Indication and clinical use:
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:
- 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.
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).
- Personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Pregnant or breastfeeding women
Most serious warnings and precautions:
Risk of Thyroid C-Cell Tumours: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumours in both genders of rats and mice. It is unknown whether liraglutide causes thyroid C-cell tumours, including MTC, in humans. Patients should be counselled regarding the risk and symptoms of thyroid tumours.
Other relevant warnings and precautions:
- Combination use with other weight loss products has not been established
- Should not be administered intravenously or intramuscularly
- Risk of increased heart rate and PR interval prolongation; monitor consistent with usual clinical practice
- Risk of hypoglycemia in adult patients with type 2 diabetes mellitus; should not be used together with insulin; safety and effectiveness in pediatric patients with type 2 diabetes have not been established
- Observe patients carefully for signs and symptoms of acute pancreatitis
- Acute gallbladder disease
- Risk of hypersensitivity and angioedema
- Breast neoplasms
- Avoid use in patients with a history of suicidal attempts or active suicidal ideation
- Caution in patients with recent myocardial infarction, unstable angina, and congestive heart failure
- Not recommended in patients with hepatic insufficiency
- Caution when initiating or escalating doses in patients with renal insufficiency; not recommended in patients with severe renal insufficiency
- Should not be used by patients with inflammatory bowel disease or diabetic gastroparesis
For more information:
Please consult the Product Monograph at https://www.novonordisk.ca/content/dam/nncorp/ca/en/products/saxenda-product-monograph.pdf for more information relating to adverse reactions, drug interactions, and dosing information, which have not been discussed in this piece.
The Product Monograph is also available by calling Novo Nordisk at 1-800-465-4334.