What is the generic name?

LIRAGLUTIDE

What is the Trade Name for LIRAGLUTIDE?

Saxenda

What are the Indications for LIRAGLUTIDE?

• 1 INDICATIONS AND USAGE SAXENDA is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: ‚Ä¢ Adult patients with an initial body mass index (BMI) of [see Dosage and Administration ( 2.1 )] : ‚ñ™ 30 kg/m 2 or greater (obese), or ‚ñ™ 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia) ‚Ä¢ Pediatric patients aged 12 years and older with: ‚ñ™ body weight above 60 kg and ‚ñ™ an initial BMI corresponding to 30 kg/m2 or greater for adults (obese) by international cut-offs (Cole Criteria, Table 2) [see Dosage and Administration ( 2.1 )] Limitations of Use ‚ñ™ SAXENDA contains liraglutide and should not be coadministered with other liraglutide-containing products or with any other GLP-1 receptor agonist. ‚ñ™ The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established. ‚ñ™ The safety and effectiveness of SAXENDA in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. SAXENDA is a glucagon like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: Adult patients with an initial body mass index (BMI) of ‚Ä¢ 30 kg/m 2 or greater (obese), or ‚Ä¢ 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, or dyslipidemia) ( 1 ). Pediatric patients aged 12 years and older with: ‚Ä¢ body weight above 60 kg and ‚Ä¢ an initial BMI corresponding to 30 kg/m 2 for adults (obese) by international cut-offs ( 1 ). Limitations of Use: ‚Ä¢ SAXENDA contains liraglutide and should not be coadministered with other liraglutide-containing products or with any other GLP-1 receptor agonist. ( 1 ). ‚Ä¢ The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established ( 1 ). ‚Ä¢ The safety and efficacy of SAXENDA in combination with other products intended for weight loss have not been established ( 1) .

References: https://open.fda.gov/