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FDA approved Saxenda (liraglutide) for Weight Management in Adults and AdolescentsFDA approved Saxenda for weight management in adults and teens.

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Key Takeaway
Consider Saxenda as an adjunct to lifestyle changes for weight management in appropriate adult and pediatric patients.

The FDA has approved Saxenda (liraglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist, for chronic weight management. The indication covers adults with obesity (BMI ≥30) or overweight (BMI ≥27) with at least one weight-related comorbid condition, and pediatric patients aged 12 years and older with body weight >60 kg and obesity. Saxenda is to be used in combination with a reduced-calorie diet and increased physical activity. The approval provides a pharmacologic option for patients who have struggled with lifestyle modifications alone. Clinicians should note that Saxenda is not recommended for coadministration with other liraglutide-containing products or any other GLP-1 receptor agonist. The safety and effectiveness in pediatric patients with type 2 diabetes have not been established.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

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

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

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.

The FDA has approved a new drug called Saxenda (liraglutide) to help with weight management. Saxenda is for adults who have obesity (BMI of 30 or higher) or who are overweight (BMI of 27 or higher) and have at least one weight-related health problem, such as high blood pressure or type 2 diabetes. It is also approved for children aged 12 and older who weigh more than 60 kilograms (about 132 pounds) and have obesity. Saxenda is meant to be used along with a reduced-calorie diet and increased physical activity. This approval gives people who have struggled with weight loss through lifestyle changes alone a new medicine option. However, it is important to know that Saxenda is not recommended for use with other medicines that contain liraglutide or other GLP-1 receptor agonists. Also, its safety and effectiveness have not been studied in children with type 2 diabetes. If you think Saxenda might be right for you or your child, talk to your doctor about the risks and benefits. Your doctor can help you decide if this medicine is a good fit for your health needs and goals.

What this means for you:
Saxenda is a new weight loss drug for adults and teens, but it must be used with diet and exercise.

Study Details

Study typeFda approval
PublishedDec 2014
View Original Abstract ↓
1 INDICATIONS AND USAGE 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 • SAXENDA contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. • The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established. SAXENDA is a glucagon like peptide 1 (GLP-1) receptor agonist 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. ( 1 ) • Adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: • Coadministration with other liraglutide-containing products or with any other GLP-1 receptor agonist is not recommended. ( 1 ) • The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established. ( 1 )
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