Brand disclaimer image 1
Brand disclaimer image 2

RYBELSUS® 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);
  • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who have established CV disease or are at high risk for these events.

 

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.

 

Consult the RYBELSUS® Product Monograph at RYBELSUSPM-E.ca or here for important information on:

  • Contraindications in patients with personal or family history of medullary thyroid carcinoma (MTC), or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2); hypersensitivity to the formulation or container; pregnancy or breastfeeding
  • Most serious warnings and precautions about risk of thyroid C-cell tumours
  • Other relevant warnings and precautions about CV effects; hypoglycemia with concomitant use of insulin secretagogues or insulin; dizziness (initial dose escalation); driving and operating machinery; pancreatitis; hypersensitivity; diabetic retinopathy; delayed gastric emptying/risk of aspiration with general anaesthesia or deep sedation; monitor renal function in case of severe GI side effects/dehydration; limited experience in end-stage kidney disease; fertility; hepatic impairment; acute events of gall bladder disease; GLP-1 RA class potential for severe GI disease (ileus); not recommended in NYHA Class IV congestive heart failure; non-arteritic anterior ischemic optic neuropathy (NAION); sodium content
  • Conditions of clinical use, adverse reactions, drug interactions and dosing instructions.

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

 

* Comparative clinical significance has not been established.

CV, cardiovascular; CVD, cardiovascular disease; GI, gastrointestinal; GLP-1 RA, glucagon-like peptide-1 receptor agonist; MACE, major adverse cardiovascular event; T2D, type 2 diabetes.

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