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.