Indication:

Tresiba® is indicated for once-daily treatment of adults with diabetes mellitus to improve glycemic control.

Tresiba® is also indicated for the treatment of pediatric patients (≥2 years old) with type 1 diabetes mellitus.

Clinical use:

Not recommended for treatment of diabetic ketoacidosis.

Contraindication:

• During episodes of hypoglycemia

Most serious warnings and precautions:

Hypoglycemia is the most common adverse effect of insulin.

• Glucose monitoring is required
• Uncorrected hypo- or hyperglycemic reactions can cause loss of consciousness, coma and even death
• Use caution and medical supervision when converting insulin products

Administration

• Inspect visually prior to administration and only use if solution appears clear and colourless
• Do not mix with any other insulin, administer intravenously or use in insulin infusion pumps

Other relevant warnings and precautions:

• Refer to respective product monographs for concomitant oral antidiabetic agents for their warnings and precaution
  
• Stress or concomitant illness, especially infections and febrile conditions, may change insulin requirements
• Tresiba® should not be diluted
• Combination with thiazolidinediones (TZD) not indicated in type 2 diabetes; can cause heart failure and edema
• Risks associated with sharing insulin delivery devices
• Hyperglycemia
• Risk of hypokalemia
• Dosing may need to be adjusted in patients with renal and/or hepatic impairment
• Risk of immune responses (e.g., systemic allergic reactions, antibody production, or lipodystrophy and cutaneous amyloidosis)
• Treatment with Tresiba® can be considered during pregnancy, if the benefit justifies possible risks and if clinically needed
• Nursing women
• Pediatrics
• Geriatrics

For more information:
Please consult the Product Monograph here 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 us at 1-800-465-4334.