thoughts or behaviour, or any unusual changes in mood or behaviour, and liraglutide should be discontinued in patients who experience suicidal thoughts or behaviours or who develop other symptoms of depression.

Contraindications

Liraglutide is not to be used in patients with hypersensitivity to liraglutide or any of its excipients.

PBS listing

Information regarding PBS listing for this medicine is not available in the provided sources.

Regulatory history

Liraglutide was first listed on the ARTG on 6 March 2025 (ARTG 428571 and ARTG 428572) as a solution for injection in a pre-filled pen. This medicinal product is subject to additional monitoring in Australia.