TRESIBA Solution for injection Ref.[107042] Active ingredients: Insulin degludec

2.1 Important Administration Instructions

• Always check insulin labels before administration [see Warnings and Precautions (5.4)].
• Inspect visually for particulate matter and discoloration. Only use TRESIBA if the solution appears clear and colorless.
• Inject TRESIBA subcutaneously into the thigh, upper arm, or abdomen.
• Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2), Adverse Reactions (6.1, 6.3)].
• During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)].
• For pediatric patients requiring less than 5 units of TRESIBA each day, use the TRESIBA U-100 vial.
• DO NOT administer TRESIBA intravenously or in an insulin infusion pump.
• DO NOT dilute or mix TRESIBA with any other insulin or solution.
• DO NOT transfer TRESIBA from the TRESIBA FlexTouch pen into a syringe for administration [see Warnings and Precautions (5.4)].
• Use TRESIBA FlexTouch pens with caution in patients with visual impairment that may rely on audible clicks to dial their dose.

2.2 General Dosing Instructions

• TRESIBA is available in 2 concentrations (U-100 and U-200):
  • TRESIBA U-100 is available, as a single-patient use FlexTouch pen and multiple-dose vial.
    • The FlexTouch pen delivers doses in 1 unit increments and can deliver up to 80 units in a single injection.
  • TRESIBA U-200 is available as a single-patient-use FlexTouch pen.
    • The FlexTouch pen delivers doses in 2 unit increments and can deliver up to 160 units in a single injection.
• DO NOT perform dose conversion when using the TRESIBA U-100 or U-200 FlexTouch pens. The dose window shows the number of insulin units to be delivered and no conversion is needed.
• In adults, inject TRESIBA subcutaneously once-daily at any time of day.
• In pediatric patients inject TRESIBA subcutaneously once-daily at the same time every day.
• Individualize and titrate the dose of TRESIBA based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal.
• The recommended days between dose increases are 3 to 4 days.
• Dose adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycemia or hyperglycemia [see Warnings and Precautions (5.3)].
• For adult patients, instruct patients who miss a dose of TRESIBA to inject their daily dose during waking hours upon discovering the missed dose. Instruct patients to ensure that at least 8 hours have elapsed between consecutive TRESIBA injections.
• For pediatric patients, instruct patients who miss a dose of TRESIBA to contact their healthcare provider for guidance and to monitor blood glucose levels more frequently until the next scheduled TRESIBA dose.
• In patients with type 1 diabetes, TRESIBA must be used concomitantly with short-acting insulin.

2.3 Starting Dose in Insulin Naïve Patients

Recommended Starting Dosage in Patients with Type 1 Diabetes Mellitus

The recommended starting dose of TRESIBA in insulin naïve patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose. The remainder of the total daily insulin dose should be administered as a short-acting insulin and divided between each daily meal. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin naïve patients with type 1 diabetes.

Recommended Starting Dosage in Patients with Type 2 Diabetes Mellitus

The recommended starting dose of TRESIBA in insulin naïve patients with type 2 diabetes mellitus is 10 units once daily.

2.4 Switching to TRESIBA from Other Insulin Therapies

Dosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to Insulin Degludec from another insulin therapy [see Warnings and Precautions (5.3)].

Adults with Type 1 or Type 2 Diabetes Mellitus

Start TRESIBA at the same unit dose as the total daily long or intermediate-acting insulin unit dose.

Pediatric Patients 1 Year of Age and Older with Type 1 or Type 2 Diabetes Mellitus:

Start TRESIBA at 80% of the total daily long or intermediate-acting insulin unit dose to minimize the risk of hypoglycemia [see Warnings and Precautions (5.2)].

An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.6)]. Mild episodes of hypoglycemia usually can be treated with oral glucose. Lowering the insulin dosage, and adjustment in meal patterns or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with a glucagon for emergency use or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid reoccurrence of hypoglycemia. Hypokalemia must be corrected appropriately.