1. Saxenda® Product Monograph. Novo Nordisk
Canada Inc. November 3, 2021.
Saxenda® (liraglutide injection) 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:1
30 kg/m2 or greater (obesity), or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes, or dyslipidemia) and who have failed a previous weight management intervention.
Pediatric patients aged 12 to less than 18 years with:1
an inadequate response to reduced calorie diet and increased physical activity alone, and
a body weight above 60 kg (132 lbs), and
an initial body mass index (BMI) corresponding to ≥30 kg/m2 for adults (obesity) by international cut-offs
Limitations of Use:
Clinical efficacy and safety data from patients with BMI 27 to 29.9 kg/m2 in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia) are limited (N = 149).
The safety and effectiveness of Saxenda® in pediatric patients with type 2 diabetes have not been established.
Contraindications in patients with personal or family history of medullary thyroid carcinoma (MTC), Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), pregnant and breastfeeding women
The most serious warning and precaution regarding the risk of thyroid C-cell tumours
Other relevant warnings and precautions regarding combination use with other weight loss products, administration considerations; risk of increased heart rate and PR interval prolongation; use in patients with type 2 diabetes mellitus; risk of acute pancreatitis or gallbladder disease; risk of hypersensitivity and angioedema; risk of breast neoplasms; use in patients with suicidal behaviour and ideation; use in patients with recent myocardial infarction, unstable angina and congestive heart failure; use in patients with hepatic or renal insufficiency, inflammatory bowel disease or diabetic gastroparesis
Conditions of clinical use, adverse reactions, drug interactions and dosing instructions
The Product Monograph is also available by calling Novo Nordisk at 1-800-465-4334.