SAXENDA

What it is

Liraglutide Sandoz contains liraglutide, a human glucagon-like peptide-1 (GLP-1) analogue that binds to and activates the GLP-1 receptor. Liraglutide Sandoz is a solution for injection in a pre-filled pen, with one pre-filled pen containing 18 mg liraglutide in 3 mL. It is for subcutaneous use only and is administered once daily at any time, independent of meals.

Approved indications

— Weight management in adult patients with an initial BMI of 30 kg/m² or greater (obese). — Weight management in adult patients with an initial BMI of 27 kg/m² to less than 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. — All indications are as an adjunct to a reduced-calorie diet and increased physical activity.

Dosing overview

The starting dose is 0.6 mg once daily, and the dose should be 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. 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; 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; heart rate should be monitored at regular intervals consistent with good clinical practice, and Liraglutide Sandoz should be discontinued for patients who experience a sustained increase in resting heart rate. Patients treated with Liraglutide Sandoz should be advised of the potential risk of dehydration in relation to gastrointestinal side effects; in patients treated with GLP-1 receptor agonists, including liraglutide, there have been reports of acute renal injury and failure, sometimes requiring haemodialysis. Acute pancreatitis has been observed with the use of GLP-1 receptor agonists; after initiation of Liraglutide Sandoz, observe patients carefully for signs and symptoms of pancreatitis, and if pancreatitis is suspected, Liraglutide Sandoz should be discontinued and appropriate management initiated; if acute pancreatitis is confirmed, Liraglutide Sandoz should not be restarted. Cholelithiasis or cholecystitis was reported more commonly in liraglutide-treated patients than in placebo-treated patients in clinical trials; 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 (such as anaphylactic reactions and angioedema) in patients treated with liraglutide; if a hypersensitivity reaction occurs, the patient should discontinue Liraglutide Sandoz and other suspect medicines and promptly seek medical advice. Suicidal behaviour and ideation have been reported with GLP-1 receptor agonists; patients treated with Liraglutide Sandoz should be monitored for the emergence of depression, suicidal thoughts or behaviour, or any unusual changes in mood or behaviour, and Liraglutide Sandoz should be discontinued in patients who experience suicidal thoughts or behaviours or who develop other symptoms of depression.

Contraindications

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

PBS listing

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

Regulatory history

Liraglutide Sandoz was first listed on the ARTG on 24 December 2015. The TGA approved Saxenda (liraglutide) on 23 December 2015 for chronic weight management, finding it effective in inducing weight loss in obese and overweight patients with weight-related comorbidities when used with diet and exercise. The safety profile was deemed acceptable, with common gastrointestinal adverse events generally being transient.