Tresiba

TRESIBA- insulin degludec injection, solution
Novo Nordisk

1 INDICATIONS AND USAGE

TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

Limitations of Use

o
Not recommended for the treatment of diabetic ketoacidosis.

2 DOSAGE AND ADMINISTRATION

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.
Use TRESIBA with caution in patients with visual impairment that may rely on audible clicks to dial their dose.
DO NOT administer TRESIBA intravenously or in an insulin infusion pump.
DO NOT dilute or mix TRESIBA with any other insulin products or solutions.
DO NOT transfer TRESIBA from the TRESIBA pen into a syringe for administration [see Warnings and Precautions (5.4)].

2.2 General Dosing Instructions

TRESIBA is available in 2 concentrations (U-100 and U-200):
o
TRESIBA U-100 concentration is available in 2 presentations, FlexTouch pen and vial
Single-patient-use TRESIBA U-100 FlexTouch pen contains 300 units of TRESIBA U-100. It delivers doses in 1 unit increments and can deliver up to 80 units in a single injection.
TRESIBA U-100 multiple-dose vial contains 1000 units of TRESIBA U-100. Use vial only with a U-100 insulin syringe.
o
TRESIBA U-200 concentration is only available in a FlexTouch pen
Single-patient-use TRESIBA U-200 FlexTouch pen contains 600 units of TRESIBA U-200. It 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 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.

2.3 Starting Dose in Insulin Naïve Patients

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.

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 Starting Dose in Patients Already on Insulin Therapy

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)].

3 DOSAGE FORMS AND STRENGTHS

Injection: TRESIBA is available as a clear and colorless solution:

100 units/mL (U-100): 3 mL single-patient-use FlexTouch disposable prefilled pen
100 units/mL (U-100): 10 mL multiple-dose vial
200 units/mL (U-200): 3 mL single-patient-use FlexTouch disposable prefilled pen

4 CONTRAINDICATIONS

TRESIBA is contraindicated:

During episodes of hypoglycemia [see Warnings and Precautions (5.3)].
In patients with hypersensitivity to TRESIBA or one of its excipients [see Warnings and Precautions (5.5)].

5 WARNINGS AND PRECAUTIONS

5.1 Never Share a TRESIBA FlexTouch Pen, Needle, or Syringe Between Patients

TRESIBA FlexTouch disposable prefilled pens should never be shared between patients, even if the needle is changed. Patients using TRESIBA vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions ( 5.3 )] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions ( 6.1 , 6.3 )].

Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, adjustments in concomitant anti-diabetic treatment may be needed. When converting from other insulin therapies to TRESIBA follow dosing recommendations [see Dosage and Administration (2.4)].

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