FDA Approves Saxenda (liraglutide) for Weight Management in Adults and Adolescents

Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist. Not reported in label.

Saxenda is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity; adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of use: coadministration with other liraglutide-containing products or with any other GLP-1 receptor agonist is not recommended; safety and effectiveness in pediatric patients with type 2 diabetes have not been established.

Saxenda is injected subcutaneously once daily in the abdomen, thigh, or upper arm at any time of day, without regard to meals. The recommended dose is 3 mg daily. Initiate at 0.6 mg daily for one week, then increase weekly: 1.2 mg, 1.8 mg, 2.4 mg, then 3 mg from week 5 onward. For pediatric patients, dose escalation may take up to 8 weeks; if 3 mg is not tolerated, reduce to 2.4 mg daily. If a dose is missed, resume with the next scheduled dose; if more than 3 days have elapsed, reinitiate at 0.6 mg and follow the escalation schedule. In adult patients with type 2 diabetes, monitor blood glucose before and during treatment. Discontinue Saxenda in adults if <4% baseline weight loss at 16 weeks; in pediatric patients, discontinue if BMI reduction <1% after 12 weeks on maintenance dose.

Trial data not available in label.

Not reported in label.

Saxenda is a pharmacologic option for chronic weight management as an adjunct to lifestyle modification. It is not recommended for use with other GLP-1 receptor agonists or liraglutide-containing products. Its role is for patients who have not achieved adequate weight loss with diet and exercise alone.