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Outline
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: • Adult patients with an initial body mass index (BMI) of [see Dosage and Administration ( 2.1 )] : ▪ 30 kg/m 2 or greater (obese), or ▪ 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) • Pediatric patients aged 12 years and older with: ▪ body weight above 60 kg and ▪ 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 ▪ SAXENDA contains liraglutide and should not be coadministered with other liraglutide-containing products or with any other GLP-1 receptor agonist. ▪ The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established. ▪ 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 • 30 kg/m 2 or greater (obese), or • 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: • body weight above 60 kg and • an initial BMI corresponding to 30 kg/m 2 for adults (obese) by international cut-offs ( 1 ). Limitations of Use: • SAXENDA contains liraglutide and should not be coadministered with other liraglutide-containing products or with any other GLP-1 receptor agonist. ( 1 ). • The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established ( 1 ). • The safety and efficacy of SAXENDA in combination with other products intended for weight loss have not been established ( 1) .
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