Tresiba® is the only basal insulin indicated for type 1 & type 2 diabetes in children as young as 1 year of age

Here’s why once-daily Tresiba® may be appropriate for your pediatric patients

A flat and stable profile1-3

After steady state is achieved, the rate of insulin absorption and insulin elimination is equal.2


42+ hour duration of action1

Engineered to provide a long duration of action that won’t taper off at the end of the day.1,2,a


Tresiba® U-100 FlexTouch®

Tresiba® FlexTouch® is a prefilled insulin pen with no push-button extension.


Adult patients who miss a dose of Tresiba® should inject their daily dose during waking hours upon discovering the missed dose, then continue with their regular dosing schedule. Ensure that at least 8 hours have elapsed between Tresiba® injections.1 If a pediatric patient misses a dose, they should contact their health care provider for guidance and monitor blood glucose levels more frequently until the next scheduled dose.

Population pharmacokinetic analysis was conducted for Tresiba® using data from 199 pediatric subjects (1 to <18 years of age) with type 1 diabetes. Body weight was a significant covariate affecting the clearance of Tresiba®. After adjusting for body weight, the total exposure of Tresiba® at steady state was independent of age.

The safety and effectiveness of Tresiba® to improve glycemic control in type 1 and type 2 diabetes have been established in pediatric patients 1 year of age and older. The safety and effectiveness of Tresiba® have not been established in pediatric patients less than 1 year old. The use of Tresiba® in pediatric patients 1 year of age and older with type 1 and type 2 diabetes is supported by evidence from an adequate and well-controlled study and a pharmacokinetic study (studies included pediatric patients 1 year of age and older with type 1 diabetes mellitus). The use of Tresiba® in pediatric patients 1 year of age and older with type 2 diabetes is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes.

Child holding Tresiba®

Pediatric patient resource center

The amount of information families have to take in when starting a child on a diabetes care plan may be daunting. The Tresiba® pediatric resource center provides downloads about basal insulin therapy and managing blood glucose in children with diabetes as well as guidance for helping children and their families navigate a diagnosis.

Prescribing Tresiba®

For pediatric patients with type 1 and type 2 diabetes already taking insulin


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Start

Tresiba® at 80% of the current dose of basal insulin to minimize the risk of hypoglycemia

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Inject

Once daily at the same time of day

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Titrate

Every 3 to 4 days as needed


  • If a pediatric patient misses a dose, they should contact their health care provider for guidance and monitor blood glucose levels more frequently until the next scheduled dose
  • Tresiba® is not recommended for pediatric patients requiring less than 5 units
  • Individualize the dose according to the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goals, with 3 to 4 days between each dose increase

For insulin-naïve adult and pediatric patients with type 1 diabetes


Calculate

total daily insulin dose (basal + bolus)

0.2 to 0.4

units per kg of body weight

Plus

Start

initial Tresiba® dose at

1/3 to 1/2

of total daily insulin dose


  • The recommended starting dose of Tresiba® in insulin-naïve pediatric and adult patients with type 2 diabetes is 10 units once daily
  • Adults already taking insulin can start on the same unit dose as their current basal insulin, and take their injection at any time of day
  • Adult patients who miss a dose of Tresiba® should inject their daily dose during waking hours upon discovering the missed dose, then continue with their regular dosing schedule. Ensure that at least 8 hours have elapsed between Tresiba® injections

Dive deeper into Tresiba®



Eligible patients pay as little as $15 per prescriptionb

Log in to request Tresiba® FlexTouch® samplesc

aAfter the last of 8 once-daily injections (0.4 units/kg).

bFor up to 24 months. Maximum savings $500 per prescription. Eligibility and other restrictions apply.

cYou must be a licensed practitioner who can legally prescribe medication in your state. (Request for product samples is limited to 1 request per health care professional.)

Selected Important Safety Information

Contraindications

  • Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients

Warnings and Precautions

  • Never Share a Tresiba® FlexTouch® Pen Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens
  • Monitor blood glucose in all patients treated with insulin. Changes in insulin may affect glycemic control. These changes should be made cautiously and under medical supervision. Adjustments in concomitant oral anti-diabetic treatment may be needed
  • Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening

Indications and Usage

Tresiba® (insulin degludec injection) is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

Limitations of Use

Tresiba® is not recommended for treating diabetic ketoacidosis or for pediatric patients requiring less than 5 units of Tresiba®.

Important Safety Information

Contraindications

  • Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients

Warnings and Precautions

  • Never Share a Tresiba® FlexTouch® Pen Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens
  • Monitor blood glucose in all patients treated with insulin. Changes in insulin may affect glycemic control. These changes should be made cautiously and under medical supervision. Adjustments in concomitant oral anti-diabetic treatment may be needed
  • Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment
  • Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors, always instruct patients to check the insulin label before each injection
  • Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Tresiba®
  • As with all insulins, Tresiba® use can lead to life-threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated
  • Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Tresiba®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered

Adverse Reactions

  • Adverse reactions commonly associated with Tresiba® are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain

Drug Interactions

  • Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs and symptoms of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine)

Please click here for Prescribing Information.

 

References:

  1. Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2016.
  2. Heise T, Korsatko S, Nosek L, et al. J Diabetes. 2016;8(1):132-138.
  3. Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Diabetes Obes Metab. 2012;14(9):859-864.