Safety Information

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).


Contraindications:

  • 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
  • Breast neoplasms
  • Cardiovascular effects: increased heart rate, PR interval prolongation
  • Use in recent myocardial infarction, unstable angina, and congestive heart failure
  • Driving and operating machinery
  • Risk of hypoglycemia in patients with type 2 diabetes mellitus; should not be used with insulin
  • Gastrointestinal disease
  • Hepatic insufficiency
  • Acute pancreatitis and gallbladder disease
  • Hypersensitivity reactions
  • Suicidal behaviour and ideation
  • Use in renal insufficiency

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.