SAFETY INFORMATION

Indications and clinical use:

RYBELSUS® (semaglutide tablets) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus:

  • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications

  • in combination with other medicinal products for the treatment of diabetes (see clinical trials in the Product Monograph for patient populations and drug combinations tested)

RYBELSUS® is not indicated for use in type 1 diabetes or for the treatment of diabetic ketoacidosis. RYBELSUS® is not indicated for use in pediatric patients. Greater sensitivity of some older individuals cannot be ruled out. Therapeutic experience in patients ≥ 75 years of age is limited.

Contraindications:

  • Personal or family history of medullary thyroid carcinoma (MTC), or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

  • Pregnancy or breastfeeding

Most serious warnings and precautions:

Risk of thyroid C-cell tumours: In both genders of rats and mice, semaglutide caused treatment-dependent thyroid C-cell tumours at clinically relevant exposures. It is unknown whether semaglutide causes thyroid C-cell tumours in humans. Patients should be counselled regarding the risk and symptoms of thyroid tumours.

Relevant warnings and precautions:

  • Hypoglycemia with concomitant use of insulin secretagogues or insulin

  • Driving and operating machinery

  • CV effects: increased heart rate; PR interval prolongation

  • Pancreatitis

  • Hypersensitivity

  • Diabetic retinopathy: In patients with history of disease, monitor for worsening

  • Renal insufficiency: Severe GI adverse reactions warrant monitoring of renal function; acute renal failure and worsening of chronic renal failure have been reported

  • Fertility

  • Hepatic impairment

For more information:

Please consult the Product Monograph at https://www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/OurProducts/PDF/Rybelsus-PM-EN-monograph.pdf for more information relating to adverse reactions, drug interactions, and dosing information, which have not been discussed in this advertisement.

The Product Monograph is also available by calling us at 1-800-465-4334.