Tresiba® is the only basal insulin indicated for patients 1 year and older with diabetes1-5

A flat, stable profile1,6,7

A smooth and steady release provides continuous coverage for longer than 24 hours

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42+ hour duration of action1

Provides a long duration of action that won’t taper off at the end of the day1,6,a

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Tresiba® FlexTouch® U-100 pen and vial

Available in a prefilled insulin pen with no push-button extension and a multiple-dose, 10-mL vial

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

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. 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

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.

Start your pediatric patients on Tresiba® now

Start your pediatric patients on Tresiba® now

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

Available in a vial ▾

Standard insulin pen

Hand Holding Injector Pen

Tresiba® FlexTouch® U-100

Hand holding FlexTouch®

No matter what dose is dialed, the Tresiba® FlexTouch® U‑100 push button doesn’t extend any higher.

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Contains 300 total units


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Maximum dose of 80 units in a single injection


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1-unit dose increments


After opening, Tresiba® may be used for up to 8 weeks when kept at room temperature or in the refrigerator vs 4 weeks for insulin glargine U-100.1,2,a,b

aOpened (in-use) Tresiba® should be refrigerated (36°F to 46°F [2°C to 8°C]) or kept at room temperature (below 86°F [30°C]), away from direct heat and light.1
bOpened (in-use) Lantus® SoloSTAR® device must be discarded 4 weeks after being opened. Once in use, the device must be kept at room temperature.2

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Variety for patients who prefer vials1

  • Contains 1000 total units
  • Option for children who need fewer than 5 units per day

Once in use, the Tresiba® vial lasts 8 weeks, 2X as long as the insulin glargine U-100 vial, and 2 weeks longer than the insulin detemir vial.1-3,c,d

cIn-use Tresiba® can be kept at room temperature (below 86°F), away from direct heat and light, or refrigerated (36°F-46°F).
dThe in-use insulin glargine U-100 vial must be discarded after 4 weeks and the in-use insulin detemir vial must be discarded after 6 weeks.2,3

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Conversations with caregivers and patients after a diabetes diagnosis

Below are some ways to address concerns caregivers may have about diabetes and basal insulin therapy. Use these talking points as you navigate through tough conversations following diagnosis.

FlexTouch® Needle

Injecting

Addressing fears about needles:

  • Tresiba® uses NovoFine® Plus needles, the shortest and thinnest available from Novo Nordisk
  • Advise caregivers to create a calm environment, maybe a favorite show on a tablet can help
  • Don't rush or seem anxious, but make the injection as fast as possible. Slower is not better

Diet

Encouraging healthy eating:

  • Suggest that caregivers focus on balance, framing talks about diet in a way that allows for creativity and choice
  • Remind caregivers that eating balanced meals isn’t a punishment for children, it’s something everyone should be doing
Green Person

Exercise

Advocating for regular activity:

  • Remind caregivers to leverage their child’s natural curiosity, taking them on a walk or to the park 
  • Encourage kids to play sports, but be sure to educate others on the signs of hypoglycemia and carry snacks or glucose tablets in case the child's blood sugar gets too low
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Forming Healthy Habits

Being a role model:

  • Encourage parents to get involved in routines and keep a positive attitude 
  • Advise parents and caretakers to reward or recognize healthy habits
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These trusted partners are helping young patients with diabetes

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More of your patients may now be covered for Tresiba®

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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, Needle, or Syringe 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
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia 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. 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. Adjustments in concomitant 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.

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, Needle, or Syringe 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
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia 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. 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. Adjustments in concomitant 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

  • There are certain drugs that may cause clinically significant drug interactions with Tresiba®.
    • Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors
    • Drugs that may decrease the blood glucose lowering effect: atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones
    • Drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine
    • Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine

Please click here for Prescribing Information

 

 

References:

  1. Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; November 2019.
  2. Lantus [package insert]. Bridgewater, NJ: sanofi-aventis US LLC; November 2018.
  3. Levemir [package insert]. Plainsboro, NJ: Novo Nordisk Inc; March 2020.
  4. Toujeo [package insert]. Bridgewater, NJ: sanofi-aventis US LLC; March 2019.
  5. Basaglar [package insert]. Indianapolis, IN: Lilly USA LLC; June 2016.
  6. Heise T, Korsatko S, Nosek L, et al. J Diabetes. 2016;8(1):132-138.
  7. Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Diabetes Obes Metab. 2012;14(9):859-864.