TRESIBA

AbsorptionIn patients with type 1 diabetes, after 8 days of once daily subcutaneous dosing with 0.4 units/kg of TRESIBA, maximum insulin degludec concentrations of 4472 pmol/L were attained at a median of 9 hours (t max ). After the first dose of TRESIBA, median onset of appearance was around one hour. Total insulin degludec concentration (i.e., exposure) increased in a dose proportional manner after subcutaneous administration of 0.4 units/kg to 0.8 units/kg TRESIBA. Total and maximum insulin ...

The efficacy of TRESIBA administered once-daily either at the same time each day or at any time each day in patients with type 1 diabetes and used in combination with a mealtime insulin was evaluated in three randomized, open-label, treat-to-target, active-controlled trials in adults and one randomized, open-label, treat-to-target, active-controlled trial in pediatric patients 1 year of age and older. The efficacy of TRESIBA administered once-daily either at the same time each day or at any time each day in adult patients with type 2 diabetes and used in combination with a mealtime insulin or ...

The following adverse reactions are also discussed elsewhere:

• Hypoglycemia [see Warnings and Precautions ( 5.3 )]
• Hypoglycemia due to Medication errors [see Warnings and Precautions ( 5.4 )]
• Hypersensitivity reactions [see Warnings and Precautions ( 5.5 )]
• Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse reactions commonly associated with TRESIBA are:
• hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain ( 6.1 ). To r...

TRESIBA is contraindicated:

• During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] .
• In patients with hypersensitivity to insulin degludec or any of the excipients in TRESIBA [see Warnings and Precautions ( 5.5 )] .
• During episodes of hypoglycemia ( 4 ).
• Hypersensitivity to insulin degludec or any of the excipients in TRESIBA ( 4 ).

• Never share a TRESIBA FlexTouch pen, insulin syringe, or needle between patients, even if the needle is changed ( 5.1 ).
• Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring ( 5.2 ).
• Hypoglycemia : May be life-threatening. Increase monitoring with changes to: insuli...

7 DRUG INTERACTIONS Table 5 includes clinically significant drug interactions with TRESIBA.

Table 5Clinically Significant Drug Interactions with TRESIBA Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, som...