Saxenda® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for 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 or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.1
Treatment with Saxenda® should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight.1
Clinical study adverse events
In the SCALE clinical study, the most common adverse events experienced with Saxenda® were GI disorders1,2. The 4-week dose-escalation schedule was designed to minimise GI symptoms and most GI symptoms were mild to moderate and transient 1. While some patients withdrew due to adverse events (9.9% with Saxenda® vs 3.8% with placebo), overall, more patients completed the trial with Saxenda® than with placebo (72% vs 64%, respectively)2.
Adverse reactions to Saxenda®1
Please refer to the full SMPC for the complete list of safety and adverse events.
Adverse reactions reported with Saxenda are listed in the following table:
*Hypoglycaemia (based on self-reported symptoms by patients and not confirmed by blood glucose measurements) reported in patients without type 2 diabetes mellitus treated with Saxenda in combination with diet and exercise.
**Insomnia was mainly seen during the first 3 months of treatment.
† In clinical trials for weight management, a higher rate of cholelithiasis and cholecystitis was observed in patients treated with Saxenda® than in patients on placebo. The fact that substantial weight loss can increase the risk of cholelithiasis and thereby cholecystitis only partially explained the higher rate with Saxenda®. Cholelithiasis and cholecystitis may lead to hospitalisation and cholecystectomy. Patients should be informed of the characteristic symptoms of cholelithiasis and cholecystitis.
‡ Acute 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, Saxenda® should be discontinued; if acute pancreatitis is confirmed, Saxenda® should not be restarted.
§From controlled phase 2, 3a and 3b clinical trials.
Special warnings and precautions for use1
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Patients with heart failure
There is no clinical experience in patients with congestive heart failure New York Heart Association (NYHA) class IV, and liraglutide is therefore not recommended for use in these patients.
The safety and efficacy of liraglutide for weight management have not been established in patients:
- aged 75 years or more,
- treated with other products for weight management,
- with obesity secondary to endocrinological or eating disorders or to treatment with medicinal products that may cause weight gain,
- with severe renal impairment,
- with severe hepatic impairment.
Use in these patients is not recommended
As liraglutide for weight management was not investigated in subjects with mild or moderate hepatic impairment, it should be used with caution in these patients.
There is limited experience in patients with inflammatory bowel disease and diabetic gastroparesis. Use of liraglutide is not recommended in these patients since it is associated with transient gastrointestinal adverse reactions, including nausea, vomiting and diarrhoea.
Acute 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, liraglutide should be discontinued; if acute pancreatitis is confirmed, liraglutide should not be restarted.
Cholelithiasis and cholecystitis
In clinical trials for weight management, a higher rate of cholelithiasis and cholecystitis was observed in patients treated with liraglutide than in patients on placebo. The fact that substantial weight loss can increase the risk of cholelithiasis and thereby cholecystitis only partially explained the higher rate with liraglutide. Cholelithiasis and cholecystitis may lead to hospitalisation and cholecystectomy. Patients should be informed of the characteristic symptoms of cholelithiasis and cholecystitis.
In clinical trials in type 2 diabetes, thyroid adverse events, such as goitre, have been reported in particular in patients with pre-existing thyroid disease. Liraglutide should therefore be used with caution in patients with thyroid disease.
An increase in heart rate was observed with liraglutide in clinical trials. Heart rate should be monitored at regular intervals consistent with usual clinical practice. Patients should be informed of the symptoms of increased heart rate (palpitations or feelings of a racing heartbeat while at rest). For patients who experience a clinically relevant sustained increase in resting heart rate, treatment with liraglutide should be discontinued.
Signs and symptoms of dehydration, including renal impairment and acute renal failure, have been reported in patients treated with GLP-1 receptor agonists. Patients treated with liraglutide should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion.
Hypoglycaemia in patients with type 2 diabetes mellitus
Patients with type 2 diabetes mellitus receiving liraglutide in combination with insulin and/or sulfonylurea may have an increased risk of hypoglycaemia. The risk of hypoglycaemia may be lowered by a reduction in the dose of insulin and/or sulfonylurea.
Hyperglycaemia in insulin treated patients with diabetes mellitus
In patients with diabetes mellitus, Saxenda® must not be used as a substitute for insulin; diabetic ketoacidosis has been reported in insulin-dependent patients after rapid discontinuation or dose reduction of insulin.
Hypersensitivity to liraglutide or to any of the following excipients:
- Disodium phosphate dihydrate
- Propylene glycol
- Hydrochloric acid (for pH adjustment)
- Sodium hydroxide (for pH adjustment)
- Water for injections
Reporting adverse events
- Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
- Adverse events should also be reported to Novo Nordisk Limited (Telephone Novo Nordisk Customer Care Centre 0845 6005055). Calls may be monitored for training purposes.
- Saxenda® Summary of Product Characteristics
- Pi-Sunyer X, Astrup A, Fujioka K, et al; for the SCALE Obesity and Prediabetes NN8022-1839 Study Group. A randomized, controlled trial of 3.0 mg of liraglutide in weight management. N Engl J Med. 2015;373(1):11-22 and supplementary appendix.